| CTRI Number |
CTRI/2025/05/087906 [Registered on: 30/05/2025] Trial Registered Prospectively |
| Last Modified On: |
28/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [Topical Drug] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Evaluate the Effectiveness of a Topical Unani Formulation Compared to Luliconazole 1 Percent Ointment in Treating Bahaq (Pityriasis Versicolor) |
|
Scientific Title of Study
|
Therapeutic Evaluation of a Topical Unani Formulation in Pityriasis Versicolor (Bahaq) and Its Comparative Study with Luliconazole 1 Percent Ointment: A Randomized, Parallel Group, Open-Label, Standard-Controlled 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 Mehsan Barawaz |
| Designation |
PG Scholar |
| Affiliation |
Government Nizamia Tibbi College and General Hospital |
| Address |
OPD Room No. 122, PG Department of Moalajat, General Medicine, Government Nizamia Tibbi College and General Hospital, Charminar
Hyderabad
TELANGANA
500002
India |
| Phone |
9346061003 |
| Fax |
|
| Email |
mehsanbarawaz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shahbaz Ahmed |
| Designation |
Professor |
| Affiliation |
Government Nizamia Tibbi College and General Hospital |
| Address |
OPD Room No. 122, PG Department of Moalajat, General Medicine, Government Nizamia Tibbi College and General Hospital, Charminar
Hyderabad
TELANGANA
500002
India |
| Phone |
9848195067 |
| Fax |
|
| Email |
ahmedfarhath66@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shahbaz Ahmed |
| Designation |
Professor |
| Affiliation |
Government Nizamia Tibbi College and General Hospital |
| Address |
OPD Room No. 122, PG Department of Moalajat, General Medicine, Government Nizamia Tibbi College and General Hospital, Charminar
Hyderabad
TELANGANA
500002
India |
| Phone |
9848195067 |
| Fax |
|
| Email |
ahmedfarhath66@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Nizamia Tibbi College and General Hospital, Charminar, Hyderabad, Telangana State, 500002, India |
|
|
Primary Sponsor
|
| Name |
Government Nizamia Tibbi College and General Hospital |
| Address |
Government Nizamia Tibbi College and General Hospital Charminar, Hyderabad, Telangana, 500002 |
| 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 Mehsan Barawaz |
Government Nizamia Tibbi College and General Hospital, Charminar |
OPD Room No. 122, PG Department of Moalajat, General Medicine
Hyderabad
TELANGANA |
9346061003
mehsanbarawaz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Nizamia Tibbi College, Hyderabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B360||Pityriasis versicolor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A Topical Unani Formulation |
Composition: Phitakri (Alum) Hartal (Arsenic disulhate) Gandhak (Sulphur) kharbaq (helleborusniger) topical, after mixing the powder in vinegar.
Dosage of Drug: As per requirement twice in a day
Duration: 45 days. |
| Comparator Agent |
Luliconazole |
Luliconazole 1 Percent Ointment
Topical Application
Duration: 45 days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Age group above 16 to 45 years
Sex: Both males & females
Patient with any of the sign and symptoms of Bahaq (Pityriasis Versicolor) Hyper pigmented macule, Erythema, Pruritus on the lesion, Scaling / Desquamation.
Presence of Malassezia furfur in the scrapings of the lesion |
|
| ExclusionCriteria |
| Details |
Patient with serious co-morbid medical condition and other fungal infection
Participant who had received any systemic or topical antimycotic therapy within month of start of study
Significant Pulmonary/Cardiovascular/ Hepato-renal Dysfunction Known cases of Immunocompromised states (HIV, AIDS, etc.) Malignancies
Patient not willing to attend treatment schedule regularly
Person, Individual with any active Psychiatric illness
KoH mount test negative |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mycological cure rate of KOH examination of skin scrap (Direct Microscopy) at the end of 45 days. |
45 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in subjective parameters (Hypopigmentation, Scaling & Itching) of skin lesions evaluated by
an arbitrary grading scale, Total Sign & Symptom Score (TSSS) assessed on four point scale (0 absent, 1 mild, 2 moderate, 3 severe) |
45 Days |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
16/06/2025 |
| 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 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
|
Bahaq (Pityriasis versicolor) is a superficial fungal infection caused by Malassezia furfur, commonly affecting young adults. Though effective treatments exist in conventional medicine, challenges persist due to frequent recurrences, pigmentary changes, and potential side effects of oral antifungals, including hepatotoxicity and rare cardiac complications. The condition often leads to cosmetic concerns and emotional distress. Unani medicine has long used herbomineral remedies for Bahaq, but lacks scientific validation. This study aims to evaluate the safety and efficacy of a topical Unani formulation in managing Bahaq Aswad using modern clinical tools. |