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

Phase 3

Recruiting

• Conditions: Vitiligo. Ayurveda Condition: SVITRAH,

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

Brief Summary

This study is a single-arm, open-label, observational study.The sample size of the study is 81.Patients above the age of 18 will be enrolled. Participants will receive interventions for 6 months. The primary objective is to evaluate the efficacy and tolerability of 540 mg BID Melanogrit (Traditional Indian Ayurvedic Medicine) in patients with Leukoderma and secondary outcome is changes in the Vitiligo Extent Score (VES), Investigators Global Assessment (IGA), VIS-22, VitiQol and Global perceived treatment satisfaction from medication.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-23
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 81

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.

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.
• 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.
• 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.	Baseline, 12 weeks, 24 weeks

Secondary Outcome Measures

Name	Time	Method
•Changes in the Vitiligo Extent Score (VES), Investigators Global Assessment (IGA), VIS-22, VitiQol and Global perceived treatment satisfaction from medication.

Trial Locations

Locations (2)

Patanjali Wellness Center; 🇮🇳 Hardwar, UTTARANCHAL, India

Patanjali Yoggram; 🇮🇳 Hardwar, UTTARANCHAL, India

Patanjali Wellness Center

🇮🇳Hardwar, UTTARANCHAL, India

Dr Purva Soni

Principal investigator

8272068141

purvasoni92@gmail.com