| CTRI Number |
CTRI/2017/12/010998 [Registered on: 27/12/2017] Trial Registered Prospectively |
| Last Modified On: |
01/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study for effectiveness of Unani drugs in white patches (vitiligo) |
|
Scientific Title of Study
|
A Clinical Study to Evaluate the Efficacy and Safety of Habb-i Hindi (O) and Habb-i Baras (L) in the Management of Baras (Vitiligo) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nazim Husain |
| Designation |
PG Scholar |
| Affiliation |
Central Research Institute of Unani Medicine, Hyderabad |
| Address |
Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad
Hyderabad
ANDHRA PRADESH
500038
India |
| Phone |
8882078902 |
| Fax |
|
| Email |
nazimcrium@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Qamar Uddin |
| Designation |
Professor and HOD Moalajat |
| Affiliation |
Central Research Institute of Unani Medicine, Hyderabad |
| Address |
Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad
Hyderabad
ANDHRA PRADESH
500038
India |
| Phone |
8700027178 |
| Fax |
|
| Email |
ccrumhqrsnd58@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohammad Nawab |
| Designation |
Reader |
| Affiliation |
Central Research Institute of Unani Medicine, Hyderabad |
| Address |
Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad
Hyderabad
ANDHRA PRADESH
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 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 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 |
| Nazim Husain |
Central Research Institute of Unani Medicine |
Ground floor, Room no: 2 Deptt. of Moalajat, Central Research Institute of Unani Medicine, Opp. ESI Hospital, AG Colony Road, Erragadda, Hyderabad
Hyderabad
ANDHRA PRADESH |
8882078902
nazimcrium@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee CRIUM Hyderabad |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, (2) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group (A) Unani Drugs Habbi Hindi (Oral) and Habbi Baras (Local) |
Habbi Hindi: Patients will be advised to take 6 pills (500mg each) orally twice daily an hour after meals. Habbi Baras: Patients will also be advised to make a homogenous paste of Habbi Baras with the Arq of Zanjabil and apply locally on the depigmented skin lesion(s) on alternate days 1½-2½ hrs after oral drug intake in the morning followed by Sun exposure starting with 5 minutes with increments of 5 minutes every 4 weeks, up to a maximum of 15 minutes. The patients will be advised to take the Sun exposure between 07 to 08 a.m. during summers and 08 to 09 a.m. during winters. If patient misses drug intake of Unani drug for 8 consecutive days or 4 consecutive exposures of Sunlight, the patient will be withdrawn from study because of protocol deviation. |
| Comparator Agent |
Group (B) Active Control Group PUVA sol and Mometasone |
Patients will be given 8 MOP after meals on alternate days, in the dose of 20 to 40 mg followed by Sun exposure. If patient develops nausea/vomiting, medication will be administered in 2 divided doses 30 minutes apart. Sun Exposure: Lesions will be exposed to Sunlight 1½-2½ hrs after intake of 8MOP. Timing of Sun Exposure: between 07 a.m. and 09 a.m. Starting Sun Exposure: 5 minutes. Increment of Exposure: 2 minutes every 3rd sitting till patient develops mild erythema. If patient misses 1 regularly scheduled treatment, then he/she will be asked to expose to Sun 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 develops signs of photo toxicity (burning, intense erythema, blistering) after therapy, the affected area will not be retreated until the signs subsides. The subsequent exposure time will be reduced by 2 minutes and maintained on this until end of therapy. Protection to reduce side effects: Protective Sunglasses on the day of treatment and the next day. Protection from direct exposure to Sunlight by use of sunscreens, suitable clothing, and umbrella.
Patients will also be asked to apply mometasone on the lesions daily at night. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients of any sex in the age group between 18 and 40 Years Patients with NonSegmental Vitiligo (NSV), disease chronicity from 6 months to 2 years
Vitiligo involving more than 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 received systemic treatment within 4 weeks prior to study entry
Patients who have not received topical treatment within 2 weeks prior to study entry |
|
| ExclusionCriteria |
| Details |
Patients aged less than 18 years or more than 40 years
Pregnant or Lactating Women
Segmental Vitiligo (SV), liptip, or universal Vitiligo, or Vitiligo with leucotrichia
History of Photosensitivity/Photoexaggerated Dermatoses and Connective Tissue Diseases
Significant Pulmonary/Cardiovascular/Hepatorenal Dysfunction 6. Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies (Cutaneous or Internal)
Patient 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 |
| To compare relative efficacy of Unani drugs Habbi Hindi(o) and Habbi Baras(l) and Cmparator group PUVAsol and topical mometasone nonsegmental vitiligo by using VASI and VIDA Score To evaluate safety of Unani drugs Habbi Hindi(o) and Habbi Baras and comparator PUVAsol and topical mometasone Non segmental vitiligo |
At baseline 4wk 8wk 12wk and 16wk |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the improvement in quality of life in patients with vitiligo assessed by PGA on VAS and IGA |
At baseline 4wk 8wk 12wk and 16wk |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/02/2018 |
| Date of Study Completion (India) |
25/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Baras (Vitiligo) is a social stigma as well as a cosmetic problem characterized by milky, white, hypo pigmented, sharply demarcated macules, which affects about 1% to 2 % of the world population, and is prevalent more than 8% in some regions of India. Females are comparatively more affected than males because of social stigma. It is mostly seen in the
2nd and 3rd decades of life. It has a familial incidence of 25 to 30 %.
Vitiligo is a multifactorial, polygenic disorder, with a complex pathogenesis that is not yet well understood. Out of various propounded theories, some accepted suggestions are the autoimmune destruction of melanocytes, melanocytes adhesion, neurogenic damage, autotoxicity, etc.
At present, available medical treatments for Baras are psoralens, longwave ultraviolet radiation (PUVA) and corticosteroids. Surgical therapies include mini grafting, melanocytes transplantation, and micropigmentation, but all these treatments have their own limitations with local and general side effects such as giddiness, epigastric discomfort, severe photo toxicity or blister reaction, perilesional hyperpigmentation, pruritus, trichosis, premature aging, and xerosis.
In Unani Medicine, Baras is a well recognized disease entity and has been treated successfully since antiquity with various single and compound drugs. In recent years, various clinical trials have also been conducted to validate and confirm the claims of coded Unani drugs.
Hence, the present study titled “A Clinical Study to Evaluate the Efficacy and Safety of HabbÂi Hindi (O) and HabbÂi Baras (L) in the management of Baras (Vitiligo)†has been designed. |