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

Phase 3

• Conditions: Health Condition 1: null- VITILIGO

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 300

Inclusion Criteria

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.

Exclusion Criteria

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.

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. <br/ ><br>2.To evaluate the safety of combination of oral UNIM-004 and lotion UNIM-005 (Unani formulation) in treatment of vitiligo. <br/ ><br>3.To compare the improvement in quality of life in patients with vitiligo treated with the Unani combination vis-a vis the Allopathic combination. <br/ ><br>Timepoint: at baseline, 4wk, 12wk, 20wk, 28wk, and 36wk <br/ ><br>

Secondary Outcome Measures

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