Clinical efficacy and safety of an allopathic treatment and a unani regime in vitiligo

Phase 3

Recruiting

• Conditions: VITILIGO

• Registration Number: CTRI/2016/03/006754
• Lead Sponsor: Central Council of Research in Unani Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-09
• Last Update Posted: 2016-03-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Subjects of either sex, aged 18-65 yrs.
• Vitiligo involving >2% body surface area.
• Subject with <5 new lesions in last 1 months.
• Subject with < 15 lesions in previous 3 months.
• No systemic treatment in the previous 4 weeks.
• No topical treatment in previous 2 weeks.

Exclusion Criteria

• Age < 18 years or > 65 years.
• Pregnant or lactating women.
• Segmental vitiligo, lip-tip, or universal vitiligo.
• Significant cardiac, pulmonary & hepato- renal dysfunction.
• History of photosensitivity/ photo exaggerated dermatoses and connective tissue diseases.
• Patients with immunocompromised states (including HIV/AIDS) or malignancies (cutaneous or internal).
• Patient unsure about attending treatment schedule regularly.
• Patients who do not have a suitable facility for sun exposure.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	at baseline, 4wk, 12wk, 20wk, 28wk, and 36wk
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
2.To evaluate the safety of combination of oral UNIM-004 and lotion UNIM-005 (Unani formulation) in treatment of vitiligo.	at baseline, 4wk, 12wk, 20wk, 28wk, and 36wk

Secondary Outcome Measures

Name	Time	Method
1.To compare the rapidity of response in vitiligo using Unani treatment vs Allopathic treatment.	at baseline, 4wk, 12wk, 20wk, 28wk, and 36wk

Trial Locations

Locations (1)

Dermatology OPD, AIIMS; 🇮🇳 South, DELHI, India

Dermatology OPD, AIIMS

🇮🇳South, DELHI, India

NEENA KHANNA

Principal investigator

011-26593636

neena_aiims@yahoo.com