Biliary ColicNCT07194655
Study on the Immediate Analgesic Effect of Yanglingquan Acupoint Treatment for Biliary Colic
A study testing Acupuncture at the Yanglingquan point, Acupuncture at the Xiabai Point and Acupuncture at non-meridian points in people with Biliary Colic, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine.
Trial summary
Guided by traditional meridian and acupoint theory, conducting standardized, large-sample, multicenter randomized controlled trials (RCTs) to evaluate the clinical efficacy of pattern differentiation and meridian-based acupoint selection for biliary colic across multiple levels can provide high-quality research… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Biliary Colic
- What is being tested?
- Acupuncture at the Yanglingquan point, Acupuncture at the Xiabai Point and Acupuncture at non-meridian points
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 248 participants
- Where
- No sites listed yet
- Study dates
- Oct 2025to Oct 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meets diagnostic criteria for cholecystitis according to both Chinese and Western medicine;
- Patients exhibiting clinical manifestations of biliary colic with a Visual Analogue Scale (VAS) score >4;
- Aged 18 to 65 years;
- Patients provide informed consent and voluntarily participate in this study.
Who cannot join
- Patients meeting criteria for emergency surgery;
- Patients with psychiatric issues unable to cooperate with treatment;
- Patients with severe complications such as suppurative cholecystitis, suppurative cholangitis, acute pancreatitis, gallbladder perforation, tumors, or severe infections;
- Patients with other serious comorbidities including liver, brain, kidney, or cardiovascular diseases;
- Patients with severe local lesions (e.g., infections, burns, scalds) where acupuncture is contraindicated;
- Pregnant women and lactating women;
- Patients who have already undergone other treatment modalities.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Jiawen Dong contact
About this study
Guided by traditional meridian and acupoint theory, conducting standardized, large-sample, multicenter randomized controlled trials (RCTs) to evaluate the clinical efficacy of pattern differentiation and meridian-based acupoint selection for biliary colic across multiple levels can provide high-quality research evidence for developing evidence-based guidelines or optimal treatment protocols. This holds significant importance for enhancing the clinical efficacy of acupuncture in treating biliary colic and promoting its widespread clinical application. Therefore, this study will conduct a multicenter, large-sample randomized controlled trial comparing the clinical effects of acupuncture at Yanglingquan (GB34) versus drug therapy for acute cholecystitis biliary colic. It aims to investigate the clinical efficacy and safety of acupuncture treatment for acute cholecystitis biliary colic.
- Conditions
- Biliary Colic
- Being tested
- Acupuncture at the Yanglingquan point, Acupuncture at the Xiabai Point, Acupuncture at non-meridian points
- Keywords
- Biliary colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture at the Yanglingquan pointOther
Acupuncture at the Yanglingquan point
Acupuncture at the Xiabai PointOther
Acupuncture at the Xiabai Point
Acupuncture at non-meridian pointsOther
Acupuncture at non-meridian points
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Drug therapy only |
| Acupuncture group A | Experimental | Acupuncture at the Yanglingquan point Receives: Other: Acupuncture at the Yanglingquan point |
| Acupuncture group B | Experimental | Acupuncture at the Xiabai Point Receives: Other: Acupuncture at the Xiabai Point |
| Acupuncture group C | Sham comparator | Acupuncture at non-meridian points Receives: Other: Acupuncture at non-meridian points |
What is being measured
The primary outcome is the main question the study is designed to answer.
Simplified McGill Pain Questionnaire (SF-MPQ) Score：Visual Analogue Scale (VAS)
This is a simple, single-dimensional method for measuring pain intensity, which consists of a 10-centimeter horizontal line. The left end is marked with "No pain", and the right end is marked with "most severe pain". The patient marks a point on the line representing the current intensity of their pain.The higher the score, the worse the result.
Measured: One week from enrollment to the end of treatment
Simplified McGill Pain Questionnaire (SF-MPQ) Score：Pain Index (PRI)
It contains 15 pain description words, which are divided into two categories: sensory items (11 words) : throbbing pain, shooting pain, stabbing pain, sharp pain, spastic pain, biting pain, heat-burning pain, aching pain, heavy pain, touch pain, tearing pain. Emotional items (4 words) : Tiredness - feeling exhausted, nauseating, fear, punishment - feeling tormented. PRI scoring criteria: 0 = None; 1= mild; 2= moderate; 3= Severe. Calculate the total score. The higher the score, the worse the result.
Measured: One week from enrollment to the end of treatment
Simplified McGill Pain Questionnaire (SF-MPQ) Score-Current Pain Intensity (PPI)
This is a single overall score for the current intensity of pain. It adopts a 5-point scoring method: 0= painless; 1= Mild pain; 2= uncomfortable pain; 3= Distress pain; 4= Terrifying pain; 5= Extreme pain. The higher the score, the worse the result.
