| CTRI Number |
CTRI/2025/01/079674 [Registered on: 28/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathic medicines using LM potency in chronic anal fissure |
|
Scientific Title of Study
|
Role of Homoeopathic Medicines using LM potency in management of chronic anal fissure in age group of 20-60 years assessed by realise score |
| 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 NANCY CHETANBHAI PATEL |
| Designation |
PG SCHOLAR |
| Affiliation |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF SURGERY ROOM NO 13 GROUND FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA
Mahesana
GUJARAT
384001
India |
| Phone |
9429317373 |
| Fax |
|
| Email |
nancypatel5012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAYANK RAVAL |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF ORAGANON OF MEDICINE AND PHILOSOPHY ROOM NO 16 FIRST FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA
Mahesana
GUJARAT
384001
India |
| Phone |
9979133069 |
| Fax |
|
| Email |
ravalmayank3@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NANCY CHETANBHAI PATEL |
| Designation |
PG SCHOLAR |
| Affiliation |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
| Address |
DEPARTMENT OF SURGERY ROOM NO 13 GROUND FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA
Mahesana
GUJARAT
384001
India |
| Phone |
09429317373 |
| Fax |
|
| Email |
nancypatel5012@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA GUJARAT 384001 |
|
|
Primary Sponsor
|
| Name |
DR NANCY CHETANBHAI PATEL |
| Address |
DEPARTMENT OF SURGERY ROOM NO 13 GROUND FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA
GUJARAT 384001 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| DR NANCY CHETANBHAI PATEL |
SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE |
DEPARTMENT OF SURGERY ROOM NO 13 GROUND FLOOR SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESEARCH INSTITUTE PUSHPANJALI BUILDING NEAR DISTRICT SESSION COURT MEHSANA
Mahesana
GUJARAT |
9429317373
nancypatel5012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMT A J SAVLA HOMOEOPATHIC MEDICAL COLLEGE AND RESERCH INSTITUTE INSTITUTIONAL ETHICAL COMMITTEE |
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 |
HOMOEOPATHIC MEDICINES |
POTENCY LM POTENCY
DOSE AS PER NEED OF CASE
FREQENCY AS PER NEED OF CASE
ROUTE OF ADMINISTRATION ORAL
DURATION OF TREATMENT UPTO 6 MONTHS AS PER NEED OF CASE |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
The cases will diagnose according icd 11
Age group 20 TO 60 years
Consent Participants willing to provide informed consent to participate in study
Patients who have complaints of chronic anal fissure more than 6 weeks
The REALISE score is 4 21 |
|
| ExclusionCriteria |
| Details |
Hemorrhoids Fistula ano rectal or Perianal Abscess Crohns disease Ulcerative colitis Diverticulosis Anal or rectal Malignancy colon malignancy Tuberculosis syphilis Hepatitis B Multiple fissures irritable bowel disease AIDs no any major organic pathology
Previous anorectal operations rectal prolapsed polyp in rectum
Congenital anomalies of the anal canal
Patients inability to comply with study protocol(psychiatric disease) or mental behavioural disorders neurodevelopmental disease
Pregnancy and lactating mother
Patients who are taking any mode of treatment like Allopathy Homoeopathy Ayurvedic etc |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| REALISE SCORE TO ASSESS REDUCTION IN SYMPTOMS OF CHRONIC ANAL FISSURE |
SCORE WILL BE ASSESSED AT BASELINE AND AT END OF TRERATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
THIS STUDY IS A PROSPECTIVE STUDY PRE TEST POST TEST SINGLE GROUP EXPERIMENTAL STUDY TO ASSESS THE ROLE OF HOMOEOPATHIC MEDICINES USING LM POTENCY FOR 6 MONTHS IN 40 PARTICIPANTS WITH CHRONIC ANAL FISSURE THAT WILL BE CONDUCTED AS PER INCLUSION AND EXCLUSION CRITERIA FROM OUT PATIENT DEPARTMENT AND OUTCOME MEASURES WILL ASSESS BY REALISE SCORE AND FOLLOW UP AS PER NEED OF CASE AT 15 DAYS UP TO 6 MONTHS OF DURATION |