CTRI RA Ay Med Guru Snigdha Guna of Kapha - Clin Higwadi Curna - Sunthyadi Kvath in Ama Vata

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CTRI Website URL - http://ctri.nic.in

Clinical Trial Details (PDF Generation Date :- Sun, 30 May 2021 08:15:08 GMT)

CTRI Number CTRI/2018/06/014492 [Registered on: 11/06/2018] - Trial Registered Prospectively


Last Modified On 07/06/2018
Post Graduate Thesis Yes
Type of Trial Interventional
Type of Study Drug
Ayurveda
Study Design Randomized, Parallel Group Trial
Public Title of Study effect of some ayurvedic medicine in Amavata (Rheumatoid Arthritis)
Scientific Title of A Physiological Study of Guru and Snigdha Guna of Kapha and their Applied Aspect with clinical
Study Assessment of Hingwadi Churna and Shunthyadi Kwath in Amavata
Secondary IDs if Any Secondary ID Identifier
NIL NIL
Details of Principal Details of Principal Investigator
Investigator or overall
Name Prof Om Prakash Dadhich
Trial Coordinator
(multi-center study) Designation Professor
Affiliation Naitional Institute of Ayurveda
Address Room number 226 PG Department of kriya sharir National Institute
of Ayurveda, Jaipur PG Department of kriya sharir National Institute
of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India
Phone 9829264232
Fax
Email [email protected]
Details Contact Details Contact Person (Scientific Query)
Person (Scientific
Name Prof Om Prakash Dadhich
Query)
Designation Professor
Affiliation Naitional Institute of Ayurveda
Address Room number 226 PG Department of kriya sharir National Institute
of Ayurveda, Jaipur PG Department of kriya sharir National Institute
of Ayurveda, Jaipur
Jaipur
RAJASTHAN
302002
India
Phone 9829264232
Fax
Email [email protected]
Details Contact Details Contact Person (Public Query)
Person (Public Query)
Name Prof Om Prakash Dadhich
Designation Professor
Affiliation Naitional Institute of Ayurveda
Address Room number 226 PG Department of kriya sharir National Institute
of Ayurveda, Jaipur PG Department of kriya sharir National Institute
of Ayurveda, Jaipur
Jaipur
RAJASTHAN

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PDF of Trial
CTRI Website URL - http://ctri.nic.in

302002
India
Phone 9829264232
Fax
Email [email protected]
Source of Monetary or Source of Monetary or Material Support
Material Support
> National Institute of Ayurveda jorawar singh gate Jaipur 302002
Primary Sponsor Primary Sponsor Details
Name National Institute of Ayurveda jaipur
Address National Institute of Ayurveda jorawar singh gate Jaipur 302002
Type of Sponsor Research institution and hospital
Details of Secondary Name Address
Sponsor
NIL NIL
Countries of List of Countries
Recruitment
India
Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email
Investigator
Dr Neeti Agrawal National Institute of Sharir kriya opd, room 8004701051
Ayurveda hospital no.3 National Institute
Jaipur of Ayurveda hospital dr.agrawalneeti@gmail.
Jorawar singh gate com
Jaipur 302002
Jaipur
RAJASTHAN
Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics
Committee Committee?
Institutional Ethics Approved 25/04/2017 Yes
Committee National
Institute of Ayurveda
Jaipur
Regulatory Clearance Status Date
Status from DCGI
Not Applicable No Date Specified
Health Condition / Health Type Condition
Problems Studied
Patients patient suffer from amavata (rheumatoid arthritis)
Intervention / Type Name Details
Comparator Agent
Intervention hingwadi churna 3gm twice a Hingu Chavya Vida Lavana
day orally for 45 days. Shunthi Pippali Krishna jeerak
Pushkar
Comparator Agent shunthyadi kwath 30ml twice in Shunthi Gokshura
a day orally for 45 days.
Inclusion Criteria Inclusion Criteria
Age From 16.00 Year(s)
Age To 70.00 Year(s)
Gender Both
Details Inclusion criteria:-<br/> 1.Diagnosed & confirmed cases of Amavata
as per classical symptoms and other criteria.<br/> 2.Patient of either
male or female between the age group of 16 to 70 years.<br/>
3.Patient who are willing to take medicine.<br/> 4.Patient willing to
sign the consent form.<br/>
Exclusion Criteria Exclusion Criteria

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PDF of Trial
CTRI Website URL - http://ctri.nic.in

Details Exclusion criteria:-


1.Patient of age below 16 years and above 70 years.
2.Patient of Amavata with severe crippling deformities.
3.Patient suffering from any major systemic diseases like Diabetes
mellitus,TB etc.
4.Patient with other joint disorders like Osteoarthritis, Gout, psoriatic
arthritis etc.

Method of Generating Coin toss, Lottery, toss of dice, shuffling cards etc
Random Sequence
Method of An Open list of random numbers
Concealment
Blinding/Masking Open Label
Primary Outcome Outcome Timepoints
to treat amavata one year
Secondary Outcome Outcome Timepoints
Grading will be done on the basis of sign and one year
symptoms of Amavata mentioned in Ayurveda
texts.
Target Sample Size Total Sample Size=30
Sample Size from India=30
Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials
Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials
Phase of Trial Phase 1/ Phase 2
Date of First 15/06/2018
Enrollment (India)
Date of First No Date Specified
Enrollment (Global)
Estimated Duration of Years=0
Trial Months=6
Days=0
Recruitment Status of Not Applicable
Trial (Global)
Recruitment Status of Not Yet Recruiting
Trial (India)
Publication Details NIL
Brief Summary This trial entitled as A Physiological Study Of Guru & Snigdha Guna Of Kapha And Their
Applied Aspect With Clinical Assessment Of “Hingwadi Churna & Shunthyadi Kwath” In
Amavata. is undertaken with Aim and Objectives

1. To study the Guru & Snigdha Guna of Kapha conceptually.

2. To evaluate the applied aspect of Guru & Snigdha Guna of Kapha in Amavata.

3. To assess the clinical efficacy of ‘Hingwadi churna’&‘Shunthyadi kwath’ in Amavata and


patient will be recruited fulfilling the inclusion criteria duration of the trial is 45 days follow up
will be taken at the interval of 15 days and patient will be assessed on the basis of
subjective and objective parameter. after collecting the data of the study or trial it will be
analysed demographically and statistically with suitable method.

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