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CTRI Number  CTRI/2015/11/006385 [Registered on: 26/11/2015] Trial Registered Retrospectively
Last Modified On: 04/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   To evaluate the Safety and efficacy of Unani formulations Zimad e Bars in Kalaf (Melasma)  
Scientific Title of Study   Clinical Validation study on ŪnānÄ« Pharmacopoeial Formulation– Zimad e Bars in Kalaf (Melasma)  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
K/M/ZB CLNVAL/CCRUM 14-15 VERSION 1  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Rais UR Rahman  
Designation  Director General 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

West
DELHI
110058
India 
Phone  9313980776  
Fax  01128522965  
Email  drrahman002@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K M Siddiqui 
Designation  Deputy Director General 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

West
DELHI
110058
India 
Phone  9810161758  
Fax  01128522965  
Email  ccrum507@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pradeep Kumar 
Designation  Research Officer 
Affiliation  Central Council for Research in Unani Medicine (CCRUM) 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri

West
DELHI
110058
India 
Phone  8800263300  
Fax  01128522965  
Email  drpradeepkumar2001@gmail.com  
 
Source of Monetary or Material Support  
InfrastructuralSupport:1.Regional Research Institute of Unani Medicine, Chennai 2.Regional Research Institute of Unani Medicine Kolkata, 3. Clinical Research Unit Bhopal Monetary Support : Central Council for Research in Unani Medicine, New Delhi  
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine 
Address  Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi-110058. 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR AMIR FAISAL  Clinical Research Unit Bhopal   Department of Pharmacology, Gandhi Medical College Bhopal
Bhopal
MADHYA PRADESH 		 09827082483

dramir_faisal@yahoo.in 
DR MOHAMMAD NAWAB  Regional Research Institute of Unani Medicine Kolkata  79, CHITRANJAN AVENUE, KOLKATA
Kolkata
WEST BENGAL 		 08100992044

drnawab20022000@gmail.com 
Hkm Sheikh Nikhat Parveen  Regional Research Institute of Unani Medicine, Chennai   No.1, West Madha Church Road, Royapuram
Chennai
TAMIL NADU 		 09566255415

drnikhat.unani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Clinical Research Unit Bhopal  Submittted/Under Review 
Regional Research Institute of Unani Medicine Kolkata WEST BENGAL  Submittted/Under Review 
Regional Research Institute of Unani Medicine, Chennai TAMIL NADU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L811||Chloasma, Kalaf (Melasma),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
Intervention  Ointment Zimaad e Baras  Ointment Zimaad e Baras Local Application Q.S. Twice daily for 8 weeks 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Female Subjects with 18 to 65 years of age
The patient presenting anyone or all signs mentioned below.
1. Ill defined light brown to grey brown macules on Forehead
2. Ill defined light brown to grey brown macules in RMR
3. Ill defined light brown to grey brown macules in LMR
4. Ill defined light brown to grey brown macules on Chin
 
 
ExclusionCriteria 
Details  Patients with anyone of the following skin disease
• Bahaq Aswad (pitryasis nigra)
o Namash (Naevus).
o Barash (lentigo)
o Khīlān (mole)
o Nishanate Quruh
o Fitzpatrick skin type grade 1 & 2
• Any systemic disorder requiring long term treatment.
• Drug or alcohol addict
• Subjects with oral contraceptive pills (OCPs)
• Pregnant and lactating woman
• Those who refuse to avoid cosmetics during study period
Subject Selection
• Female subjects with 18 to 65 years of age
• The patient presenting anyone or all signs mentioned below.
1. Ill defined light brown to grey brown macules on Forehead
2. Ill defined light brown to grey brown macules in RMR
3. Ill defined light brown to grey brown macules in LMR
4. Ill defined light brown to grey brown macules on Chin
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in signs and symptoms of Zimad e Bars in Kalaf (Melasma)  8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Haematological and biochemical assessment for safety assessment  8 weeks 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   13/04/2015 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is designed as a multicentric open trial in patients with Zimad e Bars in Kalaf (Melasma). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at baseline, 1st, 2nd, 3rd and 4th final follow ups. Each follow up will be carried out at the interval of two weeks. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be eight weeks. . Laboratory parameters for safety assessment will be conducted at baseline and end of study. 

Composition of Zimaad e Baras:

S. No.

Ūnānī Name

Botanical Name

Weight

1.       

Bekh-e-Anjeer Dashti

Ficus carica Linn.

100 g

2.

Babchi

Psoralea corylifolia Linn.

100g

3.

Tukhm-e-Panwar

Cleome icosandra Linn. Syn. C. viscosa Linn.

100g

4.

Narkachoor

Zingiber zerumbet Rosc ex Smith

100g

5

Aab-e-Lemu

Citrus limon (Linn.) Burm.f.

Q.S.

 

 
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