| CTRI Number |
CTRI/2025/09/094063 [Registered on: 01/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Medical Device Unani |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Evaluation of efficacy of Polyherbal Formulation in the Management of Melasma. |
|
Scientific Title of Study
|
Evaluation of efficacy and safety of Unani formulation in the management of Kalf (Melasma): A Randomized Controlled Study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yougshi Ilahi |
| Designation |
PG Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar bypass road Bhopal Madhya Pradesh Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar bypass road Bhopal Madhya Pradesh Bhopal MADHYA PRADESH 462003 India |
| Phone |
9755316486 |
| Fax |
|
| Email |
yougshi0512@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Mohd Rizwan |
| Designation |
Lecturer |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar bypass road Bhopal Madhya Pradesh Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar bypass road Bhopal Madhya Pradesh 462003 Bhopal MADHYA PRADESH 462003 India |
| Phone |
7828550209 |
| Fax |
|
| Email |
mohddr@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Yougshi Ilahi |
| Designation |
P.G. Scholar |
| Affiliation |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal Madhya Pradesh Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal Madhya Pradesh 462003 Bhopal MADHYA PRADESH 462003 India |
| Phone |
9755316486 |
| Fax |
|
| Email |
yougshi0512@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal Madhya Pradesh Medical Science University Jabalpur 482003 Madhya Pradesh India |
|
|
Primary Sponsor
|
| Name |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
| Address |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar bypass road Bhopal Madhya Pradesh |
| 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 |
| Yougshi Ilahi |
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital |
OPD No. 5 Department of Amraze Jild Wa Tazeeniyat Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal MADHYA PRADESH |
9755316486
yougshi0512@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Hakim Sayed Ziaul Hasan Government Unani Medical College And Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L811||Chloasma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Glycolic Acid |
It will be subjected to topical Glycolic acid 6% cream to the affected area for overnight once a day for 6 weeks. |
| Intervention |
Zimad (topical Unani Formulation )+ Microdermabrasion |
It will be subjected to same Zimad Alsi+ Vinegar (topical Unani formulation) for local application to the affected area for 30 minutes once daily for 6 weeks and Microdermabrasion fortnightly. |
| Intervention |
Zimad (Topical Unani Formulation) |
It will be subjected to same Zimad Alsi + Vinegar topical Unani formulation for local application to the affected area for 30 minutes once daily for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients of all sexes between 18-50 years
Clinically diagnosed patient of Melasma
Female of reproductive age group agree to use acceptable form of birth control during study (except IUCD and hormonal contraception)
Patient willing to sign the informed consent and to complete the study
|
|
| ExclusionCriteria |
| Details |
Pregnant and lactating females
Females using OCP (oral contraceptive pills) IUCD and hormonal contraception
Patient having other skin diseases like acne dermatitis urticaria dermatophytosis
Patients who have a known history or clinically relevant allergy in particular to any component of study medication
Having systemic disorders such as hepatic and renal insufficiency endocrine disorders malignant or premalignant lesions immunodeficiency diseases neurological and cardiac disorders
Patient consuming alcohol or drug abuse
Patient have taken topical or systemic treatment of melasma for last one month
Patient receive any cosmetic procedure such as chemical peel laser ablation FRT or dermabrasion for last 3 months
Not willing to sign informed consent
|
|
|
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.Melasma severity index
2.Photography
3.Safety evaluation |
1.on day 0, 21, 42
2.on day 0, 42
3.on day 0, 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| MELASQOL (Melasma Quality of Life Scale) |
on Day 0, 42 |
|
|
Target Sample Size
|
Total Sample Size="51" Sample Size from India="51"
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)
|
15/09/2025 |
| 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 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
|
Melasma is a common skin disorder characterized by symmetrical brown patches on the face, especially on the cheeks, forehead, and upper lip. It affects both genders but is more prevalent in women of reproductive age with darker skin tones. The term melasma is derived from the Greek word melas meaning black. In Unani medicine, it is known as Kalf and is thought to be caused by the accumulation of melancholic blood beneath the skin. While the exact cause of melasma is unclear, contributing factors include genetics, sun exposure, pregnancy, and use of oral contraceptives or photosensitizing drugs. Conventional treatments involve topical agents like hydroquinone and chemical procedures such as peels and lasers. However, these methods often produce inconsistent results and may cause side effects like skin irritation or pigmentation. This study aims to scientifically evaluate a traditional Unani treatment Zimad made from powdered Alsi and sugarcane vinegar. Patients will be randomly divided into three groups Test Group A will use only Zimad Test Group B will use Zimad with microdermabrasion and the Control Group will use glycolic acid 6 percent cream. The goal is to assess the effectiveness and safety of Unani treatment as a cost effective and side effect free alternative for managing melasma. |