Internal HaemorrhoidsAIN-MPFFNCT07899229
Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome
A study testing Auricular Indwelling Needles and Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin) in people with Internal Haemorrhoids, run by University of Medicine and Pharmacy at Ho Chi Minh City.
Trial summary
The goal of this clinical trial is to learn if adding small ear needles to a standard oral medicine can ease symptoms in adults with early-stage internal hemorrhoids (swollen blood vessels inside the anus, grade I-II) who also have the "heat-toxin syndrome" of traditional medicine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Internal Haemorrhoids
- What is being tested?
- Auricular Indwelling Needles and Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2026to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female outpatients aged 18 years or older attending Le Van Thinh Hospital.
- Confirmed diagnosis of Grade I or Grade II internal hemorrhoids according to the Goligher classification (based on the 2020 Vietnam Ministry of Health Guidelines and the 2024 American Society of Colon and Rectal Surgeons [ASCRS] Clinical Practice Guidelines), verified by clinical examination and rigid anoscopy.
- Presence of both of the following clinical symptom thresholds at baseline:
- Anal pain or discomfort during defecation with a Visual Analogue Scale (VAS) score >= 3 points (on a 0-10 scale).
- Bright red rectal bleeding during defecation, with or without spontaneously reducible hemorrhoidal prolapse.
- Confirmed diagnosis of Traditional Medicine Heat-Toxicity Syndrome (Hoi chung Nhiet doc, per the 2020 Vietnam Ministry of Health Guidelines and the 2020 Chinese Association of Integrative Medicine Guidelines for Hemorrhoids), requiring fulfillment of all three of the following conditions:
Show all 11Show fewer
- Primary symptoms: Presence of BOTH (a) bright red bleeding during defecation and (b) anal burning sensation; (c) prolapsed hemorrhoidal mass outside the anus may be present or absent.
- Secondary symptoms: Presence of at least 2 of the following 3 symptoms: (a) dry, hard stools; (b) scanty dark-yellow urine; (c) dry throat and bitter taste in the mouth.
- Tongue and pulse signs: Red tongue body with a yellow, greasy coating, and a slippery, rapid pulse (mach hoat sac).
- Naive to auricular press needle therapy (never previously treated with auricular press needles).
- Voluntarily agrees to participate in the study and signs the written informed consent form.
Who cannot join
- Indication for surgical hemorrhoidectomy or urgent procedural intervention, including Grade III or Grade IV internal hemorrhoids, large symptomatic external hemorrhoids, thrombosed hemorrhoids, or strangulated/incarcerated hemorrhoids.
- History or current presence of other colorectal or anal conditions causing hematochezia, including colorectal polyps, colorectal cancer, inflammatory bowel disease (Crohn's disease, ulcerative colitis), diverticulitis, anal fissure, or anal fistula.
- History or presence of cognitive impairment or psychiatric disorders, including bipolar disorder, anxiety disorder, depressive disorder, or schizophrenia.
- Congenital or acquired auricular abnormalities or ear conditions, including unilateral or bilateral congenital microtia/anotia, congenital deafness, auricular chondritis, or active skin infection/dermatitis on the auricle.
- Known hypersensitivity or allergy to metal needles, adhesive tape, or any component of the auricular press needles, severe needle phobia, or a history of acupuncture syncope (needle fainting).
- Severe systemic comorbidities (uncontrolled cardiovascular or respiratory diseases), history of malignancy or active cancer treatment, or unexplained weight loss.
- Hepatic or renal dysfunction, known hypersensitivity to Diosmin, Hesperidin, or any excipient of Daflon 500 mg, or pregnancy.
- Concurrent participation in another interventional clinical trial involving medications or medical procedures.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Efficacy of Auricular Indwelling Needles as an Adjunct to Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin) in Goligher Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome: A Randomized, Participant-Blind, Sham-Controlled Trial
The goal of this clinical trial is to learn if adding small ear needles to a standard oral medicine can ease symptoms in adults with early-stage internal hemorrhoids (swollen blood vessels inside the anus, grade I-II) who also have the "heat-toxin syndrome" of traditional medicine. In this pattern, people typically have bright red bleeding when passing stool, a burning feeling in the anus, dry stool, dark yellow urine, a dry throat with a bitter taste, a red tongue with a greasy yellow coating, and a rapid pulse. The trial will also learn about the safety of the ear needles.
The main questions it aims to answer are:
Read more
Does adding ear needles to the standard medicine lower anal discomfort or pain during bowel movements after 14 days? Does it also reduce bleeding and prolapse (hemorrhoids that come out of the anus) and improve quality of life? What side effects do participants have with the ear needles and with the medicine?
