Clinical study to evaluate various biomarkers and effect of Unani formulations on these biomarkers in Vitiligo patients

Phase 3

Recruiting

• Conditions: Health Condition 1: null- VitiligoHealth Condition 2: L80- Vitiligo

• Registration Number: CTRI/2015/10/006275
• Lead Sponsor: Central Council for Research in Unani Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Patients with clinically diagnosed non-segmental generalized Vitiligo

2. Subjects with 18 -50 years of age.

3. Either gender

4. Willingness to give written informed consent form.

Exclusion Criteria

Vitiligo Subjects with treatment with other drugs/systems

2. Non-cooperative subjects

3. H/o of drug or alcohol abuse, smokers

4. Any clinically significant abnormality identified on physical

examination or laboratory tests

5. Subjects having any systemic disease and other skin diseases.

6. Subjects with known allergies

7. Impaired Cardiac, Hepatic and Renal function

8. History of malignancy

9. History of hypersensitivity to any of the investigational

drugs / herbal medicine.

11. Receiving any other investigational product from

minimum last 4 weeks.

12. Any medical condition, where physician feels participation in the study could be detrimental to subjects well being.

13. Uncontrolled infection

14. Pregnant and lactating women.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Comparison of biomarker levels between normal control and Vitiligo patients <br/ ><br>2. Change in the status of biomarker level before and after the treatment with Unani formulation <br/ ><br>Timepoint: 8 months

Secondary Outcome Measures

Name	Time	Method
Study of co-relation of level of biomarkers with the degree of disease condition of VitiligoTimepoint: 8 months