| CTRI Number |
CTRI/2024/09/073670 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effects of Marham Abyaz in the treatment of Shiqaq-ul-Maqad (Anal Fissure) |
|
Scientific Title of Study
|
Therapeutic Evaluation of Marham Abyaz in patients of Shiqaq ul Maqad (Anal Fissure) : An Interventional 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 |
Dr Asma Mohammad Tahir |
| Designation |
PG Scholar |
| Affiliation |
State Takmeel-ut-Tib College and Hospital |
| Address |
Ground floor,Room no 112,jarahat OPD, Department of Ilmul Jarahat, State Takmeel-ut-Tib College and Hospital, near Ramabai Rally Sthal, Bijnor Road, Lucknow
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
8506037571 |
| Fax |
|
| Email |
asmamdtahir786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Abdul Quavi |
| Designation |
Head of Department |
| Affiliation |
State Takmeel-ut-Tib College and Hospital |
| Address |
Department of Ilmul Jarahat,State Takmeel-ut-Tib College and Hospital, near Ramabai Rally Sthal, Bijnor Road, Lucknow
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
9826212048 |
| Fax |
|
| Email |
quavinium@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakhshinda Baig |
| Designation |
Reader |
| Affiliation |
State Takmeel-ut-Tib College and Hospital |
| Address |
Department of Ilmul Jarahat,State Takmeel-ut-Tib College and Hospital, near Ramabai Rally Sthal, Bijnor Road, Lucknow
Lucknow
UTTAR PRADESH
226012
India |
| Phone |
9415337189 |
| Fax |
|
| Email |
baigrakhshi12@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Takmeel-ut-Tib College and Hospital |
|
|
Primary Sponsor
|
| Name |
State Takmeel ut Tib College and Hospital |
| Address |
Near Ramabai Rally Sthal Bijnor Road Lucknow,Uttar Pradesh India 226012 |
| 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 Asma Mohammad Tahir |
State Takmeel-ut-Tib College and Hospital |
Jarahat OPD Ground Floor Room no 112 Department of Ilmul Jarahat
Lucknow
UTTAR PRADESH |
8506037571
asmamdtahir786@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 |
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 |
Marham abyaz |
Marham Abyaz local application twice daily for 6 weeks |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of Shiqaq-al-Maq’ad (Anal Fissure) (anterior & posterior)
Patients irrespective of sex, religion, occupation & economical status. |
|
| ExclusionCriteria |
| Details |
Anal Fistula
Haemorrhoids
Anal/perianal abscess
Fissure-in-ano secondary to Ulcerative colitis, Syphilis, Crohn’s disease, Tuberculosis and malignancy of rectum and anal canal
Pregnancy
Venereal diseases
Severe anaemia
Diabetes Mellitus
Mentally Retarded Patients |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To eradicate pain during and after defecation
To prevent constipation
To stop per rectal bleeding
To stop per rectal itching |
0, 7th , 14th, 21st, 28th, 35th, 42nd days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To treat the Anal Fissure |
42 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
20/09/2024 |
| 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="10" |
|
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
|
The prevalence of anal fissure among patients with anorectal complaints is around 30.7%. Although Anal Fissure is not fatal, but can significantly influence the quality of life due to its troubling symptoms such as severe pain, bleeding per rectum, spasm of the internal sphincter .Anal dilatation and lateral sphincterotomy are the treatment of choice in modern system of medicine. These procedures have their own limitations and complications, such as recurrence and incontinence of stools in the post operative patients are common. So the aim and objective of this study is To treat Shiqaq-ul-Maqad (Anal Fissure) with Unani Compound Drug. To evaluate the efficacy of Marham Abyaz in patients of Shiqaq-ul-Maq’ad. To gather detailed knowledge on Shiqaq-ul-Maq’ad (Anal Fissure). Ongoing clinical research are important to refine diagnostic modalities and therapeutic strategies. |