Clinical study to evaluate the safety and efficacy of Safuf Bara? in Bara? (Vitiligo)
- Conditions
- Health Condition 1: L80- Vitiligo
- Registration Number
- CTRI/2024/04/065215
- Lead Sponsor
- ATIONAL RESEARCH INSTITUTE OF UNANI MEDICINE FOR SKIN DISORDERS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
The following patients will be included in the study:
1.Patients of any sex aged 18-60 years
2.Non-Segmental Vitiligo with Chronicity of 6
months to 2 years
3.Vitiligo involving more than 2% Body Surface Area (BSA)
4.Patients with less than 5 New Lesions in the last month
5.Patients with less than 15 lesions in the last 3 months
6.Patients who have not received systemic treatment within 4 weeks prior to study entry
7.Patients who have not received topical
treatment within 2 weeks prior to study entry
The following patients will be excluded: 1.Patients aged less than 18 years or more than 60 years
2. Segmental Vitiligo/ Lip-Tip Vitiligo/ Universal Vitiligo/ Vitiligo with Leucotrichia
3. Significant Pulmonary/ Cardiovascular/ Hepatorenal Dysfunction, and other Disorders requiring long-term treatment
4. Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies
5. Pregnant or Lactating Women Patient not willing to attend treatment schedule regularly
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Reduction in Vitiligo Area Scoring Index (VASI) <br/ ><br>Timepoint: 0,2,4 and 8 weeks
- Secondary Outcome Measures
Name Time Method 1. Vitiligo Impact Scale-22 (VIS- <br/ ><br>(Assessment of Patient’s Quality of Life) <br/ ><br>2. Improvement in Patient’s Global Assessment (PGA) on VAS <br/ ><br>3. Improvement in Investigators Global Assessment (IGA)Timepoint: 0 and 8 weeks