A Study on the Concept of Skin Colour and to clinically evaluate the efficacy of an Ayurvedic formulation in Melasma

Phase 1

Completed

• Conditions: Melasma

• Registration Number: CTRI/2012/06/002729
• Lead Sponsor: PallaviG

Brief Summary

The clinical component of the study was a clinical study consisting of sample size of 35 patients of Vyanga (Melasma). All the patients were assigned to a single group .Different parameters were used as assessment criterias . They were Skin colour, Lesion colour, Skin texture-dryness/oilyness, Skin lustre, Number and Size of the lesions, Darkness, Area and Homogeneity of lesion, Itching, Burning sensation, MASI Score. Varnya Gana lepa was administered for 15 days followed by same duration of follow up. The different parameters of the study were observed and recorded before treatment, after treatment and after the follow-up. The results were analyzed statistically based on the scores obtained from MASI and other assessment parameters for statistical significance.

There was statistically highly significant improvement in the MASI Scores but in overall assessment 64.5% patients had mild improvement. Clinical improvement was more evident in Darkness parameter when compared to other parameters.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08-12
• Last Update Posted: 2013-09-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• 1.Patients with clinical signs of the disease Vyanga as per ayurvedic classics will be included.
• 2.Patients between age group of 16-60 years will be selected for the study.
• 3Patients irrespective of sex, religion, occupation, and chronicity will be selected for the study.

Exclusion Criteria

• 1.Hyperpigmentation caused due to any systematic disease like Addisons disease, Cushings syndrome and SLE.
• 2.Hyperpigmentation since birth like Neavus 3.Hyperpigmentation caused by tumor like malignant melanoma.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Area of involvement	15days & 30 days
Darkness of the lesion	15days & 30 days
Homogeneity of the lesion	15days & 30 days

Secondary Outcome Measures

Name	Time	Method
Skin /Lesion Colour	Texture (Dry/Oily)

Trial Locations

Locations (1)

Mysore; 🇮🇳 Mysore, KARNATAKA, India

Mysore

🇮🇳Mysore, KARNATAKA, India

Pallavi

Principal investigator

09844616528

drgpallavi@gmail.com