Researchers will compare two groups to see if the ear needles help beyond the standard medicine alone. One group will receive ear needles and the other will receive look-alike ear patches with the needle removed (a "sham" treatment, used so that participants cannot tell which treatment they received). Both groups will take the same medicine, diosmin/hesperidin (Daflon 500 mg), and receive the same diet and lifestyle advice.
Participants will:
Take Daflon 500 mg tablets for 14 days Have ear needles or sham patches placed on seven points of one ear on Day 0 and Day 7 (switching ears each time), and have them removed on Day 5 and Day 12 Press the needles or patches gently at least 3 times a day for 1 minute each time Visit the clinic on Day 0, Day 7 and Day 14 to report their pain (on a 0-10 scale), bleeding and prolapse, and to complete a quality-of-life questionnaire (Day 0 and Day 14) Report any side effects to the study team
Read the detailed description
Rationale. MPFF improves venous tone and is a standard conservative treatment, yet residual anal discomfort or pain is common and affects quality of life. Auricular points related to the anorectal region may relieve pain and bleeding through neuromodulation. In traditional medicine, a large share of patients with internal hemorrhoids present with the heat-toxin syndrome. Auricular indwelling needles provide continuous stimulation with low invasiveness, but controlled evidence in this population is limited.
Objectives. To compare auricular indwelling needles plus MPFF with sham patches plus MPFF in adults with Goligher grade I-II internal hemorrhoids and the heat-toxin syndrome, regarding (1) anal discomfort/pain during defecation (VAS) at Day 7 and Day 14; (2) bright red bleeding and prolapse at Day 7 and Day 14; (3) quality of life (EQ-5D-5L) at Day 14; (4) adverse events during 14 days.
Design and setting. Randomized, participant-blinded, sham-controlled, two-arm parallel trial at the outpatient clinics of Le Van Thinh Hospital, Ho Chi Minh City, Vietnam. A surgeon confirms internal hemorrhoids of Goligher grade I-II. A traditional medicine physician confirms the heat-toxin syndrome using the criteria in the eligibility section, adapted from the Vietnam Ministry of Health guideline (2020) and the Chinese hemorrhoid guideline of the Chinese Association of Integrative Medicine (2020). Participants give written informed consent.
Randomization and blinding. The allocation sequence (1:1, simple randomization) was generated before enrollment with the RAND function of Microsoft Excel. Group codes are kept in sequentially numbered, sealed, opaque envelopes, opened by the treating physician only after eligibility is confirmed and consent is signed. Participants are told only their group letter (A or B) and are not told how the groups differ. The treating physician cannot be blinded.
Interventions. Both groups: MPFF (Daflon 500 mg; diosmin 450 mg and hesperidin 50 mg per tablet) for 14 days (3 tablets twice daily for 4 days, 2 tablets twice daily for 3 days, then 1 tablet twice daily for 7 days), plus advice on a high-fiber diet, adequate fluids, avoiding spicy food, alcohol and tobacco, and avoiding prolonged sitting or standing. Experimental group: Khanh Phong auricular indwelling needles (0.22 x 1.3 mm) at seven points: Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7) and Sanjiao (CO17), one ear per session, alternating ears (right ear first). Session 1 runs from Day 0 to Day 5 and session 2 from Day 7 to Day 12, with a 2-day ear-free interval. Participants press the needles at least 3 times daily for 1 minute. Sham group: identical patches with the needle removed, applied at the same points, on the same schedule and with the same instructions.
Assessments. VAS, bleeding grade and prolapse grade at Day 0, Day 7 and Day 14; EQ-5D-5L at Day 0 and Day 14; adverse events throughout the 14 days.
Sample size. Calculated for a two-group comparison of means for the VAS change (two-sided alpha 0.05, power 80%), assuming a between-group difference of 1.73 points (Cohen's d = 0.75) and SD 2.31, giving 28 participants per group. A 10% allowance gives 32 per group (64 in total).
Statistical analysis. Stata 17. Continuous variables: mean (SD) or median (IQR). Categorical variables: n (%). Between-group comparisons: t-test or Mann-Whitney U test for continuous and ordinal data, chi-square or Fisher's exact test for categorical data. Within-group changes: paired t-test or Wilcoxon signed-rank test.
Safety and discontinuation. Needle fainting, local inflammation, intolerable pain and bleeding at the needle site are managed according to the Vietnam Ministry of Health acupuncture procedures. Participants who develop heavy rectal bleeding or other emergency signs have the needles removed and are referred to the hospital's surgical or emergency department; serious events are reported to the ethics committee within 24 hours. Participants are withdrawn if they decide to stop, develop serious allergy or complications, or start other hemorrhoid treatments.
