| CTRI Number |
CTRI/2025/03/082632 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of topical Unani formulation in the pateints of Tinea Corporis: An open-label, randomised controlled trial |
|
Scientific Title of Study
|
Therapeutic efficacy of a topical unani formulation containing Sirka and Samgh-i-Arabi in the management of Quba Khabith (Tinea Corporis): An open labeled, randomised clinical trial with standard control |
| 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 Asgar Nazir |
| Designation |
Lecturer Department of Moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
| Address |
Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir
Srinagar JAMMU & KASHMIR 190006 India |
| Phone |
6005516889 |
| Fax |
|
| Email |
drasgarnazir11@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Asgar Nazir |
| Designation |
Lecturer Department of Moalajat |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
| Address |
Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir
Srinagar JAMMU & KASHMIR 190006 India |
| Phone |
6005516889 |
| Fax |
|
| Email |
drasgarnazir11@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Adnan Ali |
| Designation |
PG Scholar |
| Affiliation |
Regional Research Institute of Unani Medicine (RRIUM), Srinagar |
| Address |
Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir
Srinagar JAMMU & KASHMIR 190006 India |
| Phone |
9212999960 |
| Fax |
|
| Email |
dr.adnan.ali999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine (CCRUM), New Delhi 110058, India. |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine CCRUM New Delhi India |
| Address |
Regional Research Institute of Unani Medicine (RRIUM), University of Kashmir, Srinagar 190006, 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 Asgar Nazir |
Regional Research institute of unani medicine(RRIUM) Srinagar |
Moalajat OPD-1,
Ground Floor,
Department of Moalajat,
RRIUM, Naseem bagh
Campus, University of
Kashmir Hazratbal
Srinagar
JAMMU & KASHMIR Srinagar JAMMU & KASHMIR |
6005516889
drasgarnazir11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, RRIUM Srinagar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Semi-solid unani formulation |
Compound Test drug formulation in semi-solid form with two main ingredients, Sirka, and Samgh-i-Arabi, for topical application. Both ingredients, Sirka and Samgh-i-Arabi, will be mixed in equal quantities to form the solution. In patients in the the test group, compound test drug formulation will be applied locally twice a day for 28 days. Topical antifungal medication will be used to the lesion at least 2 cm beyond the margin. |
| Comparator Agent |
Terbinafine cream 1% for local application |
Topical antifungal medication is to be applied twice a day locally for 28 days.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with Quba Khabith (tinea corporis)
2. Patients in the age group of 18 to 60 irrespective of gender
3. KOH (potassium hydroxide) positive
4. Patients willing to sign written informed consent
|
|
| ExclusionCriteria |
| Details |
1. Patients below the age of 18 years and above 60 years
2. History of drug-induced allergy
3. Pregnant or breastfeeding mothers
4. Active case of malignancy
5. Patients having diabetes mellitus or cardiovascular or renal diseases.
6. Unwillingness or inability to fulfill the protocol or patients who fail to consent.
7. KOH (potassium hydroxide) negative
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Typical Lesion with itching, Scaling, Erythema, Papules, Vesicles
2. KOH (potassium hydroxide) Negative
3. TSSS (Total sign and symptoms score) |
7th, 14th, 21st, and 28th day of the study. KOH will be assessed on 0th and 29th (before and after) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. DLQI (Dermatology life quality index)
2. Pre and Post photograph of the lesion site |
0th and 29th (Before and After) |
|
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
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)
|
10/04/2025 |
| 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="0" 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
|
Tinea corporis is variously named ringworm, dermatophytosis, favus, or daad. It is a clinical condition caused by a fungal infection of the skin, hair, and nails. The fungus is keratophyllic affecting the outer layer of the skin to produce ring-shaped lesions with a papulo-vesicular margin and central clear area. According to WHO estimates, tinea corporis infects between 20 to 25% of the world population. It occurs most frequently in post-pubertal children and young adults with no sex differentiation. Climate conditions all around the world have influenced the incidence variability. Many effective synthetic antifungal drugs have been discovered for the treatment of tinea corporis, but their use has remained limited due to various side effects. Unani herbal medicine, whether a single herb, compound formulations, or regimental therapy, has also been used for this purpose since ancient times. However, only a few of them have been evaluated on scientific grounds for their efficacy. The need of the hour is to validate the herbal preparations mentioned in our classical texts, which are otherwise safe, fairly available, and easily affordable by the general public, on scientific parameters. In this context, we selected a trial to evaluate the therapeutic efficacy of a topical unani formulation containing Sirka and Samgh -i-Arabi in the management of Quba Khabith (Tinea corporis), which is a randomized study with standard control. |