| CTRI Number |
CTRI/2025/08/093639 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study to Compare Homoeopathic Medicines with Hamamelis Virginica Ointment in the Treatment of Anal Fissures |
|
Scientific Title of Study
|
Comparative Study of Individualized Homoeopathic Medicines and Hamamelis Virginica Ointment in the Management of Anal Fissures - A Randomized Control 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 Mohammed Nizamuddin Kalimoddin Shaikh |
| Designation |
Doctor and PhD Scholar |
| Affiliation |
Dr. D. Y. Patil Homoeopathic Medical College and Research Centre |
| Address |
Dr. D. Y. Patil Homoeopathic Medical College and Research Centre
Sant Tukaram Nagar, Pimpri, Pune-411018, (Maharashtra) India
Pune
MAHARASHTRA
411018
India |
| Phone |
8485862159 |
| Fax |
|
| Email |
drnizamuddinshaikh84@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parth Aphale |
| Designation |
PhD Guide |
| Affiliation |
Dr. D. Y. Patil Homoeopathic Medical College and Research Centre |
| Address |
Dr. D. Y. Patil Homoeopathic Medical College and Research Centre
Sant Tukaram Nagar, Pimpri, Pune-411018, (Maharashtra) India
Pune
MAHARASHTRA
411018
India |
| Phone |
9422521722 |
| Fax |
|
| Email |
parth.aphale@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parth Aphale |
| Designation |
PhD Guide |
| Affiliation |
Dr. D. Y. Patil Homoeopathic Medical College and Research Centre |
| Address |
Dr. D. Y. Patil Homoeopathic Medical College and Research Centre
Sant Tukaram Nagar, Pimpri, Pune-411018, (Maharashtra) India
Pune
MAHARASHTRA
411018
India |
| Phone |
9422521722 |
| Fax |
|
| Email |
parth.aphale@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Mohammed Nizamuddin Kalimoddin Shaikh |
| Address |
Dr. D. Y. Patil Homoeopathic Medical College and Research Centre
Sant Tukaram Nagar, Pimpri, Pune-411018, (Maharashtra) India |
| 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 Mohammed Nizamuddin Kalimoddin Shaikh |
Dr. D. Y. Patil Homoeopathic Medical College and Research Centre |
Sant Tukaram Nagar, Pimpri, Pune, Maharashtra, India
Pune
MAHARASHTRA |
8485862159
drnizamuddinshaikh84@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr. D.Y Patil VIdyapeeth Ethics Committee |
Approved |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K602||Anal fissure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A - Individualized Homoeopathic Medicines and Hamamelis virginica Ointment |
Fifty patients will receive individualized homoeopathic medicines prescribed orally on the basis of totality of symptoms, along with topical application of Hamamelis virginica ointment prepared and manufactured by Bakson Drugs and Pharmaceuticals Pvt. Ltd. The ointment will be applied externally on the site of anal fissure twice daily, for a total duration of 6 weeks. |
| Comparator Agent |
Group B - Hamamelis virginica Ointment |
Fifty patients will receive topical application of Hamamelis virginica ointment prepared and manufactured by Bakson Drugs and Pharmaceuticals Pvt. Ltd. externally on the anal region or site of anal fissure twice daily, for a total duration of 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged between 18-60 years with a confirmed diagnosis of anal fissures will be included.
Patients of both Genders, irrespective of their socio economical state are to be considered. |
|
| ExclusionCriteria |
| Details |
Patients of age below 18 years and above 60 Years.
Patients who don’t want to give Consent.
Patients with other gastrointestinal disorders, those who have undergone previous surgeries for anal conditions, or individuals currently taking medications that could interfere with study results will be excluded.
Individuals with other Anal Conditions such as Hemorrhoids, Proctitis, Anal Abscesses, Anal Fistulas, Rectal Prolapse, Rectal Cancer, Anal Cancer, Anal Warts, Pregnancy, Coagulopathies or Patients taking Anticoagulant Therapies. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Individualized Homoeopathic Medicines along with Hamamelis Virginica Ointment are more effective than Hamamelis Virginica Ointment alone, in the management of anal fissures. |
6 Weeks after treatment initiation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/09/2025 |
| 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="3"
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
|
This study will compare two treatments for anal fissures in 100 patients. One group will receive individualized homoeopathic medicines along with Hamamelis virginica ointment, and the other group will receive Hamamelis virginica ointment alone. After 6 weeks, the outcome of each case will be measured. |