| CTRI Number |
CTRI/2026/01/100496 [Registered on: 07/01/2026] Trial Registered Prospectively |
| Last Modified On: |
05/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment of Anal Fissure Unani Medicine or Surgery |
|
Scientific Title of Study
|
Comparative evaluation of Unani Formulation and Lateral Internal Sphincterotomy in the Treatment of Shiqaq-al-maqad (Anal fissure)-A Randomized Controlled Clinical 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 Afa Khatoon Naseem Ahmed Khan |
| Designation |
PG Scholar |
| Affiliation |
National Institue of Unani Medicine Banagalore |
| Address |
Department Of Ilmul Jarahat Institute Of Unani Medicine Kottigapalya Magadi Main Road Banagalore
NIUM New girls hostel
Magadi Road Kottigapalya
Banagalore, karnataka
Bangalore
KARNATAKA
560091
India |
| Phone |
08433630508 |
| Fax |
|
| Email |
drafakhan123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mehjabeen Fatimah |
| Designation |
Associate Professor Department of Ilmul Jarahat |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department of Ilmul jarahat National Institute of Unani medicine Kottigapalya Magadi Main Road Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
8057438462 |
| Fax |
|
| Email |
fatimahmehjabeen@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mehjabeen Fatimah |
| Designation |
Associate Professor Department of Ilmul jarahat |
| Affiliation |
National Institute of Unani Medicine |
| Address |
Department Of Ilmul jarahat
National Institute of Unani Medicine Kottigapalya Magadi Main Road Bangalore
Bangalore
KARNATAKA
560091
India |
| Phone |
8057438462 |
| Fax |
|
| Email |
fatimahmehjabeen@gamil.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine Kottigapalya Magadi Main Road Bangalore 560091 |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
Department Of Ilmul jarahat
National Institute of Unani Medicine Kottigapalya Magadi Main Road Bangalore
Department of Ilmul jarahat
National Institute of Unani Medicine Kottigapalya Magadi Main Road Bangalore 560091
Karnataka Inidia |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrAfa khatoon Naseem Ahmed khan |
National Institute of Unani Medicine |
OPD 07 Department of Surgery
Bangalore
KARNATAKA |
8433630508
drafakhan123@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Institutional Ethics Committee for Biomedical Research |
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 |
| Comparator Agent |
Lateral Internal Sphincterotomy |
Patients will be managed surgically. They will be assessed on 0th day, 7th day, 14th day,21st day and after 1 month post treatment. |
| Intervention |
Unani Formulation |
The ingredients of the Unani formulation will be procured from the authentic and reliable sources. After Procurement, the raw drugs will undergo drug identification test before preparation. After that Unani formulation will be prepared by melting Mom safed in Rogan-e-gul over gentle heat.Upon complete dissolution, finely powdered Henna will be incorporated gradually with continuous stirring to ensure homogenous mixing. After achieving a uniform consistency, the mixture will be allowed to cool at room temperature. The final product will be dispensed to patients in the form of an ointment, packed in pre- sterilized containers under aseptic conditions. Then the patients will be provided with the Unani formulation for local application twice daily for 21 days. Assessment will be done on baseline, 7th day, 14th day and 21st day and after 1 month post treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients diagnosed with Anal fissure
patients willing to provide written informed consent and comply with the requirements of this study protocol |
|
| ExclusionCriteria |
| Details |
Fissures associated with third and fourth-degree or thrombosed piles
Known case of malignancy
Multiple fissures
Pregnant and lactating mothers
Patients with Systemic disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Healing of fissure
Tenderness on digital examination
Anal sphincter spasm |
0 day
7th day
14th day
21st day
1 month post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
REALISE SCORE
(Pain vas score 0-10, duration of pain, intake of analgesics, bleeding and quality of life) |
0th, 7th ,14th,21st and after 1 month post treatment. |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/01/2026 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A fissure in Ano is a linear tear in the anal canal that extends from the dentate line proximally to the anal margin distally. It is usually found in the posterior or anterior midline. Anal fissure produces significant discomfort and bleeding with bowel movements and are accompanied with spasms of the internal anal sphincter, which can result in reduced blood flow and delated healing. Anal fissure treatment involves suppression of pain, spasm and Ischemia. A different treatment approach is surgery.purpose of trial is to manage the anal fissure by application of the Unani formulation with its primary objective of finding an accessible non operative, painless, safe, affordable and efficient remedy and this classical medicine will be compared with Lateral internal sphincterotomy. |