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A Survey Study On Participants Of Vyanga With Special Reference To Melasma And Randomized Comparative Trial With Intervention Of Mukhavyangaroga Nashaka Arka And Arjuna Twak Lepa

Phase 2
Conditions
Health Condition 1: L819- Disorder of pigmentation, unspecified
Registration Number
CTRI/2024/07/070469
Lead Sponsor
ational Institute of Ayurveda
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Subjects with Fitzpatrick skin types III, IV and V presenting with the classical signs and symptoms of Vyanga will be selected.

Female subjects of childbearing potential using a reliable form of contraception during the course of the study excluding oral contraceptive pills at the time of the study or in the past 6 months (intrauterine device or condoms) or female of nonchildbearing potential (hysterectomy, bilateral ovariectomy or tubal section/ligation)

Female subjects of childbearing potential with a negative urine pregnancy test before inclusion in the study Patient willing to follow up.

Exclusion Criteria

Pregnant women, nursing mothers

Subjects having known chronic, contagious infectious disease, such as active tuberculosis, hepatitis B or C, HIV

Subjects suffering from other pigmentation disorders

Subject having used any cosmetic depigmenting agent within 2 weeks prior to inclusion

Subjects who have used a topical or inhaled corticosteroid or systemic steroids within 1 month prior to inclusion in the study

Subjects having used topical tretinoin within 3 months or topical hydroquinone within 6 months prior to inclusion

Subjects with history of endocrinopathies

Hyperpigmentation caused since birth like nevus of ota.

Hyperpigmentation caused by tumor like malignant melanoma, Known case of any active skin malignancy

Vyanga along with other Kushtha roga to be excluded.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Changes in mMASI –modified Melasma Area and Severity index in the patients of Vyanga (Melasma)Timepoint: Changes will be observed on day 0 and Day 60
Secondary Outcome Measures
NameTimeMethod
changes in Physician’s Global Assessment scale and Melasma Quality of Life (MELASQOL)Timepoint: Changes will be observed on day 0 and Day 60
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