| 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
|
|
|
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
|
|
|
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. |