FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/04/018669 [Registered on: 18/04/2019] Trial Registered Prospectively
Last Modified On: 09/04/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study of Unani drug in comparison to conventional drug in the treatment of vitiligo (white patches) 
Scientific Title of Study   A Single Blind, Randomized, Parallel Group, Controlled Clinical Study to compare the Efficacy and Safety of a Unani Drug – Atrilal (O and T) with Conventional Drug – Psoralen (O and T) in the Treatment of Baraá¹£ (Vitiligo) 
Trial Acronym  MVIT 
Secondary IDs if Any  
Secondary ID  Identifier 
B/V/A-P/RCT/CCRUM/17-18 Version: 01  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mozakkir Husain 
Designation  PG Scholar 
Affiliation  Central Research Institute of Unani Medicine 
Address  8-3-168/A/1/UM, Central Research Institute of Unani Medicine, A.Gs Colony Road, Erragadda

Hyderabad
TELANGANA
500038
India 
Phone  8859109398  
Fax    
Email  khan93b@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Qamar Uddin 
Designation  Professor & HoD Moalajat 
Affiliation  Central Research Institute of Unani Medicine 
Address  8-3-168/A/1/UM, Central Research Institute of Unani Medicine, A.Gs Colony Road, Erragadda

Hyderabad
TELANGANA
500038
India 
Phone  8700027178  
Fax    
Email  ccrumhqrsnd58@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mohammad Nawab 
Designation  Reader 
Affiliation  Central Research Institute of Unani Medicine 
Address  8-3-168/A/1/UM, Central Research Institute of Unani Medicine, A.Gs Colony Road, Erragadda

Hyderabad
TELANGANA
500038
India 
Phone  8100992044  
Fax    
Email  ccrumnawab@gmail.com  
 
Source of Monetary or Material Support  
Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038 
 
Primary Sponsor  
Name  Central Research Institute of Unani Medicine 
Address  Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad, Telangana, 500038 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Mozakkir Husain  Central Research Institute of Unani Medicine  Deptt. of Moalajat, OPD no. 19, Ground floor, CRIUM, Opp. ESI Hospital, AG Colony Road, Erragadda
Hyderabad
TELANGANA 
8859109398

khan93b@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee CRIUM Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L80||Vitiligo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A: Atrilal (Oral and Topical)   Study drug Atrilal (Tablets and Powder) will be prepared in a single batch, according to the standard method described in National Formulary of Unani Medicine (NFUM), at GMP certified Pharmacy of CRIUM, Hyderabad Route of administration and application: Oral Atrilal- Patients will be advised to take 2 tablets (750 mg each) orally thrice daily with water an hour after meals. Topical Atrilal- Patients will also be advised to apply Atrilal powder mixed with vinegar topically on vitiliginous lesions on alternate days, 1-2 hours after oral dose of Atrilal in the morning followed by sun exposure. Sun Exposure: Lesions will be exposed to sunlight, 15-30 minutes after topical application of Atrilal. Timing of Sun Exposure: During summers: between 9 A.M. and 10 A.M., and during winters: between 10 A.M. and 11 A.M. Duration of Sun Exposure: Sun exposure will be initially for 5 minutes with increment of 1 minute every week, up to a maximum of 20 minutes.  
Comparator Agent  Group B (Oral and Topical PUVAsol Therapy)  Oral Methoxsalen (Melanocyl tablets 10 mg): Methoxsalen will be given on alternate days in the dose of 20-40 mg (Table-2) orally with water after meals, 1-2 hours before exposure to sunlight. If patient develops nausea or vomiting, medication will be administered 45 minutes after administration of an anti-emetic. If nausea or vomiting still persists, Methoxsalen will be administered in 2 divided doses 30 minutes apart. Plus Topical Methoxsalen (Melanocyl solution 1 percent): Patients will also be advised to carefully apply Methoxsalen (1 percent) solution topically on vitiliginous lesions, 1-2 hours after oral dose of Methoxsalen in the morning followed by sun exposure. Sun Exposure: Lesions will be exposed to sunlight, 15 minutes after topical application of Methoxsalen solution. Timing of Sun Exposure: between 11 A.M. and 3 P.M. Duration of Sun Exposure: Sun exposure will be initially for 5 minutes with increment of 2 minutes every 3rd sitting, up to a maximum of 30 minutes. If patient misses 1 regularly scheduled treatment, then he/ she will be asked to expose to sunlight for the previous duration. If more than one consecutive sessions are missed, then duration of sun exposure will be reduced by 2 minutes per session missed to a minimum of 5 minutes. Reactions: If patient complains of burning, intense erythema or blistering (signs of phototoxicity) after therapy, the affected area will not be retreated until these reactions subside. The subsequent exposure time will be reduced by 2 minutes and maintained on this till end of therapy. Protection to reduce side effects: Patients will be advised to use protective sun glasses, sunscreens, suitable clothing, and umbrella during direct exposure to sunlight for 24 hours after each treatment. Patients will be instructed to protect eyes, lips and other normally pigmented areas during exposure to sunlight.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Patients of any sex aged18-40 years
Non-segmental vitiligo with chronicity of 6 months to 2 years
Vitiligo involving more than equal to 2% body surface area (BSA)
Patients with less than 5 new lesions in the last month
Patients with less than 15 lesions in the last 3 months
Patients who have not taken systemic treatment in the last 4 weeks
Patients who have not taken topical treatment in the last 2 weeks
 
