| CTRI Number |
CTRI/2025/10/096590 [Registered on: 29/10/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| 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
|
A Clinical Study on Tinea Corporis And Tinea Cruris |
|
Scientific Title of Study
|
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study To Evaluate The Safety And Efficacy Of A Unani Formulation (Topical) Compared With Terbinafine (Topical) In The Management Of Quba (Tinea Corporis And Tinea Cruris) |
| 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 Farhana Farheen Aqueel Ahmed |
| Designation |
PG Scholar |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders, Hyderabad |
| Address |
Department Of Moalajat (Medicine),National Research Institute Of Unani Medicine For Skin Disorders,Opposite ESI Hospital, AG Colony Road, Erragadda, Hyderabad-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
8484947629 |
| Fax |
|
| Email |
farhanaaqueel851@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arzeena Jabeen |
| Designation |
Principal & Professor |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders, Hyderabad |
| Address |
Department Of Moalajat (Medicine),National Research Institute Of Unani Medicine For Skin Disorders,Opposite ESI Hospital,AG Colony Road,Erragadda,Hyderabad-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
9032519286 |
| Fax |
|
| Email |
aarzu763@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Farhana Farheen Aqueel Ahmed |
| Designation |
PG Scholar |
| Affiliation |
National Research Institute of Unani Medicine for Skin Disorders, Hyderabad |
| Address |
Department Of Moalajat (Medicine),National Research Institute Of Unani Medicine For Skin Disorders,Opposite ESI Hospital,AG Colony Road, Erragadda, Hyderabad-500038
Hyderabad
TELANGANA
500038
India |
| Phone |
8484947629 |
| Fax |
|
| Email |
farhanaaqueel851@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Research Institute of Unani Medicine for Skin Disorders,Hyderabad |
|
|
Primary Sponsor
|
| Name |
National Research Institute of Unani Medicine for Skin Disorders (NRIUMSD) |
| Address |
Opposite ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana-500038 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CCRUM |
New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Farhana Farheen Aqueel Ahmed |
National Research Institute of Unani Medicine for Skin Disorders,Hyderabad |
OPD and IPD Of Department Of Moalajat,NRIUMSD,Opposite ESI Hospital,AG Colony Road, Erragadda,Hyderabad 500038
Hyderabad
TELANGANA |
8484947629
farhanaaqueel851@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee, NRIUMSD, Hyderabad,Telangana 500038 |
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 |
Terbinafine 1% cream |
Dosage Form: 1% cream,
Route Of Administration: Topical Application,
Instructions: Cream will be applied topically on the affected site twice daily for 6 weeks,
Quantity: Sufficient as per requirement. |
| Intervention |
Topical Unani Formulation |
Form: Habb(Pill) to be used in the form of Tila(liniment), Route of Administration: Topical Application, Quantity: Quantity sufficient based on the extent of lesions, Instructions: Participants will be advised to crush the pill (Habb)
in water to make Tila(liniment) and apply topically on the affected site twice daily for 6 weeks. Ingredients: Suhaga(Tinkar), Gandhak Zard, Muqil(Guggul), Loban(Benzoin), Kath Safaid, Leemu Kaghzi. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants of any gender in age group of 18-60 years
2. Participants of Quba (Tinea Corporis and Tinea Cruris) having circumscribed lesions with any of the following signs and symptoms on body, limbs and groin:
a. Presence of pruritus and burning
b. Presence of scales
c. Presence of central clearing
d. Erythematous papules
3. Participants with Positive KOH (10%) Smear Microscopy of Skin Scrapping from the active lesion for Dermatophytic Hyphae |
|
| ExclusionCriteria |
| Details |
1. Age below 18 years and above 60 years
2. Patients with other form of tinea infection like tinea capitis (head), tinea pedis (foot), tinea mannum (hands), tinea unguium (nails), tinea barbae (beard), tinea faciei (face), etc.
3. Patients with other concomitant diseases like psoriasis & eczema
4. Patients who have received any topical antifungal therapy within last 2 weeks or oral antifungal therapy in the previous 4 weeks
5. Participants not willing to give consent and to attend treatment schedule regularly
6. Patients with known active pulmonary/cardiovascular/ liver/ renal
or neurological diseases
7. Known cases of Diabetes Mellitus or other immunocompromised disorders (HIV/ AIDS, etc.)/ Malignancies
8. Patients with long-term history of steroid, cytotoxic and immunosuppressive therapy
9. History of hypersensitivity to either Terbinafine or any test drug
10. Pregnant or lactating women, and women desiring pregnancy |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in Total Signs & Symptoms Score (TSSS).
2. Change in mycology finding (KOH mount). |
TSSS at baseline, 2nd, 4th and 6th week
KOH mount at baseline and 42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.DLQI (Dermatology Life Quality Index)
2.Systemic Safety Assessment |
DLQI at baseline, 2nd, 4th and 6th week
Systemic Safety Assessment at baseline and 6th week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/06/2026 |
| 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 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
|
Tinea (ringworm) is a superficial fungal
infection caused by dermatophytes (Trichophyton, Microsporum, Epidermophyton),
commonly affecting keratinized tissues such as skin, hair, and nails. It is
highly prevalent in tropical and subtropical countries like India, with
significant social, emotional, and financial impact. Conventional antifungal
drugs are effective but associated with side effects (hepatotoxicity,
gastrointestinal upset, rashes, itching) often show resistance and limitations
in pregnant or vulnerable population.
Unani medicine describes several
formulations for Quba (dermatophytosis), including Roghan I Narjil,
Marham e Quba Habb e Quba , and others containing drugs with
pharmacological actions such as Musaffi Khun (blood purifier), Muhallil (resolvent), Jali(detergent), Mujaffif(desiccant), Dafa
I kharish (antipruritic), and Daf I Taffun(antiseptic). Many of these formulations are in clinical use but not
adequately evaluated scientifically.
Therefore, the present clinical trial is
designed as a Randomized, Parallel-group, Open-label, Active-controlled
study to evaluate the safety and efficacy of a Unani topical formulation
compared with topical terbinafine to provide a potentially safer, cost-effective,
and culturally acceptable alternative for managing Quba (tinea
corporis and tinea cruris) . |