To evaluate the efficacy of traditional Ayurvedic formulation (Divya Melanogrit) in Leukoderma.

Phase 3

• Conditions: Health Condition 1: L80- Vitiligo

• Registration Number: CTRI/2023/02/049953
• Lead Sponsor: Patanjali Research Institute governed by Patanjali Research Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 3 April 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Patients who are known cases of leukoderma (vitiligo).

2.Age should be minimum of 18 years.

3.Patient who is willing to participate voluntary and comply throughout the study process.

4.Informed consent must be obtained

Exclusion Criteria

CRITERIA FOR INCLUSION AND EXCLUSION

Inclusion criteria

1.Patients who are known cases of leukoderma (vitiligo).

2.Age should be minimum of 18 years.

3.Patient who is willing to participate voluntary and comply throughout the study process.

4.Informed consent must be obtained.

Exclusion criteria

1.Patients who do not fulfill inclusion criteria must be excluded.

2.Known cases of Psoriasis, eczema or any other skin allergies patients will be excluded.

3.Patients who are currently undergoing any restricted therapy like UV phototherapy, Tar therapy, topical photo chemotherapy, oral and topical corticosteroids, immunomodulators, etc. will be excluded.

4.Patients who are pregnant, lactating and those who plan to become pregnant within a year.

5.Those with a history of primary cardiovascular, respiratory, digestive, urinary, endocrinological and haematological diseases that cannot be controlled with ordinary treatments will be excluded.

6.Those with malignant diseases, infections, electrolyte imbalances and acid-base disturbances will be excluded.

7.Patients who are allergic to any medicine or ingredients used in this study will be excluded.

8.Patients who are consuming steroids during the study duration must be excluded.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effectiveness and tolerability of Divya Melanogrit in patients with Leukoderma.Timepoint: Baseline, 12 weeks, 24 weeks

Secondary Outcome Measures

Name	Time	Method
â?¢Changes in the Vitiligo Extent Score (VES), Investigators Global Assessment (IGA), VIS-22, VitiQol and Global perceived treatment satisfaction from medication. <br/ ><br> <br/ ><br>Timepoint: DAY 0, DAY 90,DAY 180