Treatment of white patches with Unani formulations

Phase 2

Completed

Brief Summary: Vitiligo is a complex metabolic disorder characterized by loss of pigmentation which is polygenic in nature and mostly regarded as social stigma. The course of Vitiligo without treatment is unpredictable. As Vitiligo being most stubborn, resistant cosmetic problem, it needs more attention.

Skin sensitivity is genetically predisposed which is usually graded as most sensitive to resistant. Among the subjects with skin grade 1 and 2 the topical application of Unani formulation causes sensitivity problems which ranges from hyperemia, itching, burning, blister formation, etc., which needs formulation that can be well tolerated.

There is a need to focus on two issues one in combating the origin of disease and the other is to induce the re-pigmentation. The treatment options available across the systems have their own limitation in offering relief to this cosmetic problem. The incidence of side effects are too high as reported both with topical as well as systemic therapy, at the same time the surgical options available are self-hazardous unless disease become stable and there is hardly any medication available in the modern 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 prolong use.

Recruitment & Eligibility

Inclusion Criteria

Known cases of Vitiligo with any duration of disease, site, extension and distribution of vitiligenous lesions.
Either sex, age range 13â€“50 years, with or without family history.
Willingness to participate in the study and to give written informed consent.

Exclusion Criteria

Subjects having any systemic disease and other skin diseases.
Subjects with known allergies.
Impaired Cardiac, Hepatic and Renal function 4.
Use of any other medications of allopathic and alternative system origin for the disease.
Concomitant use of any other antioxidants 6.
History of hypersensitivity to any of the investigational drugs/herbal medicine.
Any medical condition, where physician feels participation in the study could be detrimental to subjects well being.
Pregnant and lactating women.

Primary Outcome Measures

Name	Time	Method
By observation and Digital photography.	Baseline, 1st month, 2nd month, 3rd month, 4th month, 5th month, and 6th month

Secondary Outcome Measures

Name	Time	Method
Pathological and Biochemical Investigations for safety measures.	Before treatment and after treatment

Locations (1): Central Research Institute of Unani Medicine
🇮🇳
Hyderabad, ANDHRA PRADESH, India
Central Research Institute of Unani Medicine
🇮🇳Hyderabad, ANDHRA PRADESH, India
Dr Farhat Jabeen
Principal investigator
9032280109
fjabeen244@gmail.com