| CTRI Number |
CTRI/2025/02/080222 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Preventive
Screening
Behavioral
Other (Specify) [Therapeutic efficacy] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study To Assess The Safety And Efficacy Of a Topical Unani Medicine For Quba (Tinea corporis), Comparing It to Standard Treatments To Explore a Natural, Effective Option For Fungal Skin Infections. |
|
Scientific Title of Study
|
A Randomized , Parallel group , Open label , Active Controlled Clinical Study To Evaluate The Safety and Efficacy of a Topical Unani Formulation In the Management of Quba (Tinea corporis). |
| 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 ANISUR REHMAN SHAIKH |
| Designation |
PG Scholar |
| Affiliation |
National Research Institute Of Unani Medicine For Skin Disorders |
| Address |
Department Of Moalajat
National Research Institute Of Unani Medicine For Skin Disorders A.G. Colony Road Opposite ESI Hospital, Erragadda Hyderabad-500038.
TELANGANA
500038
India
Hyderabad
TELANGANA
500038
India |
| Phone |
8976745320 |
| Fax |
|
| Email |
anisurrehmanshaikh94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARZEENA JABEEN |
| Designation |
Professor & principal |
| Affiliation |
National Research Institute Of Unani Medicine For Skin Disorders |
| Address |
Department Of Moalajat, National Research Institute Of Unani Medicine For Skin Disorders, A.G. Colony Rd., Opposite ESI Hospital, Errgadda, Hyderabad-500038.
Hyderabad
TELANGANA
500038
India
Hyderabad
TELANGANA
500038
India |
| Phone |
9032519286 |
| Fax |
|
| Email |
aarzu763@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANISUR REHMAN SHAIKH |
| Designation |
PG Scholar |
| Affiliation |
|
| Address |
Department Of Moalajat
National Research Institute Of Unani Medicine For Skin Disorders A.G. Colony Road Opposite ESI Hospital, Erragadda Hyderabad-500038.
TELANGANA
500038
India
Department Of Moalajat, National Research Institute Of Unani
Medicine For Skin Disorders, A.G. Colony Rd., Opposite ESI
Hospital, Errgadda, Hyderabad-500038.
Hyderabad
TELANGANA
500038
India
Hyderabad
TELANGANA
500038
India |
| Phone |
8976745320 |
| Fax |
|
| Email |
anisurrehmanshaikh94@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Research Institute Of Unani Medicine For Skin Disorders |
|
|
Primary Sponsor
|
| Name |
National Research Institute of Unani Medicine for Skin Disorders, Hyderabad |
| Address |
A.G. Colony Road, Opposite ESI Hospital, Erragadda,
Hyderabad-500038 |
| 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 ANISUR REHMAN SHAIKH |
National Reasearch Institute Of Unani Medicine For skin Disorders |
OPD & IPD of
Department Of
Moalajat, National
Research Institute Of
Unani Medicine For
Skin Disorders. A.G.
Colony Road, Opposite
ESI Hospital,
Erragadda,
Hyderabad-500038
Hyderabad
TELANGANA
Hyderabad
TELANGANA |
08976745320
anisurrehmanshaikh94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| COMMUNICATION OF DECISION OF INSTITUTIONAL ETHICS COMMITTEE (IEC) |
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 |
Clotrimazole 1% |
Dosage Form: 1% cream Route of Administration: Topical Application Dosage: Cream will be applied topically on the affected site twice daily for 6 weeks |
| Intervention |
Topical Unani Formulation (homogeneous powder as paste in buttermilk) |
Composition:Babchi seed(psoralea
seeds)Ghhongchi(crab’s eye)Sarso(black mustard)Kuth (Qust)Tukhm-i-panwad (foetid cassia)Dose:as per requirement twice daily mode of administraration Topical Duration of therapy :6week |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Individuals with circumscribed lesions on the body and limbs, presenting with any of the following signs and symptoms:
Pruritus and burning sensation
Presence of scales
Central clearing of the lesion
Erythematous papules
2 Additionally, participants must have a positive KOH (10%) smear microscopy from a skin scraping of the active lesion, confirming the presence of dermatophytic hyphae. |
|
| ExclusionCriteria |
| Details |
1 Age below 18 years and above 60 years.
2 Patients with other form of tinea infection like,tinea capitis, tinea pedis, tinea manuum, tinea unguium, tinea barbae tinea faciei, etc.
3 Patient 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 Patients with known active pulmonary/ cardiovascular/ liver/ renal or neurological diseases.
6 Known cases of Diabetes Mellitus or other immunocompromised disorders (HIV/ AIDS, etc.)/ Malignancies.
7 Patients with long-term history of steroid, cytotoxic and immunosuppressive therapy.
8 History of hypersensitivity to either clotrimazole or unani formulation.
9 Pregnant or lactating women, and women desiring pregnancy.
10 Participants not willing to give consent and to attend treatment schedule regularly.
|
|
|
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. Total Signs & Symptoms Score (TSSS)
(Clinical Cure)
2. Conversion to Negative Mycology
(Mycological Cure)
3. DLQI (Dermatology Life Quality Index |
TSSS at Baseline 2nd, 4th and 6th wees.
Mycological cure at baseline and on 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
DLQI (Dermatology Life Quality Index)
Systemic Safety assessment |
At baseline 2nd, 4th & 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)
|
01/07/2025 |
| 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
|
Dermatophytes are fungi responsible for tinea (ringworm) infections, affecting the hair, nails, and skin’s keratin layer. These infections are prevalent globally, particularly in tropical and subtropical regions, and are caused by fungi from three genera: Trichophyton, Microsporum, and Epidermophyton. Dermatophyte infections often result in annular skin lesions and can cause significant social, psychological, and economic issues in developing countries.
The treatment of dermatophyte infections can be challenging, especially with rising treatment failure rates. Common antifungal medications like chlorhexidine, itraconazole, and fluconazole can have severe side effects, particularly in pregnant women and children.
Traditional Unani medicine offers alternative treatments using formulations that contain ingredients like sulfur, copper sulfate, and borax, known for their anti-inflammatory, antiseptic, and blood-purifying properties. A clinical trial is underway to assess the safety and effectiveness of a topical Unani formulation for managing tinea corporis, as many of these treatments have yet to be scientifically evaluated. |