Health Condition 1: null- VITILIGO Health Condition 2: L80- Vitiligo
Conditions
Interventions
Intervention1: UNIM-001 AND UNIM-003: UNIM-001 given orally according to per kg body body weight as mentioned in the protocol and UNIM003 given for topical application
Duration of treatment is 8 month
Sponsors
Central Council for Research in Unani Medicine CCRUM New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with clinically diagnosed dermatomal and non-dermatomal vitiligo 2. Subjects with 8 -50 years of age. 3. Either gender 4. With any duration of disease, site, extension and distribution of lesions 5. Willingness to give written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Subjects with active vitiligo treatment with other drugs/systems 2. Non-cooperative subjects 3. H/o of drug or alcohol abuse, chronic smokers not willing to abstain from smoking during the study period 4. Any clinically significant abnormality identified on physical examination or laboratory tests 5. Subjects having any systemic disease and other skin diseases. 6. Subjects with known allergies 7. Impaired Cardiac, Hepatic and Renal function 8. History of malignancy 9. Concomitant use of any other antioxidants 10. History of hypersensitivity to any of the investigational drugs/herbal medicine. 11. Receiving any other investigational product within 4 weeks 12. Any medical condition, where physician feels participation in the study could be detrimental to subjects well being. 13. Uncontrolled infection 14. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To study and ensure the cosmetically acceptable re- pigmentation with 40% to 50% increase in VASI Score 2 To determine the time of initial re-pigmentation and subsequently the rate of re-pigmentation. Timepoint: 8 MONTHS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 To evaluate the overall safety, toxicity, acceptability of Unani drugs. 2 To study the Post- treatment retention of re-pigmentation at least for 3 months. 3. To evaluate the % of study participants responding to the Unani treatment and psoralen. Timepoint: 8 MONTHS | — |
Countries
India
Contacts
Public ContactDr Abdul Hannan
Central Council for Research in Unani Medicine (CCRUM),
Outcome results
None listed