| CTRI Number |
CTRI/2025/03/081897 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Diagnostic |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treatment Of Non Healing Ulcer With Unani Drug (Aelwa,Murmakki,Anzaroot,Kundur) |
|
Scientific Title of Study
|
A Comparative Clinical Study Of Unani Formulation (Aelwa,Murmakki,Anzaroot,Kundur) and povidone Iodine Betadine 5 Percent In The Management Of Non Healing Ulcer A Randomised Control 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 Ramlah Hussain |
| Designation |
PG Scholar |
| Affiliation |
Ilmul Jarahat |
| Address |
Department Of Ilmul Jarahat National Institute Of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
9771764292 |
| Fax |
|
| Email |
ramlahjauhar@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Saiyad Shah Alam |
| Designation |
HOD Ilmul Jarahat |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department Of Ilmul Jarahat, OPD Block, Room No 07, National Institute Of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
8792683039 |
| Fax |
|
| Email |
shahalam1971@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Saiyad Shah Alam |
| Designation |
HOD Ilmul Jarahat |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department Of Ilmul Jarahat, OPD Block, Room NO 07, National Institute Of Unani Medicine, Kottigepalya, Magadi Main Road, Bengaluru
Bangalore
KARNATAKA
560091
India |
| Phone |
8792683039 |
| Fax |
|
| Email |
shahalam1971@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Unani Medicine, KOttigepalya Magadi Main Road Banglore 560091 Karnataka India |
|
|
Primary Sponsor
|
| Name |
National Institute Of Medicine |
| Address |
National Institute Of Unani Medicine, Kottigepalya, Magadi Main Road, 560091 Bengaluru,Karnataka,India |
| 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 |
| Dr Ramlah Hussain |
National Institue Of Unani Medicine |
Department Of Ilmul Jarahat,OPD Block,Room No 07,National Institute Of Unani Medicine, Kottigepalya,Magadi Main Road,Bengaluru 560091, Karnataka
Bangalore
KARNATAKA |
9771764292
ramlahjauhar@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication Of Decision Of The Institutional Ethics Committee (IEC) For Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Povidone Iodine 5% Ointment |
The Patient Of The Control Group With Povidone Iodine 5% (Betadine). The Dressing Will Be Changed On Alternate Days.The Wound Will Be Assessed On Every 0th 15th 30th And 45th Day During Treatment Wound Will Be Measured By Graph Paper In Square Centimeters Or Millimetres Appearance Of Granulation Tissue Photography Of Affected Part (With Written Consent Of Patients) Covering Of epithelial Tissue Depth Of Wound By Wagners Grading Scale The Colour Of Surrounding Skin And Pain. |
| Intervention |
Zaroor Of Aelwa Murmakki Anzaroot Kundur |
All Dried Crude Drugs (Aelwa MurMakki Anzaroot Kundur) Will Be Cleaned Crushed And Grinded With The Help Of An Electric Grinder To Get The Fine Powder And Each Drug Will Be Mixed In Equal Quantities In NIUM Pharmacy According To Kitab Al-Qarabadeen For Dressing The Wound First Cleaning Will Be Done With Normal Saline Under All Aseptic Conditions Dried With A Gauze Piece And Powder Of Research Drug Will Be Sprinkled On The Wound Then It Will Be Covered With A Dry Gauze Piece And Wrapped With A Cot ton Bandage On Alternate Days The Wound Will Be Assessed On Every 0th 15th 30th and 45th Day During Treatment Wound Will Be Measured By Graph Paper In Square Centimeters Or Millimetres Appearance Of Granulation Tissue Photography Of Affected Part (With Written Consent Of Patients) Covering Of epithelial Tissue Depth Of Wound By Wagners Grading Scale The Colour Of Surrounding Skin And Pain.ton Bandage On Alternate Days. The Duration Of The Study Will Be 45 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
All genders
Ulcers Not Healing For More Than 6 weeks.
Wagners Grading 0 1 and 2 Ulcers.
Patient Age group 18 70 years.
|
|
| ExclusionCriteria |
| Details |
Gangrenous andMalignantulcers.
Pregnantand Lactatingwomen.
Patientwith anyseveresystemic disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Discharge
Pain (Yes/No)
No.of wound
|
alternate day dressing starting from 0th Day,15th Day,30th Day,45th Day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
VAS Scoring Of Pain
Wagners Grading Of Ulcer
Area Of Wound In Square Centimetres.
Appearance Of Healthy Granulation Tissue
Epithelisation In Percentage
Depth Of Wound In Centimetres
No. Of Days For Healing
|
0th 15th 30th 45th |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/03/2025 |
| 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
|
| An ulcer is a break in the continuity of the covering epithelium either skin or mucous membrane due to molecular death of the surface epithelium or its traumatic removal.1Non-healingulcers are those that do not heal after 6 weeks of conservativetherapy.2 Chronic non-healing ulcers are a major health issue that affects an estimated 2-6 million people in the United States alone, with global prevalence ranging from 1.9 to 13.1%.3 Leg ulcers affect approximately 1-2% of the population. Chronic venous insufficiency contributes to approximately 60% of all chronic leg ulcers.4 The prevalence of non-healing venous ulcers ranges between 1 and 2%, accounting for nearly 75-80% of all vascular ulcers.3 Arterial ulcers are the most common ulcer in the age group of 41 to 50 years. Atherosclerosis is the commoner association with arterial ulcer constituting 58.4% and other association with arterial ulcer thromboangitis obliterans accounting for 44.6%.5 Globally 463 million people are living with diabetes; The life time risk of a person with diabetes having foot ulcer has been reported to be as high as 25%. In India the numbers of diabetic foot patients are increasing in both urban and rural areas with 85% of amputation preceded by foot ulcer. In India approximately 100,000 legs are amputated every year.6 The management of non-healing ulcers comprises, the treatment of the underlying cause, wound cleansing and dressing, personal hygiene, infection management, and wound closure.3 Many chronic ulcers refuse to heal or linger for months/years despite therapy, and/or relapse after healing, necessitating the use of advanced wound care therapies such as Hyperbaric Oxygen therapy, skingrafting, Gene therapy, Stem cell therapy, Shock wave, VAC (Vacuum aided closure), and surgical management as angioplasty and reconstructive surgery etc3 are available and costly treatments for non-healing ulcers. OBJECTIVE OF STUDY: To Assess the efficacy of the Unani formulation (Aelwa, MurMakki, Anzaroot, Kundur) in comparison to Povidone iodine 5%ointment. | |