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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/05/008583
• Date of registration: 17-05-2017
• Prospective Registration: No
• Primary sponsor: Ayothidoss pandithar hospital
• Public title: Clinical evaluation of siddha drug Seenthil choornam (internal) and Puzhuvettuthylam (external) in the treatment of Alopecia areata in children.
• Scientific title: Clinical evaluation of siddha drug Seenthil choornam(internal) and Puzhuvettu thylam(external) in the treatment of Puzhuvettu (alopecia areata) in children on open clinical study - Alopecia
• Date of first enrolment: 02-01-2017
• Target sample size: 10
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18649
• Study type: Interventional
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Dr M Meenakshi sundaram
• Affiliation: National Institute of Siddha

• Name: Dr M Meenakshi sundaram
• Affiliation: National Institute of Siddha

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Alopecia areata

Intervention(s)

Intervention1: Seenthil choornam(internal) and Puzhuvettu thylam (external): 350-700 mg bd with sugar for 45 days and Puzhuvettu thylam
for external apply
Control Intervention1: nil: nil

Primary Outcome(s)

Primary outcome is mainly assessed by severity of Alopecia tool score(SALT SCORE)Timepoint: 45 days

Secondary Outcome(s)

Secondary outcome is assessed by comparing the following parameters before and after the treatment

1) Improvement in clinical symptoms

2) Any changes in before and after photographs.

Timepoint: 45 days

Secondary ID(s)

Nil

Source(s) of Monetary Support

Ayothidoss pandithar hospital National institute of siddha Tambaram sanatorium chennai-47

Ethics review

Status: Approved
Approval date: 20/05/2016
Contact:

Institutional ethics committee