- Conditions
- Internal Haemorrhoids
- Being tested
- Auricular Indwelling Needles, Sham Auricular Indwelling Needles, Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin)
- Keywords
- Hemorrhoids, Auricular acupuncture, Auricular indwelling needle, Micronized purified flavonoid fraction, Diosmin, Hesperidin, Traditional medicine, Heat-toxin syndrome, Vietnam
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auricular Indwelling NeedlesDevice
Also called Khanh Phong Press Needles, Auricular Press Needles, Tianxie Disposable Press Needles (0.22 x 1.3 mm), Auricular Acupuncture
Sterile, single-use intradermal auricular press needles (Khanh Phong / Tianxie brand, dimensions 0.22 x 1.3 mm, approved by the Vietnam Ministry of Health under Decision No. 287/BYT-YDCT) are inserted perpendicularly to a depth of 1.3 mm after 70% isopropyl alcohol disinfection at 7 auricular acupoints: Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7), and Triple Energizer (CO17). Treatment consists of 2 cycles over 14 days: Cycle 1 on the right ear (inserted on Day 0, removed on Day 5, followed by a 2-day rest period) and Cycle 2 on the left ear (inserted on Day 7, removed on Day 12). Participants press the plastered acupoints at least 3 times per day for 1 minute per session to elicit mild soreness, warmth, or distension (Deqi sensation).
Sham Auricular Indwelling NeedlesDevice
Also called on-penetrating Sham Auricular Patches, Placebo Press Needles, Placebo Indwelling Needles
Identical adhesive patches (Khanh Phong / Tianxie brand) from which the stainless-steel microneedle tip has been completely removed so that no skin penetration or mechanical needle stimulation occurs. Following 70% isopropyl alcohol disinfection, the sham patches are adhered to the exact same 7 unilateral auricular acupoints-Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7), and Triple Energizer (CO17)-on the right ear for Cycle 1 (Day 0 to Day 5) and the left ear for Cycle 2 (Day 7 to Day 12). Participants are instructed to press the patches at least 3 times per day for 1 minute per session, identical to the active intervention group.
Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin)Drug
Also called Daflon 500 mg, MPFF (Diosmin 450 mg / Hesperidin 50 mg)
Oral film-coated tablets containing 500 mg of Micronized Purified Flavonoid Fraction (450 mg micronized Diosmin and 50 mg Hesperidin; Daflon 500 mg, manufactured by Servier, France; Vietnam Drug Administration registration No. 3109/QLD-DK). Administered orally for 14 days per the Vietnam Ministry of Health acute hemorrhoidal regimen (Decision No. 5013/QD-BYT): 3 tablets twice daily (3,000 mg/day) for the first 4 days (Days 1 - 4), followed by 2 tablets twice daily (2,000 mg/day) for the next 3 days (Days 5 - 7), and 1 tablet twice daily (1,000 mg/day) for the subsequent 7 days (Days 8 - 14). All participants also receive standardized dietary and lifestyle counseling (high-fiber diet, 1.5 - 2 L water/day, avoidance of spicy food/alcohol/prolonged sitting or straining).
| Study group | Role | What they receive |
|---|---|---|
| Auricular Indwelling Needles Plus Micronized Purified Flavonoid Fraction (Group A) | Experimental | Participants receive standard conservative therapy including dietary/lifestyle counseling and oral Micronized Purified Flavonoid Fraction (Daflon 500 mg: Diosmin 450 mg + Hesperidin 50 mg) for 14 days (3 tablets twice daily for Days 1-4, 2 tablets twice daily for Days 5-7, and 1 tablet twice daily for Days 8-14), combined with Real Auricular Indwelling Needles (0.22 x 1.3 mm) inserted at 7 unilateral auricular acupoints: Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7), and Triple Energizer (CO17). Needles are applied in 2 cycles: Cycle 1 on the right ear from Day 0 to Day 5 (retained for 5 days, followed by a 2-day rest period), and Cycle 2 on the left ear from Day 7 to Day 12 (retained for 5 days). Participants manually press the needles at least 3 times daily for 1 minute each time. Receives: Device: Auricular Indwelling Needles; Drug: Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin) |
| Sham Auricular Indwelling Needles Plus Micronized Purified Flavonoid Fraction (Group B) | Sham comparator | Participants receive the exact same standard conservative therapy including dietary/lifestyle counseling and oral Micronized Purified Flavonoid Fraction (Daflon 500 mg: Diosmin 450 mg + Hesperidin 50 mg) for 14 days (3 tablets twice daily for Days 1-4, 2 tablets twice daily for Days 5-7, and 1 tablet twice daily for Days 8-14), combined with Sham Auricular Indwelling Needles (identical Khanh Phong adhesive patches with the microneedle tip completely removed to prevent skin penetration) applied at the exact same 7 unilateral auricular acupoints: Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7), and Triple Energizer (CO17) following the same 2-cycle schedule (Right ear Days 0-5; Left ear Days 7-12) and manual pressing instructions (at least 3 times daily for 1 minute each time). Receives: Device: Sham Auricular Indwelling Needles; Drug: Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anal Pain or Discomfort During Defecation Assessed by Visual Analogue Scale (VAS)
Self-reported intensity of anal pain or discomfort experienced during defecation, measured using a continuous 100-mm (10-cm) horizontal Visual Analogue Scale (VAS) ranging from 0 ('no anal discomfort or pain') to 10 ('worst imaginable pain'). Higher scores indicate more severe anal pain or discomfort.