Measured: One week from enrollment to the end of treatment
Gallstones Traditional Chinese Medicine Syndrome Scoring
Referring to the relevant content of the "Clinical Guidelines for New Traditional Chinese Medicine Drugs (Trial)" 2002 edition "Gallstones" chapter, a quantitative scoring table for TCM syndromes was formulated. This study scored three symptoms: right upper abdominal pain, tenderness in the gallbladder area, and nausea and vomiting. The main symptoms (pain type) were scored as 0 points, 3 points, 6 points, and 9 points respectively for asymptomatic, mild symptoms, moderate symptoms, and severe symptoms. For secondary symptoms (nausea and vomiting), scores of 0, 1, 2, and 3 are given based on the above conditions. The minimum value is 0 points and the maximum value is 12 points.The scoring time is before treatment and 12 hours after treatment.The higher the score, the worse the result.
Measured: One week from enrollment to the end of treatment
Secondary outcomes (4)
Biliary tract ultrasound
Maximum longitudinal diameter (L) and anterior-posterior diameter (W) of the gallbladder
Measured: One week from enrollment to the end of treatment
The levels of plasma C-reactive protein (CRP)
The levels of plasma C-reactive protein (CRP)were detected before the start of treatment and 30 minutes after treatment.The measurement unit is mg/L.
Measured: One week from enrollment to the end of treatment
The levels of plasma cholecystokinin (CCK)
The levels of plasma cholecystokinin (CCK) were detected before the start of treatment and 30 minutes after treatment.The measurement unit is pmol/L.
Measured: One week from enrollment to the end of treatment
The levels of plasma β -endorphin (β-EP)
The levels of plasma β -endorphin (β-EP) were detected before the start of treatment and 30 minutes after treatment.The measurement unit is pg/mL.
Measured: One week from enrollment to the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Biliary ColicStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, Tianjin Hospital of Integrated Traditional Chinese and Western Medicine
- Responsible party
- Principal investigator, Jiawen Dong, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194655
- Sponsor's protocol ID
- NKYY_YX_IRB_SOP_016(F）_002_04
- Status last verified
- Sep 2025
- First submitted
- 16 Sep 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhou Y, Shen Y, Ye X, He D, Sun N, Zhang Y, Zhang Y, Long C, Ding S, Deng L, Deng Y, Liang F, Gong X, Sun R. Acupuncture on GB34 for immediate analgesia and regulating pain-related anxiety for patients with biliary colic: a protocol of randomized controlled trial. BMC Complement Med Ther. 2023 Jul 7;23(1):224. doi: 10.1186/s12906-023-04030-8.
PubMed 37420212Patel R, Tse JR, Shen L, Bingham DB, Kamaya A. Improving Diagnosis of Acute Cholecystitis with US: New Paradigms. Radiographics. 2024 Dec;44(12):e240032. doi: 10.1148/rg.240032.
PubMed 39541246
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Immediate Analgesic Effect of Yanglingquan Acupoint Treatment for Biliary Colic
- ClinicalTrials.gov ID
- NCT07194655
- Acronym / sponsor ID
- NKYY_YX_IRB_SOP_016(F）_002_04
- Conditions
- Biliary Colic
- Keywords
- Biliary colic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- First Teaching Hospital of Tianjin University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Tianjin Medical University General Hospital, Tianjin Hospital of Integrated Traditional Chinese and Western Medicine
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 26 Sep 2025 (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.
Guided by traditional meridian and acupoint theory, conducting standardized, large-sample, multicenter randomized controlled trials (RCTs) to evaluate the clinical efficacy of pattern differentiation and meridian-based acupoint selection for biliary colic across multiple levels can provide high-quality research evidence for developing evidence-based guidelines or optimal treatment protocols. This holds significant importance for enhancing the clinical efficacy of acupuncture in treating biliary colic and promoting its widespread clinical application. Therefore, this study will conduct a multicenter, large-sample randomized controlled trial comparing the clinical effects of acupuncture at Yanglingquan (GB34) versus drug therapy for acute cholecystitis biliary colic. It aims to investigate the clinical efficacy and safety of acupuncture treatment for acute cholecystitis biliary colic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Drug therapy only |
| Acupuncture group A | Experimental | Other: Acupuncture at the Yanglingquan pointAcupuncture at the Yanglingquan point |
| Acupuncture group B | Experimental | Other: Acupuncture at the Xiabai PointAcupuncture at the Xiabai Point |
| Acupuncture group C | Sham comparator | Other: Acupuncture at non-meridian pointsAcupuncture at non-meridian points |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets diagnostic criteria for cholecystitis according to both Chinese and Western medicine;
- Patients exhibiting clinical manifestations of biliary colic with a Visual Analogue Scale (VAS) score >4;
- Aged 18 to 65 years;
- Patients provide informed consent and voluntarily participate in this study.
