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 Baraṣ (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
|
|
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
|
|
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 Baraṣ (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. |