Clinical evaluation of siddha drug Seenthil choornam (internal) and Puzhuvettuthylam (external) in the treatment of Alopecia areata in children.

Phase 3

Completed

• Conditions: Alopecia areata

• Registration Number: CTRI/2017/05/008583
• Lead Sponsor: Ayothidoss pandithar hospital

Brief Summary

It is the single non-randomized,open label trial to determine the efficacy of Seenthil choornam (internal) and Puzhuvettu thylam (external) prepared from herbal constitutents in the patients with Puzhuvettu (Alopecia areata). In this trial 10 patients will be recruited and the trial drug will be administered 350mg - 700mg Twice a day with sugar for a period of 45 days. During the trial period if any AE/SAE/SUSAR will be noticed and refered to pharmacovigilance department in NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitored by the research monitoring committee of NIS.  During this trial all the safety efficacy parameters will be recorded in the CRF.  After completion of the trial all the study related data will be analysed statistically. The outcome of this trial will be published in India Journal of Medical research.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-01
• Last Update Posted: 2017-05-18

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1)Scattered long hair within the bald area 2)Unscarring 3)The area of hair loss may tingle or be painful 4)Affecting region is small 5)Hair loss present on the patches 6)Patients who are satisfying minimum of 3-4 above mentioned symptoms 7)Patient willing to undergo routine blood investigation.

Exclusion Criteria

1. Loss of hair in the shape of a way at the circumference of the head 2) Scarring alopecia 3)In case of severe hair loss 4) Alopecia tottalis 5) Vitiligo 6)Atopic dermatitis 7) Thyroid disease 8)Down syndrome.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome is mainly assessed by severity of Alopecia tool score(SALT SCORE)	45 days

Secondary Outcome Measures

Name	Time	Method
Secondary outcome is assessed by comparing the following parameters before and after the treatment	1) Improvement in clinical symptoms

Trial Locations

Locations (1)

Ayothidoss Pandithar Hospital, National Institute of Siddha; 🇮🇳 Kancheepuram, TAMIL NADU, India

Ayothidoss Pandithar Hospital, National Institute of Siddha

🇮🇳Kancheepuram, TAMIL NADU, India

Dr M Bakkiyadevi

Principal investigator

9994627411

bakkiyadevim@gmail.com