Measured: Baseline (Day 0), Day 7, and Day 14
Secondary outcomes (5)
Proportion of Bowel Movements With Bright Red Rectal Bleeding
Calculated for each assessment period as the number of bowel movements accompanied by bright red rectal bleeding divided by the total number of bowel movements recorded in the participant's daily defecation diary, expressed as a ratio/percentage ranging from 0% to 100%. Higher values indicate a higher frequency of defecation-related bleeding.
Measured: Baseline (Day 0), Day 7 (covering Week 1), and Day 14 (covering Week 2)
Severity Grade of Bright Red Rectal Bleeding During Defecation
Assessed using a 4-point ordinal symptom severity scale: Grade 0 (None: no bleeding), Grade 1 (Mild: blood streaks on toilet paper or detected only upon touching the anus), Grade 2 (Moderate: dripping blood clearly visible in the toilet bowl or coating the stool, associated with straining), and Grade 3 (Severe: jet-like or squirting bleeding filling the toilet bowl). Higher grades indicate worse bleeding severity.
Measured: Baseline (Day 0), Day 7, and Day 14
Severity Grade of Internal Hemorrhoidal Prolapse During Defecation (Goligher Classification)
Assessed using the 4-grade ordinal Goligher classification scale during defecation or straining: Grade I (No prolapse outside the anal canal), Grade II (Hemorrhoidal cushions prolapse during defecation or straining but reduce spontaneously), Grade III (Hemorrhoidal cushions prolapse during defecation or straining and require manual reduction), and Grade IV (Permanently prolapsed and irreducible). Higher grades indicate more severe hemorrhoidal prolapse.
Measured: Baseline (Day 0), Day 7, and Day 14
Change in Health-Related Quality of Life Assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Utility Score
Health-related quality of life assessed across 5 dimensions-Mobility (MO), Self-Care (SC), Usual Activities (UA), Pain/Discomfort (PD), and Anxiety/Depression (AD)-each rated on 5 severity levels (Level 1 = no problems to Level 5 = extreme problems/unable to perform). The resulting 5-digit health state profile is converted into a single summary index utility score using the validated Vietnam EQ-5D-5L value set (Mai et al., 2020), where 1.0000 represents full health (11111) and lower scores indicate worse health-related quality of life.
Measured: Baseline (Day 0) and Day 14
Incidence of Treatment-Emergent Adverse Events Related to Auricular Press Needles and Oral Diosmin/Hesperidin
Number and percentage of participants experiencing any treatment-emergent adverse events (TEAEs) recorded via clinical observation and patient self-report, categorized into: (1) Auricular press needle-related events: acupuncture syncope/vasovagal reaction (dizziness, hypotension, diaphoresis), intolerable local ear pain requiring needle removal, local auricular inflammation or infection (redness, swelling, heat, pain, or cellulitis), and local bleeding at the acupoint upon needle removal; and (2) Oral Daflon-related events: gastrointestinal symptoms (dyspepsia, epigastric pain, nausea, vomiting) and non-gastrointestinal events (urticaria, rash).
Measured: From Baseline (Day 0) through Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start20 Nov 2026 (estimated)
- Primary completion10 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Internal HaemorrhoidsStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized, Parallel, Single-Blinded, Sham-Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Le Van Thinh Hospital
- Responsible party
- Principal investigator, Tu Do Quoc, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Deputy principal, Study chair, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07899229
- Sponsor's protocol ID
- 4775/QĐ-ĐHYD
- Acronym
- AIN-MPFF
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Zhang L, Kang L, Li G, Zhang X, Ren J, Shi Z, Li J, Yu S. Computed tomography-based radiomics model for discriminating the risk stratification of gastrointestinal stromal tumors. Radiol Med. 2020 May;125(5):465-473. doi: 10.1007/s11547-020-01138-6. Epub 2020 Feb 11.
