| CTRI Number |
CTRI/2016/03/006754 [Registered on: 21/03/2016] Trial Registered Retrospectively |
| Last Modified On: |
18/03/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Clinical efficacy and safety of an allopathic treatment and a unani regime in vitiligo |
|
Scientific Title of Study
|
Comparison of clinical efficacy and safety of Unani therapy in the form of systemic UNIM 004 & topical UNIM 005 with sunlight and conventional allopathic therapy in form of PUVA sol and topical mometasone cream in the treatment of clinically stable vitiligo |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neena Khanna |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Deptt. Dermatology and Venereology All India Institute of Medical Sciences
New Delhi
DELHI
110029
India
Deptt. Dermatology and Venereology All India Institute of Medical Sciences
New Delhi
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
011-26593636 |
| Fax |
26588579 |
| Email |
neena_aiims@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neena Khanna |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Deptt. Dermatology and Venereology All India Institute of Medical Sciences
New Delhi
DELHI
110029
India
Deptt. Dermatology and Venereology All India Institute of Medical Sciences
New Delhi
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
011-26593636 |
| Fax |
26588579 |
| Email |
neena_aiims@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neena Khanna |
| Designation |
Professor |
| Affiliation |
AIIMS |
| Address |
Deptt. Dermatology and Venereology All India Institute of Medical Sciences
New Delhi
DELHI
110029
India
Deptt. Dermatology and Venereology All India Institute of Medical Sciences
New Delhi
DELHI
110029
India
South
DELHI
110029
India |
| Phone |
011-26593636 |
| Fax |
26588579 |
| Email |
neena_aiims@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Central Council of Research in Unani Medicine,Ministry of AYUSH |
|
|
Primary Sponsor
|
| Name |
Central Council of Research in Unani Medicine |
| Address |
Central Council of Research in Unani Medicine
61-65, Institutional Area
Opp. D-Block, Janakpuri
New Delhi – 110 058 |
| Type of Sponsor |
Government funding agency |
|
|
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 |
| NEENA KHANNA |
Dermatology OPD, AIIMS |
Deptt. Dermatology and Venereology All India Institute of Medical Sciences
South
DELHI |
011-26593636
91-11-26588579
neena_aiims@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
VITILIGO, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A (Study group, Unani medicine group)
UNIM-004(ORAL)
UNIM-005 (TOPICAL) |
Group A (Study group, Unani medicine group): Patients will be given:
UNIM-004: Patients will be asked to take 2 tablets (each containing 500mg of active ingredients) orally twice daily an hour after meals.The medication will be taken for 23 consecutive days followed by a gap of 5 days to circumvent side effects.
AND
UNIM-005: Patients will also be asked to apply UNIM-005 lotion on alternate days 1 ½ - 2 hours after oral drug intake in the morning followed by sunexposure starting with 5 minutes with increments of 5 minutes every 4 wk, upto a maximum of 15 minutes. The patients will be asked to time the sun exposure between 10 to 11 a.m. during winters and 9 to 10 a.m. during summers. If patient misses drug intake of unani medicine 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 group)
8 methoxypsoralen
Mometasone |
Group B (Active control group, PUVA sol group):Patients will be given:
8 methoxypsoralen (MOP): Patients will be given 8 MOP after meals on alternate days, in the dose of 20-40 mg followed by sun exposure. If patient develops nausea/vomiting, medication will be administered 45 minutes after administration of an antiemetic. If the nausea/ vomiting still persists, 8 MOP will be administered in 2 divided doses 30 minutes apart.
Sun exposure: Lesions will be exposed to sun light, 1 ½ -2 ½ hours after intake of 8MOP
Timing of sun exposure: between 11 AM and 3 PM.
Starting sun exposure: 5mins.
Increments of exposure: 2 min 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 2min per session missed to a minimum of 5 minutes.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects of either sex, aged 18-65 yrs.
2. Vitiligo involving >2% body surface area.
3. Subject with <5 new lesions in last 1 months.
4. Subject with < 15 lesions in previous 3 months.
5. No systemic treatment in the previous 4 weeks.
6. No topical treatment in previous 2 weeks.
|
|
| ExclusionCriteria |
| Details |
1. Age < 18 years or > 65 years.
2. Pregnant or lactating women.
3. Segmental vitiligo, lip-tip, or universal vitiligo.
4. Significant cardiac, pulmonary & hepato- renal dysfunction.
5. History of photosensitivity/ photo exaggerated dermatoses and connective tissue diseases.
6. Patients with immunocompromised states (including HIV/AIDS) or malignancies (cutaneous or internal).
7. Patient unsure about attending treatment schedule regularly.
8. Patients who do not have a suitable facility for sun exposure.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare relative efficacy of a combination of oral UNIM 004 and lotion UNIM-005 (Unani formulation) and oral PUVAsol and topical mometasone (standard allopathic therapy) in stable vitiligo.
2. To evaluate the safety of combination of oral UNIM-004 and lotion UNIM-005 (Unani formulation) in treatment of vitiligo.
3. To compare the improvement in quality of life in patients with vitiligo treated with the Unani combination vis-a vis the Allopathic combination.
|
at baseline, 4wk, 12wk, 20wk, 28wk, and 36wk
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the rapidity of response in vitiligo using Unani treatment vs Allopathic treatment. |
at baseline, 4wk, 12wk, 20wk, 28wk, and 36wk
|
|
|
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 3 |
|
Date of First Enrollment (India)
|
07/09/2015 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Vitiligo is a common disorder that causes patchy depigmentation and is often associated with immense psychosocial impact. Compounding this is the challenge of getting cosmetically acceptable pigmentation since the presently available treatment options are not only suboptimally effective but also do not give a good color match. Conventionally it is believed that the traditional systems of medicine have much to offer in treatment of vitiligo. Though there are a few reports of efficacy of Unani medicines (mostly in the form of CCRUM generated monograms) in the treatment of vitiligo (Baras), there is dearth of systemic evaluation of safety and efficacy of these drugs especially vis a vis allopathic treatment options available. |