| CTRI Number |
CTRI/2022/07/044251 [Registered on: 22/07/2022] Trial Registered Prospectively |
| Last Modified On: |
21/07/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Unani formulation in Dark Spots on face. |
|
Scientific Title of Study
|
Efficacy of Rewandchini with Asl as Zimad in Kalaf (Melasma) - A Randomized Controlled Trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Wasima Swaleha |
| Designation |
PG Scholar |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Government Unani Medical College and Hospital Siddiaiah puranik road Basaweshwar nagar bangalore Government Unani Medical College and Hospital Siddiaiah puranik road Basaweshwar nagar bangalore Bangalore KARNATAKA 560079 India |
| Phone |
8088260712 |
| Fax |
|
| Email |
wasimaswaleha36@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nusrath Fathima |
| Designation |
Assistant Proffesor |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Government Unani Medical College and Hospital Siddiaiah puranik road Basaweshwar nagar bangalore Government Unani Medical College and Hospital Siddiaiah puranik road Basaweshwar nagar bangalore Bangalore KARNATAKA 560079 India |
| Phone |
7022317892 |
| Fax |
|
| Email |
drnusrathfarooque@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Wasima Swaleha |
| Designation |
PG Scholar |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Government Unani Medical College and Hospital Siddiaiah puranik road Basaweshwar nagar bangalore Government Unani Medical College and Hospital Siddiaiah puranik road Basaweshwar nagar bangalore Bangalore KARNATAKA 560006 India |
| Phone |
8088260712 |
| Fax |
|
| Email |
wasimaswaleha36@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goverrment Unani Medical College And Hospital bangalore |
|
|
Primary Sponsor
|
| Name |
Goverrment Unani Medical College And Hospital |
| Address |
Dept. of Moalajat, Government Unani Medical College and Hospital, 80 feet Rd, near Pavithra Paradise, Stage 1, Agrahara Dasarahalli, Basaveshwara nagar, Bengaluru-560079 |
| 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 Wasima Swaleha |
Government Unani College and Hospital, Bangalore |
33, 80 Feet Ring Rd, Stage 1, KHB Colony, Basaveshwar Nagar, Bengaluru, Karnataka 560079 Bangalore KARNATAKA |
8088260712
wasimaswaleha36@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Unani Medical and Hospital Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L814||Other melanin hyperpigmentation, (2) ICD-10 Condition: L814||Other melanin hyperpigmentation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Efficacy of Unani single drug Rewandchini |
Safoof of Rewandchini 2-3 gms with half teaspoon of asl prepared as zimad for local application in clinical trail on cases of kalaf melasma once in night for 20 minutes and then washed with normal water for 6 weeks |
| Comparator Agent |
hydroquinone 2 percent |
Local application of hydroquinone 2 percent in clinical trail on cases of kalaf melasma once in night for 20 minutes and then washed with normal water for 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Clinical patients of Kalaf (Melasma)
2 Patients of either sex
3 Patients between 18-50yrs of age
4 Patients with Fitzpatrick skin type III- type V
5 Patient m-MASI score up to 3 (Moderate/Marked) in darkness and ≤ 49% in Area
6 Duration of Melasma ≤ 3yrs
7 Willingness to participate in the study and follow the instructions
|
|
| ExclusionCriteria |
| Details |
1 Patients with any systemic illness and malignancies
2 Patients on contraceptive pills
3 Skin sensitivity
4 Severe cases of Melasma (m-MASI score >50%)
5 Pregnancy/ Lactating women
6 Hormonal replacement therapy
7 Topical bleaching agents for at least 1month or chemical peeling or laser at least 4months before the start of the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in kalaf melasma as per mMASI score and PGA score |
improvement in kalaf melasma as per mMASI score and PGA score on 7th 14th 21st 28th 35th 42nd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="37" Sample Size from India="37"
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)
|
25/07/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Melasma is common hypermelanosis that typically occurs on sun-exposed
areas in the face. The overall prevalence of Melasma in women varies by
geography and population between 1.5% and 33.3%. The estimated prevalence
of melasma in pregnant women is up to 70%. The prevalence of melasma in men as
suggested in one simple survey is approximately 20%. It is a cosmetic
issue that sometimes cause great psychological suffering. As per one study,
which showed that melasma associated with significant impact on health-related
quality of life. It is characterized by sharply demarcated, blotchy, brown
maculae, usually symmetrical on the cheeks, forehead, sometimes on the upper
lip and neck. According to Unani system factors affecting kalaf includes
frequent exposure to excess abnormal external heat; Dam-e-Muharraq (charred
blood), Sauda-e-Muharraq (charred melancholic blood), Ghiza-e-Kaseef (indigestible
food), constant local pressure, pregnancy, liver disease i.e. Du’f
al-kabid (liver atony) and Sughà r al-kabid. Although Melasma is
asymptomatic it is disfiguring skin disease that has a negative impact on life
and the self-esteem of effected individuals and causes distress in the patients
as it mainly affects the face. It affects their psychological and
emotional wellbeing and often feel bothered, frustrated, embarrassed, and
depressed about their skin appearance.
The physician described various regimenal and pharmacotherapies for the
management of Melasma in detail. The Pharmacological action of zimad in
present study exhibits: Jali (detergent), qabiz (astringent), Qasir (Scaling), Ghassal (irrigator), Mubassir (vesicant), Muhammir (rubifecient), Raade-Mawaad (divergent), Mughazzi (nutrient), muhalil-e-awram (anti-inflammatory),
antioxidant, antimicrobial, dafa-e-quba (antifungal), mana-e-sartan (anticancer), mana-e-qurooh (antiulcer)
properties.
Therefore a clinical trial entitled ’Efficacy of Rewandchini with Asl as Zimad in Kalaf (Melasma)
- A Randomized controlled trial’ is contemplated to evaluate the efficacy
of rewandchini with Asl with the objective of improvement in skin lesions and
to improve the quality of life of the sufferers of Melasma.
|