PubMed 32048155Chen Y, Chan YH, Chung HY, Wu MZ, Yu YJ, Pi KL, Lau CS, Tse HF, Yiu KH. Cardiovascular events prediction by left ventricular longitudinal strain and serum high-sensitivity troponin I in patients with axial spondyloarthritis. Clin Rheumatol. 2020 Nov;39(11):3373-3382. doi: 10.1007/s10067-020-05112-5. Epub 2020 May 13.
PubMed 32406000Hawkins AT, Davis BR, Bhama AR, Fang SH, Dawes AJ, Feingold DL, Lightner AL, Paquette IM; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2024 May 1;67(5):614-623. doi: 10.1097/DCR.0000000000003276. Epub 2024 Jan 31. No abstract available.
PubMed 38294832Jacobs D. Clinical practice. Hemorrhoids. N Engl J Med. 2014 Sep 4;371(10):944-51. doi: 10.1056/NEJMcp1204188. No abstract available.
PubMed 25184866Fraile L, Vidal A, Romero J, Abella G, Gracia J, Blanco-Penedo I, Pena RN. Validation of a phenotyping method to identify porcine reproductive and respiratory syndrome virus-resilient sows and its impact on sow stayability. J Anim Sci. 2024 Jan 3;102:skae232. doi: 10.1093/jas/skae232.
PubMed 39132682
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Auricular Indwelling Needles as an Adjunct to Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin) in Goligher Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome: A Randomized, Participant-Blind, Sham-Controlled Trial
- ClinicalTrials.gov ID
- NCT07899229
- Acronym / sponsor ID
- AIN-MPFF / 4775/QĐ-ĐHYD
- Conditions
- Internal Haemorrhoids
- Keywords
- Hemorrhoids, Auricular acupuncture, Auricular indwelling needle, Micronized purified flavonoid fraction, Diosmin, Hesperidin, Traditional medicine, Heat-toxin syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- Le Van Thinh Hospital
- Study start
- 20 Nov 2026 (estimated)
- Primary completion
- 10 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 27 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if adding small ear needles to a standard oral medicine can ease symptoms in adults with early-stage internal hemorrhoids (swollen blood vessels inside the anus, grade I-II) who also have the "heat-toxin syndrome" of traditional medicine. In this pattern, people typically have bright red bleeding when passing stool, a burning feeling in the anus, dry stool, dark yellow urine, a dry throat with a bitter taste, a red tongue with a greasy yellow coating, and a rapid pulse. The trial will also learn about the safety of the ear needles.
The main questions it aims to answer are:
Does adding ear needles to the standard medicine lower anal discomfort or pain during bowel movements after 14 days? Does it also reduce bleeding and prolapse (hemorrhoids that come out of the anus) and improve quality of life? What side effects do participants have with the ear needles and with the medicine?
Researchers will compare two groups to see if the ear needles help beyond the standard medicine alone. One group will receive ear needles and the other will receive look-alike ear patches with the needle removed (a "sham" treatment, used so that participants cannot tell which treatment they received). Both groups will take the same medicine, diosmin/hesperidin (Daflon 500 mg), and receive the same diet and lifestyle advice.
Participants will:
Take Daflon 500 mg tablets for 14 days Have ear needles or sham patches placed on seven points of one ear on Day 0 and Day 7 (switching ears each time), and have them removed on Day 5 and Day 12 Press the needles or patches gently at least 3 times a day for 1 minute each time Visit the clinic on Day 0, Day 7 and Day 14 to report their pain (on a 0-10 scale), bleeding and prolapse, and to complete a quality-of-life questionnaire (Day 0 and Day 14) Report any side effects to the study team
Detailed description
Rationale. MPFF improves venous tone and is a standard conservative treatment, yet residual anal discomfort or pain is common and affects quality of life. Auricular points related to the anorectal region may relieve pain and bleeding through neuromodulation. In traditional medicine, a large share of patients with internal hemorrhoids present with the heat-toxin syndrome. Auricular indwelling needles provide continuous stimulation with low invasiveness, but controlled evidence in this population is limited.
Objectives. To compare auricular indwelling needles plus MPFF with sham patches plus MPFF in adults with Goligher grade I-II internal hemorrhoids and the heat-toxin syndrome, regarding (1) anal discomfort/pain during defecation (VAS) at Day 7 and Day 14; (2) bright red bleeding and prolapse at Day 7 and Day 14; (3) quality of life (EQ-5D-5L) at Day 14; (4) adverse events during 14 days.
