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CTRI Number  CTRI/2025/07/091512 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 22/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   "A study to find out how well some less commonly used homoeopathic medicines work in treating haemorrhoids" 
Scientific Title of Study   Efficacy Of Lesser Known Homoeopathic Medicines In Treatment Of Haemorrhoids – A Clinical Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Disha Kumari Ratilal Patel 
Designation  MD scholar Part 2 
Affiliation  S. S. Agrawal Homoeopathic Medical College And General Hospital , Navsari 
Address  Near Devina Park Society Gandevi Road Navsari Gujarat 396445 PG Division , 5th floor Homoeopathic Materia Medica Department

Navsari
GUJARAT
396445
India 
Phone  9898035690  
Fax    
Email  pdisha765@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. NehaPatel 
Designation  Associate Professor of Homoeopathic Materia Medica 
Affiliation  S. S. Agrawal Homoeopathic Medical College And General Hospital , Navsari 
Address  Near Devina Park Society, Gandevi Road, Navsari, Gujarat 396445 PG division , 5th floor Homoeopathic Materia Medica Department

Navsari
GUJARAT
396445
India 
Phone  7698584746  
Fax    
Email  nehapatel.12792@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Neha Patel 
Designation  Associate Professor of Homoeopathic Materia Medica 
Affiliation  S. S. Agrawal Homoeopathic Medical College And General Hospital , Navsari 
Address  Near Devina Park Society, Gandevi Road, Navsari, Gujarat 396445 PG Division, 5th floor Homoeopathic Materia Medica Department

Navsari
GUJARAT
396445
India 
Phone  7698584746  
Fax    
Email  nehapatel.12792@gmail.com  
 
Source of Monetary or Material Support  
S S Agrawal Homoeopathic Medical College and General Hospital, Navsari 
 
Primary Sponsor  
Name  S S Agrawal Homoeopathic Medical College and General Hospital 
Address  Near Devina Park Society, Gandevi Road, Navsari, 396445 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Disha Kumari Ratilal Patel  S S Agrawal Homoeopathic Medical College and General Hospital, Navsari, Surgery Opd, Ground Floor  Near Devina Park Society, Gandevi Road, Navsari, Gujarat 396445
Navsari
GUJARAT 
9898035690

pdisha765@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTION ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K649||Unspecified hemorrhoids,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Homoeopathic Medicine:Aegle folia, Gratiola officinalis, Mancinella, Strontium carbonicum   Homoeopathic medicines Aegle folia, Gratiola officinalis, Mancinella, Strontium carbonicum will be prescribe on the basis of individual totality of symptoms. The dose and potency will be selected on the basis of patient susceptibility and necessity of case. administration will be through oral route and follow up will be taken in every 2-3 weeks.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Both sexes and all types of socio economical status.
2.Diagnostic criteria are mainly based on the clinical presentation.
3.Diagnosed cases of Haemorrhoids, taking treatment from other system of medicine and in homoeopathy treatment only those cases will be included where the treatment given with the four homoeopathic medicine being studied, feeling no relief or recurrence or under control but seeking Homoeopathic treatment.
 
 
ExclusionCriteria 
Details  1.Patients of age group below 15 years and above 65 years.
2.Pregnant women
3.Cases with complication like heavy bleeding , fissure in ano , fistula in ano , malignancy , crohn’s disease , ulcerative colitis and other diseases having rectal complaints secondary phenomena are excluded.
4.Patients having other severe systemic disorders .
5.The cases, who do not continue with treatment up to six visits, were dropped out of the study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of lesser known homoeopathic medicines in treatment of haemorrhoids.   9 Months 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the symptomatic relief before and after treatment with the help of Haemorrhoid Symptom severity scale.  9 Months 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   02/08/2025 
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="0"
Months="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 clinical study titled “Efficacy of Lesser Known Homoeopathic Medicines in the Treatment of Haemorrhoids – A Clinical Study” aims to evaluate the effectiveness of lesser-known homoeopathic medicines—Aegle folia, Gratiola officinalis, Mancinella, and Strontium carbonicum—in the treatment of haemorrhoids. It is a prospective, interventional, open-label, single-arm clinical trial, where all participants will receive one of the selected homoeopathic remedies based on individualization and symptom totality. The study will be conducted on 80 patients, aged 15 to 65 years, of either gender, who are clinically diagnosed with internal or external haemorrhoids and are willing to undergo homoeopathic treatment. Patients requiring emergency surgery, pregnant/lactating women, or those under malignant disease condition  will be excluded. The primary outcome will be measured using the Haemorrhoid Symptom Severity Scale (HSSS) before and after treatment. Secondary objectives include assessing incidence by age, sex, occupation, identifying the most effective medicine among the selected ones. The study will span nine months, including recruitment, treatment, and follow-up phases. The site of study will be S S AGRAWAL  Homoeopathic Medical College and General Hospital OPD at Navsari. The trial has received ethical approval from the Institutional Ethics Committee. The study is led by Dr. Disha Patel , a Postgraduate Scholar from the Department of Homoeopathic Materia Medica.

 
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