CTRI

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CTRI Number

CTRI/2017/05/008583 [Registered on: 17/05/2017] Trial Registered Retrospectively

Last Modified On:

18/05/2017

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Siddha

Study Design

Single Arm Study

Public Title of Study

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

Scientific Title of Study
Modification(s)

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

Trial Acronym

Alopecia

Secondary IDs if Any

Secondary ID	Identifier
Nil	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr M Bakkiyadevi
Designation	PG Scholar
Affiliation	National Institute of Siddha
Address	Department of Kuzhanthai maruthuvam, National institute of siddha, Tambaram Samnatorium. Department of Kuzhanthai maruthuvam, National institute of siddha, Tambaram Samnatorium. Kancheepuram TAMIL NADU 600047 India
Phone	9994627411
Fax
Email	bakkiyadevim@gmail.com

Details of Contact Person
Scientific Query

Name	Dr M Meenakshi sundaram
Designation	Associate professor Head of the Dept i/c
Affiliation	National Institute of Siddha
Address	Department of Kuzhanthai maruthuvam, National institute of siddha, Tambaram Samnatorium. Department of Kuzhanthai maruthuvam, National institute of siddha, Tambaram Samnatorium. Kancheepuram TAMIL NADU 600047 India
Phone	9444214582
Fax	04422381314
Email	mmssiddha@rediffmail.com

Details of Contact Person
Public Query

Name	Dr M Meenakshi sundaram
Designation	Associate professor Head of the Dept i/c
Affiliation	National Institute of Siddha
Address	Department of Kuzhanthai maruthuvam, National institute of siddha, Tambaram Samnatorium. Department of Kuzhanthai maruthuvam, National institute of siddha, Tambaram Samnatorium. TAMIL NADU 600047 India
Phone	9444214582
Fax	04422381314
Email	mmssiddha@rediffmail.com

Source of Monetary or Material Support

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

Primary Sponsor

Name	Ayothidoss pandithar hospital
Address	Natoinal institute of siddha Tambaram sanatorium.
Type of Sponsor	Research institution and hospital

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr M Bakkiyadevi	Ayothidoss Pandithar Hospital, National Institute of Siddha	OPD NO 9 and IPD,Department of Kuzhandhai maruthuvam, National institute of siddha, tambaram sanatorium Kancheepuram TAMIL NADU	9994627411 bakkiyadevim@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional ethics committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	Alopecia areata,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	nil	nil
Intervention	Seenthil choornam(internal) and Puzhuvettu thylam (external)	350-700 mg bd with sugar for 45 days and Puzhuvettu thylam for external apply

Inclusion Criteria

Age From	6.00 Year(s)
Age To	12.00 Year(s)
Gender	Both
Details	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.

ExclusionCriteria

Details

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

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Case Record Numbers

Blinding/Masking

Open Label

Primary Outcome

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

Secondary Outcome

Outcome	TimePoints
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.	45 days

Target Sample Size

Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)=""

Phase of Trial

Phase 3

Date of First Enrollment (India)

02/01/2017

Date of Study Completion (India)

Date Missing

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="0"
Months="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

None yet

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

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.