| CTRI Number |
CTRI/2025/07/090045 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
02/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A STUDY To Evaluate Efficacy Of Marham-e-Dafe Shiqaq-al-maqad in Anal Fissure |
|
Scientific Title of Study
|
Therapeutic Evaluation Of Marham-e-Dafe-Shiqaq-al-Maqad In Case of Shiqaq-al-Maqad(Anal Fissure) |
| Trial Acronym |
Anal Fissure |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SAQUIB RAZA |
| Designation |
PG SCHOLAR |
| Affiliation |
State Takmeel ut Tib College And Hospital |
| Address |
Department Of Ilmul Jarahat State Takmeel ut Tib College
Near Ramabai Railly Sthal Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
7985393250 |
| Fax |
|
| Email |
faradayg10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Abdul Quavi |
| Designation |
Professor And HOD |
| Affiliation |
State Takmeel ut Tib College And Hospital |
| Address |
Department Of Ilmul Jarahat State Takmeel ut Tib College
Near Ramabai Railly Sthal Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
9455077880 |
| Fax |
|
| Email |
quavinium@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakhshinda Baig |
| Designation |
Reader |
| Affiliation |
State Unani Medical College Prayagraj |
| Address |
Department Of Ilmul Jarahat State Unani Medical College Prayagraj
Allahabad
UTTAR PRADESH
211001
India |
| Phone |
9415337189 |
| Fax |
|
| Email |
baigrakhshi12@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Takmeel ut Tib College And Hospital Near Ramabai Railly Sthal 226025 Lucknow UTTAR PRADESH |
|
|
Primary Sponsor
|
| Name |
State Takmeel ut Tib College And Hospital |
| Address |
Department of Ilmul Jarahat Near Ramabai Railly Sthal 226025 Lucknow UTTAR PRADESH |
| Type of Sponsor |
Government 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 SAQUIB RAZA |
State Takmeel ut Tib College And Hospital Lucknow |
Department of Ilmul Jarahat Near Ramabai Railly Sthal
Bijnor Road 226025 Lucknow UTTAR PRADESH
Lucknow
UTTAR PRADESH |
7985393250
faradayg10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee State Takmeel ut Tib College And Hospital Lucknow |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K928||Other specified diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Marham e Dafe Shiqaq al Maqad include following ingredient:Mom safed 12gm,Barg-e-hina 9gm,Rogan gul 40 ml And Safoof Mulaiyyan include following ingredients: Sana makki,Post halela zard,Zanjabeel,Namak syah |
Marham e Dafe Shiqaq al Maqad
Route of administration:local application for 6 weeks BD
Safoof mulaiyyan:5gm HS |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of Shiqaq-al-Maqad (Anal Fissure) (anterior &
posterior)
Patients irrespective of sex religion occupation & economical status
Patients of both the sexes in between the age group of 18 to 60 years |
|
| ExclusionCriteria |
| Details |
Anal Fistula
External sphincter deffect
Haemorrhoids
Rectal Prolapse
Anal/perianal abscess
Anal Fissure secondary to Ulcerative colitis Syphilis, Crohn’s disease
Tuberculosis and malignancy of rectum and anal canal
Pregnancy
Advanced Anal Fissure
Venereal diseases
Severe anaemia
Mentally Retarded Patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in
Pain during & after defection
Constipation
Per rectal bleeding
|
Clinical assessment will be done at 0,14th, 28th & 42nd days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Diagnosed by simple rectal examination
Visual Analogue Scale (VAS) |
Clinical assessment will be done at 0,14th, 28th & 42nd days. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
21/07/2025 |
| 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="1"
Months="6"
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
|
Title: Therapeutic Evaluation of Marham-e-Dafe Shiqaq-al-Maqad in Case of Shiqaq-al-Maqad (Anal Fissure)
Researcher: Dr Saquib Raza PG Scholar Department of Ilmul Jarahat State Takmeel-ut-Tib College and Hospital Lucknow
Overview: This clinical research aims to evaluate the effectiveness of a traditional Unani formulation—Marham-e-Dafe Shiqaq-al-Maqad—for treating anal fissures a common and painful anorectal condition
Objectives:
Prevent surgical intervention and associated complications
Assess the healing efficacy of the Unani ointment and laxative combination.
Halt progression of acute fissures into chronic ones.
Methodology:
Design: Open-label single-arm interventional clinical study
Sample Size: 30 patients (18–60 years)
Duration: 6 weeks
Treatment:
Topical: Marham-e-Dafe Shiqaq-al-Maqad (BD)
Oral: Safoof Mulaiyyan (5g at bedtime)
Assessment Tools: Clinical exam Visual Analogue Scale (VAS) for pain rectal examination
Inclusion/Exclusion: Patients with simple anal fissures included other anorectal or systemic conditions excluded
Outcomes: Measured through symptom relief (pain bleeding constipation healing of fissure and safety parameters (blood tests)
Significance: The study explores a cost-effective side-effect-free alternative from Unani medicine for managing anal fissures especially chronic ones resistant to conservative modern treatments. |