| CTRI Number |
CTRI/2025/07/090353 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Treatment of Ringworm Skin Infection using a Traditional Unani Topical Remedy in patients |
|
Scientific Title of Study
|
Efficacy of topical Samagh-e-Arabi (Acacia Arabica Willd) with Sirka
(Vinegar) in Quba Mutaqashshir (Tinea Corporis)A Non-Randomized Clinical Trial
|
| 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 Patel Hafsa Nooruddin |
| Designation |
PG SCHOLAR |
| Affiliation |
Government Unani Medical College |
| Address |
Government Unani Medical College,
Department of PG–Moalajat, Rooom No.5M,
Arignar Anna Hospital Campus,
Arumbakkam,
Chennai.
Chennai TAMIL NADU 600106 India |
| Phone |
7030310859 |
| Fax |
|
| Email |
hafsapatel2913@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Mushtaq Ahmed MD |
| Designation |
Professor |
| Affiliation |
Government Unani Medical College, Chennai |
| Address |
OP No. 5M
Department of PG Moalajat
Government Unani Medical College
Arignar Anna Hospital Campus
Arumbakkam, Chennai
Chennai TAMIL NADU 600106 India |
| Phone |
9884156051 |
| Fax |
|
| Email |
drcmushtaq65@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Mushtaq Ahmed MD |
| Designation |
Professor |
| Affiliation |
Government Unani Medical College |
| Address |
OP No.5M
Department of PG Moalajat
Government Unani Medical College
Arignar Anna Hospital Campus
Arumbakkam, Chennai
Chennai TAMIL NADU 600106 India |
| Phone |
9884156051 |
| Fax |
|
| Email |
drcmushtaq65@gmail.com |
|
|
Source of Monetary or Material Support
|
| AAGHIM, Anna Hospital Campus, Arumbakkam, Chennai 600106 |
|
|
Primary Sponsor
|
| Name |
Government Of Tamilnadu |
| Address |
Government Unani Medical College Arumbakkam,Chennai-600106 |
| 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 Patel Hafsa Nooruddin |
Arignar Anna Government Hospital of Indian Medicine |
Department of Moalajat
Unani Division, Room No. 5M
Arumbakkam,
Chennai – 600106
Tamil Nadu, India Chennai TAMIL NADU |
7030310859
hafsapatel2913@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of Decision of the Instituitional Ethics Committee(IEC) for Unani Medical Research for PG Scholars of M.D.(Unani) affiliated to The TN Dr. MGR Medical University, Chennai |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Topical Samagh-e-Arabi (Acacia Arabica Willd) with Sirka
(Vinegar) |
Samagh-e-Arabi (Acacia arabica Willd) will be powdered and soaked in required amount of sirka (vinegar) for topical application on the lesion, ROUTE OF ADMINISTRATION-Topical, DOSAGE-As much as required, twice a day,(after 10-15 minutes wiped with sterile gauze).
Duration of Treatment-28days,
FOLLOW-UP: 7, 14, 21, 28th day
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Circumscribed lesions on trunk and limbs with itching, erythema, scales, central clearing with peripheral raised margins.
Participants diagnosed with Positive Mycology (KOH positive).
|
|
| ExclusionCriteria |
| Details |
Patients below the Age of 18 Years and above the age of 60 Years.
Participants suffering from severe systemic or metabolic diseases.
Participants suffering from concomitant conditions, or diseases like Psoriasis, Eczema
Pregnant Or Lactating Women.
Known Cases of Immuno-Compromised States (HIV/ AIDS, Etc.)/ Malignancies.
Participants not willing to follow the protocol
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in Total Sign and Symptom Score (TSSS).
KOH Examination:
Complete Elimination of fungal elements in KOH examination at the 28th day of treatment in comparison to baseline
|
Total Sign and Symptom Score (TSSS):7th day,14th day,21st day,28th day
KOH examination: Baseline,28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
18/07/2025 |
| 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
|
Tinea corporis, known as Quba in Unani medicine, refers to superficial fungal infections affecting the skin, excluding the scalp, beard, face, hands, feet and groin. It presents as circular erythematous scaly and hypopigmented patches with central clearing, forming characteristic ring like lesions called Ringworm. Dermatophytes infect the keratinized stratum corneum but cannot penetrate deeper tissues. In Unani medicine, Quba also called Karyun or Dad, is caused by mirrha-e-sawda or abnormal black bile and involves the body natural forces. Quwwat-i-Tabaiyya diverts harmful humor or Khilt-i-Bad to the skin. Symptoms include roughness, itching, scaling, and dry lesions that may appear blackish, reddish, or pus-filled depending on the causative agents. Globally, tinea infections affect twenty to twenty five percent of the population with high prevalence in India. Males are more susceptible due to outdoor exposure, heat, and friction. According to the Unani system of medicine, the treatment of Quba focuses on the causative factors, such as Akhlat, and the disease intensity, duration, and clinical signs. Numerous Traditional healers have also suggested medications with Mudammil-e-Quruh (healing) and Musaffi-i-dam (blood purifier). Unani physicians have placed a strong focus on topical treatment using products like Zimad (paste), Tila (liniment), and Marham (ointment). Conventional medicine relies on antifungals and corticosteroids, but increasing resistance and recurrence highlight the need for safer alternatives. This study evaluates Samagh-e-Arabi (Acacia Arabica) with Sirka (vinegar), a Unani formulation from Kitabul Umda fil Jarahat, as a potential remedy for Quba. The aim is to provide an effective traditional therapeutic option amid rising antifungal resistance and economic burdens in dermatophytosis management. |