Mixed HemorrhoidsPhase 3MBINCT06660680
The Effect of Methylene Blue Infiltrating Injection on Anal Pain After Milligan-Morgan Surgery: A Randomized Controlled Clinical Study
A Phase 3 study testing Methylene Blue in people with Mixed Hemorrhoids, run by The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine at 1 site in China.
Trial summary
A variety of analgesic strategies are available following mixed hemorrhoids surgery, including pharmacological interventions (7), acupuncture, moxibustion, and electroacupuncture . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mixed Hemorrhoids
- What is being tested?
- Methylene Blue
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2024to 1 Oct 2025
- Phase
- Phase 3
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:①Alignment with the diagnostic criteria for mixed hemorrhoids as outlined in the "American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Management of Hemorrhoids" ; ②Provision of informed consent following a thorough comprehension of the study's aims; ③An age bracket of 18 to 75 years; ④Satisfaction of surgical indications.
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Exclusion Criteria:①Presence of anal fistula, anal fissure, perianal abscess, enteritis, or other intestinal pathologies; ②Patients with known allergies; ③Impaired liver or kidney function; ④Pregnancy or lactation.
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Second hospital affiliated Anhui University of Chinese Medicine
Hefei, Anhui, 230000
About this study
Official title: the Ethics Committee of the Second Hospital of Chinese Medicine
A variety of analgesic strategies are available following mixed hemorrhoids surgery, including pharmacological interventions (7), acupuncture, moxibustion, and electroacupuncture . Medications such as opioid analgesics and non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used but can be associated with side effects including nausea, vomiting, and gastrointestinal bleeding, with long-term use potentially leading to addiction (8). Complementary therapies require skilled administration and regular treatment sessions.
Methylene blue (MB), a cationic thiazine dye extensively utilized as a biological stain and chemical indicator, has been increasingly recognized for its potential analgesic properties (9). In the present study, methylene blue infiltrating injection (MBI) was administered to treat anal pain resulting from Milligan-Morgan surgery, with the aim of assessing its analgesic efficacy and safety profile.
- Conditions
- Mixed Hemorrhoids
- Being tested
- Methylene Blue
- Keywords
- Milligan-Morgan surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene BlueDrug
Received MBI treatment to their surgical incisions upon completion of surgery
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | received MBI treatment to their surgical incisions upon completion of surgery Receives: Drug: Methylene Blue |
| Control group | No intervention | administered lornoxicam on an as-needed basis for analgesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Visual Analog Scale (VAS) scores
Measured: pain scores at 6, 24, 48, and 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start25 Oct 2024
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mixed HemorrhoidsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heng Deng, The Second Affiliated Hospital of Anhui University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660680
- Sponsor's protocol ID
- HFBH2021011
- Other IDs
- (No. 2023AH050848)
- Acronym
- MBI
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 28 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anorectal Branch of Chinese Medical Doctor A, Colorectal Surgery Group SSoCMA.