Key exclusion criteria (7 listed)
- Patients meeting criteria for emergency surgery;
- Patients with psychiatric issues unable to cooperate with treatment;
- Patients with severe complications such as suppurative cholecystitis, suppurative cholangitis, acute pancreatitis, gallbladder perforation, tumors, or severe infections;
- Patients with other serious comorbidities including liver, brain, kidney, or cardiovascular diseases;
- Patients with severe local lesions (e.g., infections, burns, scalds) where acupuncture is contraindicated;
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 |
|---|---|---|
| Acupuncture at the Yanglingquan pointAcupuncture at the Yanglingquan point | Other | Acupuncture group A |
| Acupuncture at the Xiabai PointAcupuncture at the Xiabai Point | Other | Acupuncture group B |
| Acupuncture at non-meridian pointsAcupuncture at non-meridian points | Other | Acupuncture group C |
Primary outcome
Simplified McGill Pain Questionnaire (SF-MPQ) Score：Visual Analogue Scale (VAS)
Time frame: One week from enrollment to the end of treatment
This is a simple, single-dimensional method for measuring pain intensity, which consists of a 10-centimeter horizontal line. The left end is marked with "No pain", and the right end is marked with "most severe pain". The patient marks a point on the line representing the current intensity of their pain.The higher the score, the worse the result.
Simplified McGill Pain Questionnaire (SF-MPQ) Score：Pain Index (PRI)
Time frame: One week from enrollment to the end of treatment
It contains 15 pain description words, which are divided into two categories: sensory items (11 words) : throbbing pain, shooting pain, stabbing pain, sharp pain, spastic pain, biting pain, heat-burning pain, aching pain, heavy pain, touch pain, tearing pain. Emotional items (4 words) : Tiredness - feeling exhausted, nauseating, fear, punishment - feeling tormented. PRI scoring criteria: 0 = None; 1= mild; 2= moderate; 3= Severe. Calculate the total score. The higher the score, the worse the result.
Simplified McGill Pain Questionnaire (SF-MPQ) Score-Current Pain Intensity (PPI)
Time frame: One week from enrollment to the end of treatment
This is a single overall score for the current intensity of pain. It adopts a 5-point scoring method: 0= painless; 1= Mild pain; 2= uncomfortable pain; 3= Distress pain; 4= Terrifying pain; 5= Extreme pain. The higher the score, the worse the result.
Gallstones Traditional Chinese Medicine Syndrome Scoring
Time frame: One week from enrollment to the end of treatment
Referring to the relevant content of the "Clinical Guidelines for New Traditional Chinese Medicine Drugs (Trial)" 2002 edition "Gallstones" chapter, a quantitative scoring table for TCM syndromes was formulated. This study scored three symptoms: right upper abdominal pain, tenderness in the gallbladder area, and nausea and vomiting. The main symptoms (pain type) were scored as 0 points, 3 points, 6 points, and 9 points respectively for asymptomatic, mild symptoms, moderate symptoms, and severe symptoms. For secondary symptoms (nausea and vomiting), scores of 0, 1, 2, and 3 are given based on the above conditions. The minimum value is 0 points and the maximum value is 12 points.The scoring time is before treatment and 12 hours after treatment.The higher the score, the worse the result.
4 secondary outcomes
Biliary tract ultrasound
Time frame: One week from enrollment to the end of treatment
The levels of plasma C-reactive protein (CRP)
Time frame: One week from enrollment to the end of treatment
The levels of plasma cholecystokinin (CCK)
Time frame: One week from enrollment to the end of treatment
The levels of plasma β -endorphin (β-EP)
Time frame: One week from enrollment to the end of treatment
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 26 Sep 2025.
- Background: PubMed 37420212Zhou Y, Shen Y, Ye X, He D, Sun N, Zhang Y, Zhang Y, Long C, Ding S, Deng L, Deng Y, Liang F, Gong X, Sun R. Acupuncture on GB34 for immediate analgesia and regulating pain-related anxiety for patients with biliary colic: a protocol of randomized controlled trial. BMC Complement Med Ther. 2023 Jul 7;23(1):224. doi: 10.1186/s12906-023-04030-8.
- Background: PubMed 39541246Patel R, Tse JR, Shen L, Bingham DB, Kamaya A. Improving Diagnosis of Acute Cholecystitis with US: New Paradigms. Radiographics. 2024 Dec;44(12):e240032. doi: 10.1148/rg.240032.
- Individual participant dataSharing planned: No
Related trials for Biliary Colic
Active, not recruiting
RELIEF-pathway in Patients With Upper Abdominal Pain
Abdominal Pain, Gallstone; Colic
Not yet recruiting
EUS-Guided Gallbladder Drainage Versus Conservative Management in Patients Unfit for Surgery After a Biliary Event Without Cholecystitis. DRECON Study
Cholecystectomy, Gallbladder
Recruiting
One vs. Two Stents for Gallbladder Disease
Recurrent Cholecystitis, Cholecystitis
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.
Jiawen Dong contact
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture at the Yanglingquan point, Acupuncture at the Xiabai Point and Acupuncture at non-meridian points in people with Biliary Colic, run by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine.
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 4 inclusion and 7 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 26 Sep 2025. 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 JING Li (86-022-18920351627, 1725155193@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Simplified McGill Pain Questionnaire (SF-MPQ) Score：Visual Analogue Scale (VAS) (time frame: One week from enrollment to the end of treatment). The study lists 4 primary outcomes in all. 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 NCT07194655, which also lists 2 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 26 Sep 2025.