A SINGLE ARM CLINICAL STUDY TO EVALUATE THE EFFECT OF ELADIGANA CHOORNA ON CHLOASMA IN POSTPARTUM WOMEN
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Reduction in the severity of chloasma in terms of darkness, area, and homogeneity assessed through MASI Index score and Improvement of skin color assessed through Color probe of DermaLab combo.
Study Overview
Brief Summary
• Chloasma also known as Melasma or mask of pregnancy is a hyper pigmentary disorder. Most women get it on the face, neck, cheeks, chin, nose bridge, forehead and above the upper lip.Even though exact etiology of melasma is not identified, it can be due to sun exposure, hormonal changes during pregnancy and use of oral contraceptive pills.Prevalence of chloasma during pregnancy is 50% - 70% in 30 % of women it becomes permanent but it may disappear completely within 1 year followed by childbirth **with treatment.**The disfiguring appearance and easy visibility may result in reduced quality of life. Currently treatments are photoprotection, topical, oral therapies and procedures such as peelings, laser, and microneedlingThese treatments are not considered safe during pregnancy or postpartum as well as these treatments are not suitable for all types of skin. Acharya Haritha has explained vaivarnayta under astagarbhoupadrva so it can be correlated with chloasma . Patient who clears the sensitivity test for the study drug. Sensitivity test will be done on the recruitment day by applying Eladigana Choorna with lukewarm water over the neck area and observed for 20 minutes for any allergic reactions A sufficient quantity of Eladigana Choorna with lukewarm water will be mixed well and made into a paste.The patient will be asked to clean their face with Mudaga choorna and water.The Eladigana choorna which is made into the paste will be applied from medial to lateral direction over the hyperpigmented area. The lepa will be allowed to keep until it starts drying. After that, the patient will be asked to wash her face with lukewarm water and dry with a soft cotton cloth.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 19.00 Year(s) to 45.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Postpartum women with hyperpigmentation developed during pregnancy Age more then 19 yrs.
- •Patients who clear the sensitivity test Patient with MASI index score moreqthen 4.
Exclusion Criteria
- •Patient with any skin disease such as Psoriasis, Eczema, Skin cancer, wound in the hyper-pigmented area.
- •Patients who are allergic to the study drug.
- •Patient using any cosmetic products on the face Patient not willing to stop the usage of face wash, moisturizer, or any other skin products during the course of treatment.
Outcomes
Primary Outcomes
Reduction in the severity of chloasma in terms of darkness, area, and homogeneity assessed through MASI Index score and Improvement of skin color assessed through Color probe of DermaLab combo.
Time Frame: Day 1: Pre assessment screening and admission for the course of 2 weeks. | Day 15: post assessment and result
Secondary Outcomes
No secondary outcomes reported