| CTRI Number |
CTRI/2026/01/101381 [Registered on: 16/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative Study of Two Homoeopathic Treatment Methods (Mother Tincture and Centesimal Potency) for Hemorrhoids in Adults, Assessing Symptom Improvement |
|
Scientific Title of Study
|
A Comparative Clinical Study Of Centesimal Potency Vs. Mother Tincture In The Homoeopathic Management Of Hemorrhoids Using Hemorrhoid Severity Score In Adults |
| 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 Chandni Pravinbhai Fataniya |
| Designation |
PG scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University |
| Address |
OPD Room number 102
Jawaharlal Nehru Homoeopathic Medical College and Hospital
Waghodia
Vadodara
Gujarat
India
391760
Vadodara GUJARAT 391760 India |
| Phone |
9033415831 |
| Fax |
|
| Email |
chnadnifataniya22@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Partha Sarathi Mandal |
| Designation |
BHMS, MD Homoeopathy, HoD PG Department of Organon of Medicine and Homoeopathic Philosophy |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University |
| Address |
PG Department of Organon of Medicine and Homoeopathic Philosophy
Jawaharlal Nehru Homoeopathic Medical College and Hospital
Waghodia
Vadodara
Gujarat
India
391760
Vadodara GUJARAT 391760 India |
| Phone |
9375095471 |
| Fax |
|
| Email |
partha.mandal27317@paruluniversity.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Chandni Pravinbhai Fataniya |
| Designation |
PG scholar |
| Affiliation |
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University |
| Address |
OPD Room number 102
Jawaharlal Nehru Homoeopathic Medical College and Hospital
Waghodia
Vadodara
Gujarat
India
391760
Vadodara GUJARAT 391760 India |
| Phone |
9033415831 |
| Fax |
|
| Email |
chnadnifataniya22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Homeopathic Medical College and Hospital, Parul University, Vadodara, Gujarat |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Nehru Homoeopathic Medical College and Hospital, Parul University |
| Address |
Jawaharlal Nehru Homoeopathic Medical College and Hospital
Parul University
Waghodia
Vadodara
Gujarat
India
391760 |
| 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 Chandni Pravinbhai Fataniya |
Jawaharlal Nehru Homoeopathic Medical College and Hospital |
OPD Room number 102, Department of surgery,
Jawaharlal Nehru Homoeopathic Medical College and Hospital
Parul University
Waghodia
Vadodara
Gujarat
India
391760 Vadodara GUJARAT |
09033415831
chandnifataniya22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jawaharlal Nehru Homeopathic Medical College and Hospital. Institutional Ethics Committee for Human Research |
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 |
Homeopathic Medicine |
Homoeopathic Medicines with Centesimal potency. Each dose will be directed to be taken orally on clean tongue with empty stomach. Duration of therapy 3 months with follow up at every 15 days |
| Comparator Agent |
Homoeopathic Mother Tinctures |
On basis of symptom similarity Homoeopathic mother tincture will be selected, given 10 drops of as per requirement of patient with repetition every 15 days for 3 months, doses can be tapered down during the study based on symptom similarity found in patients. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group between 18 to 60 years.
2. Patients diagnosed with Grade I to Grade III hemorrhoids, based on clinical examination.
3. Patients willing to undergo homoeopathic treatment.
4. Patients who give written informed consent to participate in the study. |
|
| ExclusionCriteria |
| Details |
1. Patients with Grade IV hemorrhoids, thrombosed hemorrhoids, severe bleeding or requiring emergency care.
2. Pregnant or lactating women.
3. Patients under ongoing allopathic or Ayurvedic treatment for hemorrhoids who are not willing to continue it during the study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Marked Improvement
Moderate Improvement
Mild Improvement
Status quo
Any increase in Hemorrhoid severity score from the baseline score will be counted as worse |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
27/01/2026 |
| 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="1" Months="0" 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
|
Hemorrhoids are a common anorectal disorder presenting with symptoms such as bleeding pain prolapse itching and discomfort. Homeopathic medicines are used in different dosage forms including centesimal potencies and mother tinctures. However there is limited clinical evidence comparing their role when medicines are prescribed based on the totality of symptoms. This study is a prospective interventional clinical study conducted to compare the role of centesimal potency and mother tincture in the treatment of hemorrhoids in adults. A total of sixty patients diagnosed with Grade I to Grade III hemorrhoids will be included and divided into two groups. In both groups medicines will be prescribed on the basis of the totality of symptoms. One group will receive the selected medicine in centesimal potency while the other group will receive the selected medicine in mother tincture form. The primary purpose of the study is to assess and compare the change in Hemorrhoid Severity Score before and after treatment in both groups. The study hypothesizes that there is a significant difference between centesimal potency and mother tincture in reducing the severity of hemorrhoidal symptoms in adults when prescribed according to symptom totality. This prospective, interventional, single arm clinical study aims to compare the role of centesimal potency and mother tincture in the homeopathic management of hemorrhoids. Sixty eligible participants will be recruited from Jawaharlal Nehru Homoeopathic Medical College and Hospital, Vadodara, Gujarat, over a study period of one year. The pain, limitations and treatment outcomes will be assessed using the Hemorrhoid severity score. |