Design and setting. Randomized, participant-blinded, sham-controlled, two-arm parallel trial at the outpatient clinics of Le Van Thinh Hospital, Ho Chi Minh City, Vietnam. A surgeon confirms internal hemorrhoids of Goligher grade I-II. A traditional medicine physician confirms the heat-toxin syndrome using the criteria in the eligibility section, adapted from the Vietnam Ministry of Health guideline (2020) and the Chinese hemorrhoid guideline of the Chinese Association of Integrative Medicine (2020). Participants give written informed consent.
Randomization and blinding. The allocation sequence (1:1, simple randomization) was generated before enrollment with the RAND function of Microsoft Excel. Group codes are kept in sequentially numbered, sealed, opaque envelopes, opened by the treating physician only after eligibility is confirmed and consent is signed. Participants are told only their group letter (A or B) and are not told how the groups differ. The treating physician cannot be blinded.
Interventions. Both groups: MPFF (Daflon 500 mg; diosmin 450 mg and hesperidin 50 mg per tablet) for 14 days (3 tablets twice daily for 4 days, 2 tablets twice daily for 3 days, then 1 tablet twice daily for 7 days), plus advice on a high-fiber diet, adequate fluids, avoiding spicy food, alcohol and tobacco, and avoiding prolonged sitting or standing. Experimental group: Khanh Phong auricular indwelling needles (0.22 x 1.3 mm) at seven points: Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7) and Sanjiao (CO17), one ear per session, alternating ears (right ear first). Session 1 runs from Day 0 to Day 5 and session 2 from Day 7 to Day 12, with a 2-day ear-free interval. Participants press the needles at least 3 times daily for 1 minute. Sham group: identical patches with the needle removed, applied at the same points, on the same schedule and with the same instructions.
Assessments. VAS, bleeding grade and prolapse grade at Day 0, Day 7 and Day 14; EQ-5D-5L at Day 0 and Day 14; adverse events throughout the 14 days.
Sample size. Calculated for a two-group comparison of means for the VAS change (two-sided alpha 0.05, power 80%), assuming a between-group difference of 1.73 points (Cohen's d = 0.75) and SD 2.31, giving 28 participants per group. A 10% allowance gives 32 per group (64 in total).
Statistical analysis. Stata 17. Continuous variables: mean (SD) or median (IQR). Categorical variables: n (%). Between-group comparisons: t-test or Mann-Whitney U test for continuous and ordinal data, chi-square or Fisher's exact test for categorical data. Within-group changes: paired t-test or Wilcoxon signed-rank test.
Safety and discontinuation. Needle fainting, local inflammation, intolerable pain and bleeding at the needle site are managed according to the Vietnam Ministry of Health acupuncture procedures. Participants who develop heavy rectal bleeding or other emergency signs have the needles removed and are referred to the hospital's surgical or emergency department; serious events are reported to the ethics committee within 24 hours. Participants are withdrawn if they decide to stop, develop serious allergy or complications, or start other hemorrhoid treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A Randomized, Parallel, Single-Blinded, Sham-Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Auricular Indwelling Needles Plus Micronized Purified Flavonoid Fraction (Group A) | Experimental | Device: Auricular Indwelling Needles, Drug: Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin)Participants receive standard conservative therapy including dietary/lifestyle counseling and oral Micronized Purified Flavonoid Fraction (Daflon 500 mg: Diosmin 450 mg + Hesperidin 50 mg) for 14 days (3 tablets twice daily for Days 1-4, 2 tablets twice daily for Days 5-7, and 1 tablet twice daily for Days 8-14), combined with Real Auricular Indwelling Needles (0.22 x 1.3 mm) inserted at 7 unilateral auricular acupoints: Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7), and Triple Energizer (CO17). Needles are applied in 2 cycles: Cycle 1 on the right ear from Day 0 to Day 5 (retained for 5 days, followed by a 2-day rest period), and Cycle 2 on the left ear from Day 7 to Day 12 (retained for 5 days). Participants manually press the needles at least 3 times daily for 1 minute each time. |
| Sham Auricular Indwelling Needles Plus Micronized Purified Flavonoid Fraction (Group B) | Sham comparator | Device: Sham Auricular Indwelling Needles, Drug: Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin)Participants receive the exact same standard conservative therapy including dietary/lifestyle counseling and oral Micronized Purified Flavonoid Fraction (Daflon 500 mg: Diosmin 450 mg + Hesperidin 50 mg) for 14 days (3 tablets twice daily for Days 1-4, 2 tablets twice daily for Days 5-7, and 1 tablet twice daily for Days 8-14), combined with Sham Auricular Indwelling Needles (identical Khanh Phong adhesive patches with the microneedle tip completely removed to prevent skin penetration) applied at the exact same 7 unilateral auricular acupoints: Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7), and Triple Energizer (CO17) following the same 2-cycle schedule (Right ear Days 0-5; Left ear Days 7-12) and manual pressing instructions (at least 3 times daily for 1 minute each time). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female outpatients aged 18 years or older attending Le Van Thinh Hospital.
