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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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