 
ExclusionCriteria 
Details  Patients aged less than 18 years or more than 40 years
Segmental vitiligo/ lip-tip or universal vitiligo/ vitiligo with leucotrichia
Non-Segmental vitiligo with chronicity of less than 6 months or more than 2 years
History of photosensitivity/ photo exaggerated dermatoses
Pregnant or Lactating Women
Significant Pulmonary/ Cardiovascular/ Hepato-renal Dysfunction
Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies (cutaneous or internal)
Patients not willing to attend treatment schedule regularly
Patients not having a suitable facility for sun exposure
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Vitiligo Area Severity Index (VASI)
Vitiligo Disease Activity (VIDA) Score
Global Assessment (PGA) on VAS
Investigators Global Assessment (IGA)
Photographic Assessment
 
VASI at baseline, 4th week, 8th week, 12th week and end of the 16 week REST at baseline and end of the trial  
 
Secondary Outcome  
Outcome  TimePoints 
Lab investigations (Hemogram, LFT, RFT, ECG, CXR, CUE,   At baseline, and end of the 16th week 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/05/2019 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Baras (Vitiligo) is a chronic depigmenting skin disorder that affects 1-2% of the world population. It involves a complex interaction of environmental and genetic factors leading to progressive destruction of melanocytes characterized by chalky or milky white lesions. There is strong evidence of genetic predisposition of Baras (Vitiligo) from monozygotic twins and family studies.

Baras (Vitiligo) may develop at any age; onset has been reported from birth to 81 years of age. The peak age of onset is between 10 and 30 years; in 50% of cases, lesions develop within the first two decades of life.

Baras (Vitiligo) causes cosmetic disfigurement in patients, which may significantly impair their quality of life (QoL). The social stigma and matrimonial discriminations are associated with Baras (Vitiligo). The everyday stress and stigma associated with Baras (Vitiligo) may have psychological consequences such as depression and negative self-image. Furthermore, many cultures assume that patients with depigmented areas of skin carry leprosy, and therefore those with Baraṣ (Vitiligo) may be thrown out of society, for example into an ‘untouchable’ class.

There is no safe and effective treatment for Baras (Vitiligo) available in any system of medicine to regain pigmentation. Treatment options available across the systems have their own limitations in offering relief to this cosmetic problem. The incidence of side effects is too high as reported both with topical as well as systemic therapy, at the same time, surgical options available are self-hazardous, unless disease becomes stable, and there is hardly any medication available in conventional medicine to control the disease process and to check the aggravation. The steroids and PUVA therapy which are usually employed for the above purpose are hepato-toxic and carcinogenic in the long-term use.  

There is a need to focus on two issues one is to arrest the disease process and the other is to induce re-pigmentation. So, there is an ample need to search for a safe and effective drug, which may induce cosmetically acceptable re-pigmentation and control the disease process.

Keeping in view the magnitude of the problem and the need to regain the cosmetically acceptable pigmentation, and based on recent reports which suggest the efficacy and safety of various single as well as compound Unani formulations in the management of  Baraá¹£ (Vitiligo), a clinical study titled “A Single-Blind, Randomized, Parallel Group, Controlled Clinical Study to compare the Efficacy and Safety of a Unani Drug – Atrilal (O+T) with Conventional Drug – Psoralen (O+T) in the Treatment of Baras (Vitiligo)” has been designed.

 
Close