- Confirmed diagnosis of Grade I or Grade II internal hemorrhoids according to the Goligher classification (based on the 2020 Vietnam Ministry of Health Guidelines and the 2024 American Society of Colon and Rectal Surgeons [ASCRS] Clinical Practice Guidelines), verified by clinical examination and rigid anoscopy.
- Presence of both of the following clinical symptom thresholds at baseline:
- Confirmed diagnosis of Traditional Medicine Heat-Toxicity Syndrome (Hoi chung Nhiet doc, per the 2020 Vietnam Ministry of Health Guidelines and the 2020 Chinese Association of Integrative Medicine Guidelines for Hemorrhoids), requiring fulfillment of all three of the following conditions:
- Naive to auricular press needle therapy (never previously treated with auricular press needles).
Key exclusion criteria (8 listed)
- Indication for surgical hemorrhoidectomy or urgent procedural intervention, including Grade III or Grade IV internal hemorrhoids, large symptomatic external hemorrhoids, thrombosed hemorrhoids, or strangulated/incarcerated hemorrhoids.
- History or current presence of other colorectal or anal conditions causing hematochezia, including colorectal polyps, colorectal cancer, inflammatory bowel disease (Crohn's disease, ulcerative colitis), diverticulitis, anal fissure, or anal fistula.
- History or presence of cognitive impairment or psychiatric disorders, including bipolar disorder, anxiety disorder, depressive disorder, or schizophrenia.
- Congenital or acquired auricular abnormalities or ear conditions, including unilateral or bilateral congenital microtia/anotia, congenital deafness, auricular chondritis, or active skin infection/dermatitis on the auricle.
- Known hypersensitivity or allergy to metal needles, adhesive tape, or any component of the auricular press needles, severe needle phobia, or a history of acupuncture syncope (needle fainting).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auricular Indwelling NeedlesAlso: Khanh Phong Press Needles, Auricular Press Needles, Tianxie Disposable Press Needles (0.22 x 1.3 mm), Auricular AcupunctureSterile, single-use intradermal auricular press needles (Khanh Phong / Tianxie brand, dimensions 0.22 x 1.3 mm, approved by the Vietnam Ministry of Health under Decision No. 287/BYT-YDCT) are inserted perpendicularly to a depth of 1.3 mm after 70% isopropyl alcohol disinfection at 7 auricular acupoints: Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7), and Triple Energizer (CO17). Treatment consists of 2 cycles over 14 days: Cycle 1 on the right ear (inserted on Day 0, removed on Day 5, followed by a 2-day rest period) and Cycle 2 on the left ear (inserted on Day 7, removed on Day 12). Participants press the plastered acupoints at least 3 times per day for 1 minute per session to elicit mild soreness, warmth, or distension (Deqi sensation). | Device | Auricular Indwelling Needles Plus Micronized Purified Flavonoid Fraction (Group A) |
| Sham Auricular Indwelling NeedlesAlso: on-penetrating Sham Auricular Patches, Placebo Press Needles, Placebo Indwelling NeedlesIdentical adhesive patches (Khanh Phong / Tianxie brand) from which the stainless-steel microneedle tip has been completely removed so that no skin penetration or mechanical needle stimulation occurs. Following 70% isopropyl alcohol disinfection, the sham patches are adhered to the exact same 7 unilateral auricular acupoints-Anus (HX5), Rectum (HX2), Sympathetic (AH6a), Shenmen (TF4), Lung (CO14), Large Intestine (CO7), and Triple Energizer (CO17)-on the right ear for Cycle 1 (Day 0 to Day 5) and the left ear for Cycle 2 (Day 7 to Day 12). Participants are instructed to press the patches at least 3 times per day for 1 minute per session, identical to the active intervention group. | Device | Sham Auricular Indwelling Needles Plus Micronized Purified Flavonoid Fraction (Group B) |
| Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin)Also: Daflon 500 mg, MPFF (Diosmin 450 mg / Hesperidin 50 mg)Oral film-coated tablets containing 500 mg of Micronized Purified Flavonoid Fraction (450 mg micronized Diosmin and 50 mg Hesperidin; Daflon 500 mg, manufactured by Servier, France; Vietnam Drug Administration registration No. 3109/QLD-DK). Administered orally for 14 days per the Vietnam Ministry of Health acute hemorrhoidal regimen (Decision No. 5013/QD-BYT): 3 tablets twice daily (3,000 mg/day) for the first 4 days (Days 1 - 4), followed by 2 tablets twice daily (2,000 mg/day) for the next 3 days (Days 5 - 7), and 1 tablet twice daily (1,000 mg/day) for the subsequent 7 days (Days 8 - 14). All participants also receive standardized dietary and lifestyle counseling (high-fiber diet, 1.5 - 2 L water/day, avoidance of spicy food/alcohol/prolonged sitting or straining). | Drug | Auricular Indwelling Needles Plus Micronized Purified Flavonoid Fraction (Group A), Sham Auricular Indwelling Needles Plus Micronized Purified Flavonoid Fraction (Group B) |
Primary outcome
Change in Anal Pain or Discomfort During Defecation Assessed by Visual Analogue Scale (VAS)
Time frame: Baseline (Day 0), Day 7, and Day 14
Self-reported intensity of anal pain or discomfort experienced during defecation, measured using a continuous 100-mm (10-cm) horizontal Visual Analogue Scale (VAS) ranging from 0 ('no anal discomfort or pain') to 10 ('worst imaginable pain'). Higher scores indicate more severe anal pain or discomfort.
