| CTRI Number |
CTRI/2023/03/050632 [Registered on: 13/03/2023] Trial Registered Prospectively |
| Last Modified On: |
13/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment of tear in anal canal |
|
Scientific Title of Study
|
Double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in improving symptoms of chronic anal fissure in adults |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1288-8815 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pujashree Bhattacharyya |
| Designation |
Postgraduate Trainee |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Materia Medica OPD No PG2 and Dept of Surgery OPD No 5, D N De Homoeopathic Medical College & Hospital, 12 Gobinda Khatick Road Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9874494535 |
| Fax |
|
| Email |
dr.bhattacharyya92@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Soumya Bhattacharyya |
| Designation |
Lecturer |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Materia Medica, 12 Gobinda Khatick Road Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9836998171 |
| Fax |
|
| Email |
soumya.bh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Soumya Bhattacharyya |
| Designation |
Lecturer |
| Affiliation |
D N De Homoeopathic Medical College and Hospital |
| Address |
Dept of Materia Medica, 12 Gobinda Khatick Road Tangra
Kolkata
WEST BENGAL
700046
India |
| Phone |
9836998171 |
| Fax |
|
| Email |
soumya.bh@gmail.com |
|
|
Source of Monetary or Material Support
|
| D N De Homoeopathic Medical College and Hospital, 12, Gobinda khatick Road, Tangra, Kolkata 700046 |
|
|
Primary Sponsor
|
| Name |
D N De Homoeopathic Medical College and Hospital |
| Address |
12, Gobinda Khatick Road, Tangra, Kolkata 700046 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Pujashree Bhattacharyya |
D N De Homoeopathic Medical College and Hospital |
Dept of Materia Medica (OPD No PG2), Dept of Surgery (OPD No 5), Dept of Research (OPD No 10), 12, Gobinda Khatick Road, Tangra, Kolkata 700046
Kolkata
WEST BENGAL |
9874494535
dr.bhattacharyya92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K601||Chronic anal fissure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Identical-looking placebos plus concomitant care |
Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Every subject will receive advice on concomitant care, regarding intake of high fiber diet, adequate fluid, maintenance of regimen and hygienic measures. Consuming tobacco in any form and alcohol will be advised to avoid. Pelvic floor strengthening exercise will be advised. Subjects to be advised to be present for follow-up every two weeks. Duration of therapy: 3 months |
| Intervention |
Individualized homoeopathic medicines in centesimal potencies plus concomitant care |
Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies(cH). Each dose will consist of 4 cane sugar globules no. 40 moistened with the indicated medicine (preserved in 90% v/v ethanol), to be taken orally on clean tongue with empty stomach; dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All the medicines and sundry items will be procured from a Good Manufacturing Practice (GMP) certified firm. Every subject will receive advice on concomitant care regarding intake of high fiber diet, adequate fluid, maintenance of regimen and hygienic measures. Consuming tobacco in any form and alcohol will be advised to avoid. Pelvic floor strengthening exercise will be advised. Subjects will be advised to be present for follow-up every two weeks. Duration of therapy: 3 months. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Cases suffering from chronic anal fissure ICD-10(K60.1), with symptoms persisting for more than 6 weeks.
2. Participants of either sex or transgender.
3. Age between 18 and 65 years.
4. Literate patient; ability to read and write in Bengali and/or English. Illiterate participants will be interviewed by the investigators maintaining adequate privacy to fill up the scale or questionnaires
5. Patients with known but controlled systemic diseases.
6. Patients using topical agents for anal fissure will be included after a washout period of one week, subject to persistence of symptoms and signs of fissures.
7. Patients giving written consent voluntarily to participate. |
|
| ExclusionCriteria |
| Details |
1.Cases suffering from uncontrolled systemic illness or life-threatening infections.
2. Cases already undergoing homoeopathic treatment elsewhere for any chronic purpose within last 6 months.
3. Patients with the habit of tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
4. Previous history of surgical interventions for anal fissure.
5. Diagnosed or suspected cases of rectal malignancies.
6. Pregnancy, puerperium and lactation.
7. Patients with psychiatric diseases.
8. Secondary fissure.
9. Vulnerable population- Unconscious, non-ambulatory, too sick for consultation, differently abled, terminally ill or critically ill patients, mentally incompetent people.
10. Simultaneous participation of any other clinical trial |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The scoring system for anal fissure (REALISE) |
At baseline, every 15 days, up to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anorectal symptom severity and quality of life questionnaire (ARSSQoL)
Measure yourself medical outcome proile (MYMOP-2)
|
Every month, every 15 days, up to 3 months |
|
|
Target Sample Size
|
Total Sample Size="111"
Sample Size from India="111"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/04/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None yet, to be published later |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.bhattacharyya92@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
An anal fissure (AF) is a small break or tear in the skin of the anal canal, which typically runs from below the dentate line to the anal verge, and is usually situated in the posterior midline. AF is a small break or tear in the skin of the anal canal, which typically runs from below the dentate line to the anal verge, and is usually situated in the posterior midline. Anal fissure is one of the most frequent and painful anal disease. It is very painful, because it affects the multilayer squamous epithelium of the anoderm, which is richly innervated by pain fibers. During defecation, the lesion is stretched with consequent painful symptomatology, which can persist for a certain amount of time and be accompanied by slight bleeding. The pain can be so intense as to induce the patient to avoid defecation with consequent hardening of the stool and exacerbation of the problem. Anal fissures are not common in patients older than 65 years, and this age group must be suspected to be associated with other pathologies. The lifetime incidence is calculated to be 11%.Homeopathy may have immense potential to offer in successful treatment in chronic anal fissure, but has remained seriously under-researched till date. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of homoeopathic medicines in the treatment of chronic anal fissure in adults. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 111 adults who are suffering from chronic anal fissure at the outpatient department of D N De Homoeopathic Medical College and Hospital. Assessment will be done by the scoring system for anal fissure (REALISE) [Primary outcome], Anorectal symptom severity and quality of questionnaire (ARQSSoL), and Measure yourself and medical outcome profile (MYMOP-2) [Secondary outcomes], all to be measured every 15 days, up to 3 months. Comparative analysis will be carried out to detect group differences. |