| CTRI Number |
CTRI/2024/11/076641 [Registered on: 11/11/2024] Trial Registered Prospectively |
| Last Modified On: |
16/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathy in Anal Fissures |
|
Scientific Title of Study
|
Efficacy of homoeopathic medicines in the treatment of primary chronic anal fissures: A multicentric, double-blinded, randomized placebo-controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Baidurjya Bhattacharjee |
| Designation |
Research Officer (Homoeopathy) Scientist- 1 |
| Affiliation |
Regional Research Institute for Homoeopathy, Siliguri |
| Address |
Regional Research Institute for Homoeopathy Siliguri
Room no. 107
Department of Clinical Research
Chhotapathuramjote Opp The Art of Living Ashram
Darjiling WEST BENGAL 734012 India |
| Phone |
9239297736 |
| Fax |
|
| Email |
baibhms@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Baidurjya Bhattacharjee |
| Designation |
Research Officer (Homoeopathy) Scientist- 1 |
| Affiliation |
Regional Research Institute for Homoeopathy, Siliguri |
| Address |
Regional Research Institute for Homoeopathy Siliguri
Room no. 107
Department of Clinical Research
Chhotapathuramjote Opp The Art of Living Ashram
WEST BENGAL 734012 India |
| Phone |
9239297736 |
| Fax |
|
| Email |
baibhms@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Varanasi Roja |
| Designation |
Research Officer (Homoeopathy) Scientist 3 |
| Affiliation |
Central Council for Research in Homoeopathy |
| Address |
Central Council for Research in Homoeopathy
Room no 317
Department of Clinical Research
61-65 Institutional Area, Opp D block Janakpuri Central Council for Research in Homoeopathy
61-65 Institutional Area, Opp D block Janakpuri South West DELHI 110058 India |
| Phone |
09999454036 |
| Fax |
|
| Email |
varanasiroja@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Homoeopathy
Ministry of Ayush, Govt of India
61-65 Industrial Area, Opp D Block, Janakpuri
New Delhi, India, Pin 110058 |
|
|
Primary Sponsor
|
| Name |
Dr Subhash Kaushik Director General |
| Address |
Central Council for Research in Homoeopathy
61-65 Institutional Area, Opp D block Janakpuri
New Delhi, India, Pin 110058 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr G R C Reddy |
Clinical Research Unit for Homoeopathy Tirupati |
Room No. 1, Department of Clinical Research
Sravanam Campus, Near Rajanna Park, Old Maternity Hospital Road, Tirupati Chittoor ANDHRA PRADESH |
9441208007
dr.grcreddy@gmail.com |
| Dr Shweta Gautam |
Dr D P Rastogi Central Research Institute for Homoeopathy Noida |
Room no. 226, Department of Clinical Research
A-1/1, Sector 24, Noida Gautam Buddha Nagar UTTAR PRADESH |
9999566890
dr.shwetagtm@gmail.com |
| Dr Tejaswini Patole |
Regional Research Institute for Homoeopathy Navi Mumbai |
Room no. 011, OPD 3
Department of Clinical Research
Plot no. 38 and 39, sector 18, Navi Mumbai Pin 410210 Raigarh MAHARASHTRA |
874903395
tejaswini74@gmail.com |
| Dr Baidurjya Bhattacharjee |
Regional Research Institute for Homoeopathy, Siliguri |
Room No. 107, OPD 2
Department of Clinical Research
Chhotapathuramjote, Opp the Art of Living Ashram, Darjeeling Pin 734012 Darjiling WEST BENGAL |
9239297736
baibhms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Central Ethics Committee |
Approved |
| Institutional Ethical Commitee of Dr D P Rastogi Central Research Institute for Homoeopathy Noida |
Approved |
| Institutional Ethics Committee of Regional Research Institute for Homoeopathy Navi Mumbai |
Approved |
| Institutional Ethics Committee of Regional Research Institute for Homoeopathy Siliguri |
Approved |
|
|
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 |
| Intervention |
Individualized Homoeopathic Medicines |
The intervention group shall receive Homoeopathic medicines prescribed by the study investigator. The selection of Homoeopathic medicine shall be based on any of the prescription methods used in Homoeopathy, viz. Repertorial selection, keynote method, the essence of remedy etc. The investigators shall primarily employ individualized methods of selection of remedies. Homoeopathic medicines shall be dispensed in the form of homoeopathic dilutions in 6CH, 30CH, 200CH, 1000CH potencies. The intervention shall be dispensed in 30 no. cane sugar globules by moistening globules with the dilutions. All medicine shall be administered by oral route and 4-5 globules shall constitute a single dose. The dose and repetition of the selected medicine shall be based on the discretion of the prescribing investigator. |
| Comparator Agent |
Placebo |
The comparator shall comprise of 90% v/v ethanol which is very similar in taste, smell and appearance to the intervention agent. The comparator shall be dispensed by moistening 30 no cane guar globules and administered by the oral route. 4-5 moistened globules shall comprise of one dose. The dosage and frequency of repetition is as per the discretion of the investigator. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from clinically diagnosed chronic anal fissures presented with a minimum pain REALISE score of 10
2. Patients with longitudinal anal fissures
3. Age- 18 to 75 years
4. Both sexes
5. Persons suffering from chronic disorders like diabetes mellitus, hypertension, hypercholesteremia, metabolic syndrome, rheumatological disorders, joint disorders, and hypothyroidism are in a stable state elicited by a stable dosage of medicines for such conditions for the last three months.
6. Voluntary informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients with lateral anal fissures with or without rectal or anal carcinoma
2. Patients underwent lateral sphincterotomy or hemorrhoidectomy, or any anal or rectal surgery
3. Patients with self-reported chronic diseases like Tuberculosis, sexually transmitted diseases, HIV-AIDS, and other immune-compromised states.
4. Patients reportedly practicing anal coitus
5. Patients with diagnosed severe psychological disorders like bipolar disorders, Schizophrenia, suicidal disorders, opioid abuse, and severe mania |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REALISE score |
REALISE score at baseline, 3 months, 6 months, 9 months and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Recurrence of anal fissure |
At any point from baseline till end of follow up |
| Occurence of anal incontinence to hard or soft stool |
Any point from baseline to end of follow-up |
| Requirement of anal dilatation under local anesthesia or pain relieving medicines |
Any point from baseline to end of follow-up |
| Drop out of participants in the study groups |
Any point from baseline till end of follow-up |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
02/12/2024 |
| 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="3" Months="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Chronic anal fissure (CAF) is defined as an ulcer that lasts at least six weeks due to chronic hypertonia of the anal sphincters and gets inflamed with scar tissue. Diagnosis is usually made from history and clinical presentation of pain could be a dominant symptom which is very intense in acute fissures but less severe in chronic cases. Often, they are associated with constipation, bleeding and mucous discharge from the anus. The recommended gold standard treatment modality for chronic fissures is lateral internal sphincterotomy (LIS) which often leads to complaints associated with stool continence. Alternatively, Chemical sphincterotomy (CS) with botulinum toxin, nitrates or calcium blockers is also recommended as non-invasive methods but the efficacy of such interventions are not well established. In homoeopathy, no good quality studies have been conducted on this condition to date, therefore this current trial is aimed to find whether empirically used medicines alter the outcome of treatment of chronic primary anal fissure. Homoeopathic medicines are clinically found to be safe and effective for the condition and the same evidence is to be confirmed within this trial. |