| CTRI Number |
CTRI/2025/07/090004 [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
|
To Evaluate the Therapeutic Effect of Marham E Raal in cases of non healing ulcer : A clinical study |
|
Scientific Title of Study
|
THERAPEUTIC EVALUATION OF MARHAM-E-RAAL IN THE MANAGEMENT OF QARHA ASIR AL INDIMAL (NON-HEALING ULCER) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR AREEBA NAAZ |
| Designation |
PG SCHOLAR |
| Affiliation |
State Takmeel Ut Tib College And Hospital |
| Address |
Department Of Ilmul Jarahat State Takmeel Ut Tib College And Hospital Near Ramabai Ambedkar Raili Sthal Rd Babasaheb Bhim Rao Ambedkar University Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
8439390462 |
| Fax |
|
| Email |
areebanaazdmp1234@gmail.com |
|
Details of Contact Person
Scientific 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 |
09415337189 |
| Fax |
|
| Email |
baigrakhshi12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Abdul quavi |
| Designation |
Prof And HOD |
| Affiliation |
State Takmeel Ut Tib College And Hospital |
| Address |
Department Of Ilmul Jarahat State Takmeel Ut Tib College And Hospital Near Ramabai Ambedkar Raili Sthal Rd Babasaheb Bhim Rao Ambedkar University Lucknow
Lucknow
UTTAR PRADESH
226025
India |
| Phone |
9455077880 |
| Fax |
|
| Email |
quavinium@gmail.com |
|
|
Source of Monetary or Material Support
|
| State Takmeel Ut Tib College And Hospital Near Ramabai Ambedkar Raili Sthal Rd Babasaheb Bhim Rao Ambedkar University Lucknow Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
State Takmeel ut Tib College And Hospital |
| Address |
Near Ramabai Ambedkar Raili Sthal Rd Babasaheb Bhim Rao Ambedkar University 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 AREEBA NAAZ |
State Takmeel ut Tib College And Hospital |
Department of Ilmul Jarahat Near Ramabai Ambedkar Raili Sthal Rd Babasaheb Bhim Rao Ambedkar University 226025 Lucknow Uttar Pradesh
Lucknow
UTTAR PRADESH |
8439390462
areebanaazdmp1234@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: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Marham e raal including following ingredient
Mom-12gm
Raal-12gm
Kafoor-12gm
Kaat safed-12gm
Roghan Gao |
Local application Twice a day for 45 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Both genders
Ulcers not healing for more than 6 weeks
Wagners grading 0 1 and 2 ulcers
Patient in age group 18-70 years
Controlled diabetes mellitus |
|
| ExclusionCriteria |
| Details |
Gangrenous and Malignant ulcer
Mentally retarded
Uncontrolled diabetes mellitus
Patient with any severe systemic disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Imrovement in Discharge
Pain (VAS scoring)
No. of wound |
clinical assessement will be done at 0 15th 30th 45th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Wagner’s grading of ulcer
Area of wound in square centimetres
Appearance of healthy granulation tissues
Epithelisation in percentage
Depth of wound in centimetres
No of days for healing |
0 15th 30th 45th day |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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
|
The dissertation aims to evaluate the efficacy of Marham-e-Raal in the management of non-healing ulcers (Qarha Asir Al-Indimal) The study is designed to find a convenient affordable and cost-effective remedy to prevent or save patients from amputation given the high prevalence of non-healing ulcers and the risk of amputation The document includes an introduction to Qarha Asir Al-Indimal discussing its impact prevalence and factors affecting healing It also provides a literature review on Jarahat (wound) and Qurooh (ulcer) according to the Unani system of medicine classifying ulcers into simple compound and non-healing categories |