5 secondary outcomes
Proportion of Bowel Movements With Bright Red Rectal Bleeding
Time frame: Baseline (Day 0), Day 7 (covering Week 1), and Day 14 (covering Week 2)
Severity Grade of Bright Red Rectal Bleeding During Defecation
Time frame: Baseline (Day 0), Day 7, and Day 14
Severity Grade of Internal Hemorrhoidal Prolapse During Defecation (Goligher Classification)
Time frame: Baseline (Day 0), Day 7, and Day 14
Change in Health-Related Quality of Life Assessed by the EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index Utility Score
Time frame: Baseline (Day 0) and Day 14
Incidence of Treatment-Emergent Adverse Events Related to Auricular Press Needles and Oral Diosmin/Hesperidin
Time frame: From Baseline (Day 0) through Day 14
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 32048155Zhang L, Kang L, Li G, Zhang X, Ren J, Shi Z, Li J, Yu S. Computed tomography-based radiomics model for discriminating the risk stratification of gastrointestinal stromal tumors. Radiol Med. 2020 May;125(5):465-473. doi: 10.1007/s11547-020-01138-6. Epub 2020 Feb 11.
- Background: PubMed 32406000Chen Y, Chan YH, Chung HY, Wu MZ, Yu YJ, Pi KL, Lau CS, Tse HF, Yiu KH. Cardiovascular events prediction by left ventricular longitudinal strain and serum high-sensitivity troponin I in patients with axial spondyloarthritis. Clin Rheumatol. 2020 Nov;39(11):3373-3382. doi: 10.1007/s10067-020-05112-5. Epub 2020 May 13.
- Background: PubMed 38294832Hawkins AT, Davis BR, Bhama AR, Fang SH, Dawes AJ, Feingold DL, Lightner AL, Paquette IM; Clinical Practice Guidelines Committee of the American Society of Colon and Rectal Surgeons. The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids. Dis Colon Rectum. 2024 May 1;67(5):614-623. doi: 10.1097/DCR.0000000000003276. Epub 2024 Jan 31. No abstract available.
- Background: PubMed 25184866Jacobs D. Clinical practice. Hemorrhoids. N Engl J Med. 2014 Sep 4;371(10):944-51. doi: 10.1056/NEJMcp1204188. No abstract available.
- Background: PubMed 39132682Fraile L, Vidal A, Romero J, Abella G, Gracia J, Blanco-Penedo I, Pena RN. Validation of a phenotyping method to identify porcine reproductive and respiratory syndrome virus-resilient sows and its impact on sow stayability. J Anim Sci. 2024 Jan 3;102:skae232. doi: 10.1093/jas/skae232.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deputy principal study chair
University of Medicine and Pharmacy at Ho Chi Minh City
Questions about this trial
What is this clinical trial studying?
A study testing Auricular Indwelling Needles and Micronized Purified Flavonoid Fraction (Diosmin and Hesperidin) in people with Internal Haemorrhoids, run by University of Medicine and Pharmacy at Ho Chi Minh City.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huy C Ly, PhD (0989974868, lychunghuy@ump.edu.vn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Anal Pain or Discomfort During Defecation Assessed by Visual Analogue Scale (VAS) (time frame: Baseline (Day 0), Day 7, and Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07899229, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.