Phase II An open single group non randomized study on "Venpulli"(Vitiligo) to evaluate the official siddha formulation "Athimathura chooranam(Int)& Ayilpattai pattru (Ext) in children of Both sex aging between 5-12 years attending OPD at Anna hospital
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- It is mainly assessed by reduction in VASI score
Study Overview
Brief Summary
This is an phase II open single group non randomized study to evaluate the official siddha formulation Athimathura chooranam(Int)& Ayilpattai pattru (Ext) for venpulli (Vitiligo).The trial drug is given 0.5 - 1 gm twice a day for 48 days & Ayilpattai pattru externally for 48 days .Clinical trial conducted after conducting preclinical toxicity study. The trial drug Athimathura chooranam and Ayilpattai pattru is mentioned in Gunapadam Mooligai.During the trial ,study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 5.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •12 years Both Male and female children Hypo pigmented patches surrounded by hyper pigmented border present in any part of the body.
Exclusion Criteria
- •Age below 4 years Albinism Piebaldsim Depigmented patches occurred after burns Hypopigmented patches starts firstly in lips,Genital area Juveline diabetes with vitiligo.
Outcomes
Primary Outcomes
It is mainly assessed by reduction in VASI score
Time Frame: 48 days
Photos of the patient before and after treatment for the clinical improvement
Time Frame: 48 days
Secondary Outcomes
- It is assessed by comparing the safety parameters before and after treatment(48 days)