| CTRI Number |
CTRI/2024/06/068821 [Registered on: 12/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [Management of Melasma] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial of Unani medicine in the disease of Melasma. |
|
Scientific Title of Study
|
A Single-blind Standard Controlled Randomized clinical trial of Unani formulation in the management of Kalaf (Melasma). |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Safiya Naiyar |
| Designation |
PG Scholar |
| Affiliation |
Ajmal Khan Tibbia College |
| Address |
Department of Amraz e Jild wa Zohrawiya
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9540345135 |
| Fax |
|
| Email |
drsnaiyar@gamil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MOHAMMAD MOHSIN |
| Designation |
Associate Professor |
| Affiliation |
Ajmal Khan Tibbia College |
| Address |
Department of Amraz e Jild wa Zohrawiya
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9412329198 |
| Fax |
|
| Email |
aqdas2005@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Safiya Naiyar |
| Designation |
PG Scholar |
| Affiliation |
Ajmal Khan Tibbia College |
| Address |
Department of Amraz e Jild wa Zohrawiya
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9540345135 |
| Fax |
|
| Email |
drsnaiyar@gamil.com |
|
|
Source of Monetary or Material Support
|
| Department of Amraz e Jild wa Zohrawiya AMU Aligarh Uttar Pradesh India 202002 |
|
|
Primary Sponsor
|
| Name |
DEPARTMENT OF AMRAZ E JILD WA ZOHRAWIYA |
| Address |
FACULTY OF UNANI MEDICINE AMU ALIGARH |
| 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 |
| SAFIYA NAIYAR |
Ajmal Khan Tibbia College and Hospital |
Department of Amraz e Jild wa Zohrawiya Faculty of Unani Medicine AMU Aligarh India 202002
Aligarh
UTTAR PRADESH |
9540345135
drsnaiyar@gamil.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Department of Amraz e Jild wa Zohrawiya |
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 |
Paste of 4% Hydroquinone |
Paste of 4% Hydroquinone for local application followed by 2mg sunscreen of SPF30 per cm sq of skin (every 2 hourly) for 6 weeks. |
| Intervention |
Paste of Rewand Chini |
Paste of Rewand Chini for local application followed by 2mg sunscreen of SPF30 per cm sq of skin (every 2 hourly) for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age- 18 years and above.
Both male and female patients.
All skin types (Fitzpatrick I to VI).
Patients who signed the written consent form.
Epidermal and mixed pattern of melasma.
|
|
| ExclusionCriteria |
| Details |
Patients below 18 years.
Patient with systemic disease eg: DM, Malignancy, Thyroid dysfunction, CKD, and TB (as per history and clinical examination).
History of hypersensitivity reaction to drugs.
Patients who were not willing to sign the consent form or remain absent during the study.
Pregnant and Lactating mothers.
Women who are on OCPs (progesterone).
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Modified Melasma Area and Severity Index score (mMASI score).
Melasma Quality of Life scale (MelasQoL)
Photographs (without using filters)
|
15th, 30th, 45th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fairness, Glow, and Shining |
15th, 30th, 45th day |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
15/07/2024 |
| 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
|
The objective of the study is to evaluate the efficacy and safety of Rewand Chini (Rheum emodi) in paste form for local application in the management of Kalaf (Melasma) |