Health Condition 1: L80- Vitiligo
Conditions
Interventions
Intervention1: UNIM 001
UNIM 003
UNIM 001 placebo
UNIM 003 Placebo
NB UVB Therapy: All the selected subject will be divided into three groups. Group I will receive UNIM-001 oral twice in days in the d
Sponsors
Central Council for research in Unani Medicine
Eligibility
Inclusion criteria
Inclusion criteria: Patients with clinically diagnosed segmental and non-dermatomal vitiligo. Subjects with 12 -60 years of age. Either gender. With any duration of disease, site, extension and distribution of lesions. Willingness to give written informed consent form.
Exclusion criteria
Exclusion criteria: Subjects with active vitiligo treatment with other drugs/systems Non-cooperative subjects. H/o of drug or alcohol abuse, chronic smokers not willing to abstain from smoking during the study period. Any clinically significant abnormality identified on physical examination or laboratory tests. Subjects having any systemic disease and other skin diseases. Subjects with known allergies. Impaired Cardiac, Hepatic and Renal function. History of malignancy. Concomitant use of any other antioxidants. History of hypersensitivity to any of the investigational drugs/herbal medicine. Receiving any other investigational product within 4 weeks. Any medical condition, where physician feels participation in the study could be detrimental to subjects well being. Uncontrolled infection. Pregnant and lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| State of immunity before and after treatment through cytokine analysis IFN gamma IL 10 IL 6, IL1beta and TNF alpha State of oxidative stress before and after treatment through Lipid peroxidation superoxide dismutase nitric oxide catalase and reactive oxygen species. State of Vitamin D in the baseline.Timepoint: To study and ensure the cosmetically acceptable repigmentation with 40 percent to 50 percent decrease in VASI Score To evaluate the overall safety toxicity acceptability of unani coded drugs. To evaluate the decrease in the treatment duration with the NB UVB Therapy. To study the state of immunity and oxidative stress in pre and post treatment cases along with the vitamin D at baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the state of immunity before and after treatment in cases of vitiligo Baras along with the NB UVB therapy through the biochemical markers eg Th1 through IFN gamma Th2 through IL 10 and Th 17 through IL-6 IL 1 beta and TNF alpha and inflammatory markers as IFN gamma and TNF alpha. To evaluate the oxidative stress Lipid peroxidation superoxide dismutase nitric oxide catalase and reactive oxygen species State of Vitamin D in the baseline of vitiligo cases.Timepoint: To study and ensure the cosmetically acceptable repigmentation with 40 percent to 50 percent decrease in VASI Score To evaluate the overall safety toxicity acceptability of unani coded drugs. To evaluate the decrease in the treatment duration with the NB UVB Therapy. To study the state of immunity and oxidative stress in pre and post treatment cases along with the vitamin D at baseline. | — |
Countries
India
Contacts
Public ContactDr Misbahuddin Azhar
Regional Research Institute of Unani Medicine
Outcome results
None listed