CTRI

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CTRI Number

CTRI/2016/08/007192 [Registered on: 17/08/2016] Trial Registered Retrospectively

Last Modified On:

19/11/2019

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Ayurveda
Diagnostic

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Unhealthy diet as a cause in development of skin disease and its treatment with some Ayurvedic drugs

Scientific Title of Study

Evaluation of Viruddha Ahara in the Pathogenesis of Kustha With Special Reference to VicharchikÄ And its Management In the Purview of, "Viruddha Ashanajan Rogan Pratihanti Virechanam"

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

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

Name	Manisha Talekar
Designation	PG Scholar
Affiliation	National Institute of Ayurveda jaipur
Address	PG Department of Roganidana evam Vikriti Vijnana NIA Jaipur PG Department of Roganidana evam Vikriti Vijnana NIA Jaipur Jaipur RAJASTHAN 302002 India
Phone
Fax
Email	dr.mani21jan@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Sisir Kumar mandal
Designation	Assistant Professor
Affiliation	National Institute of Ayurveda jaipur
Address	PG Department of Roganidana evam Vikriti Vijnana NIA Jaipur PG Department of Roganidana evam Vikriti Vijnana NIA Jaipur Jaipur RAJASTHAN 302002 India
Phone
Fax
Email	drskmandal2008@rediffmail.com

Details of Contact Person
Public Query

Name	Manisha Talekar
Designation	PG Scholar
Affiliation	National Institute of Ayurveda jaipur
Address	PG Department of Roganidana evam Vikriti Vijnana NIA Jaipur PG Department of Roganidana evam Vikriti Vijnana NIA Jaipur RAJASTHAN 302002 India
Phone
Fax
Email	dr.mani21jan@gmail.com

Source of Monetary or Material Support

Pharmacy Of Ntional Institute Of Ayurveda Jorawar Singh Gate Amer Road JAIPUR 302002 Rajasthan

Primary Sponsor

Name	National Institute of Ayurveda
Address	Jorawar singh Gate, Amer road Jaipur, 302002, Rajasthan
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
Manisha Talekar	National Institute of Ayurveda Jaipur	PG Department of Roganidana evam Vikriti Vijnana NIA Jaipur Jaipur RAJASTHAN	8824854303 dr.mani21jan@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Departmental Research Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied
Modification(s)

Health Type	Condition
Patients	(1) ICD-10 Condition: L309\|\|Dermatitis, unspecified, having sign and symptoms of vicharchika kustha,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Aragwadha patra lepa	Aragwadha patra lepa (leaves of Cassia fistula Linn.) along with Takra for local application in sufficient quantity as per area
Intervention	Trivrit Churna with Aragwadha patra lepa	Trivrit Churna (Operculina turpethum Linn.) 6 gm twice daily with Luke warm water for 1 Month. Aragwadha patra lepa (leaves of Cassia fistula Linn.) along with Takra for local application in sufficient quantity as per area

Inclusion Criteria

Age From	18.00 Year(s)
Age To	70.00 Year(s)
Gender	Both
Details	Patient with the classical sign and symptoms of VicarcikÄ Kuá¹£á¹ha viz Kaá¹‡á¸Å« RujÄ Piá¸ikÄ SrÄva Ruká¹£atÄ ÅšyÄva DÄha RÄjÄ« Patients above 18 years and below 70 years of age Patients belonging to either gender

ExclusionCriteria

Details

The patient suffering from systemic disorders
The pregnant women and lactating mother
Patient less than 18 years and above 70 yrs of age

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

An Open list of random numbers

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Developed Dietetic guidelines for the patients of Kustharoga and ointment formulation for these kind of patient	follow up at every 15 days total duration 1 month

Secondary Outcome

Outcome	TimePoints
Devoloped patient awareness about faulty dietary habits	1 month

Target Sample Size

Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60"

Phase of Trial

Phase 3

Date of First Enrollment (India)

13/01/2013

Date of Study Completion (India)

21/09/2014

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Date Missing

Estimated Duration of Trial

Years="2"
Months="1"
Days="10"

Recruitment Status of Trial (Global)
Modification(s)

Not Applicable

Recruitment Status of Trial (India)

Completed

Publication Details

yet to published

Individual Participant Data (IPD) Sharing Statement

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

Brief Summary

A randomised clinical trial has been designed to assess the efficacy of Trivá¹›ta CÅ«rá¹‡a with Ä€ragvadha Patra Lepa & Ä€ragvadha Patra Lepa alone in the management of VicarcikÄ (Eczema) 63 patients of VicarcikÄ Kuá¹£á¹ha were selected from O.P.D. of RoganidÄna evam Viká¹›ti VijÃ±Äna department of N.I.A. and randomly taken in 2 groups, out of which 60 patients (30 patients each) were completed the trial treatment. Group A received Trivá¹›ta CÅ«rá¹‡a with Ä€ragvadha Patra Lepa & Group B received Ä€ragvadha Patra Lepa alone for 4 weeks. All calculations were calculated through â€˜Graph Pad In stat 3â€™ software. Nitya Virecana (Regular purgation) by Trivá¹›ta along with Ä€ragvadha Patra Lepa (Group A) proved more effective to control Kaá¹‡á¸Å«, SrÄva, DÄha, Piá¸Ä«kÄ, Vaivará¹‡ya, RujÄ & Åšotha. The synergistic actions of Trivá¹›ta along with Ä€ragvadha Patra Lepa are likely to check the etio-pathogenesis of VicarcikÄ Kuá¹£á¹ha (Eczema) and arrest its progress.