| CTRI Number |
CTRI/2019/01/017061 [Registered on: 14/01/2019] Trial Registered Prospectively |
| Last Modified On: |
29/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [TREATMENT] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF AGNILEPA (APPLICATION OF HERBAL PASTE) FOLLOWED BY VIRECHANA KARMA (PURGATION THERAPY) AND AGNILEPA FOLLOWED BY VAITARNA BASTI (MEDICATED ENEMA) IN AMAVATA WSR TO RHEUMATOID ARTHRITIS |
|
Scientific Title of Study
|
A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY OF AGNILEPA FOLLOWED BY VIRECHANA KARMA AND AGNILEPA FOLLOWED BY VAITARNA BASTI IN AMAVATA W.S.R TO RHEUMATOID ARTHRITIS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ASHA M R |
| Designation |
POST GRADUATE SCHOLAR |
| Affiliation |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
NO 10 PIPELINE ROAD RPC LAYOUT VIJAYANAGAR BENGALURU 560104
2731 3RD MAIN ROAD V V MOHALLA MYSORE 570002
Bangalore
KARNATAKA
560104
India |
| Phone |
9739525530 |
| Fax |
|
| Email |
ashamr1989@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VINAY KUMAR K N |
| Designation |
READER |
| Affiliation |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
NO 10 PIPELINE ROAD RPC LAYOUT VIJAYANAGAR BENGALURU 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9845617690 |
| Fax |
|
| Email |
knvgowda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ASHA MR |
| Designation |
Post graduate scholar |
| Affiliation |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
| Address |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
NO 10 PIPELINE ROAD RPC LAYOUT VIJAYANAGAR BENGALURU 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9739525530 |
| Fax |
|
| Email |
ashamr1989@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DR ASHA M R |
| Address |
PG SCHOLAR
DEPARTMENT OF PANCHAKARMA,
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
NO 10 PIPELINE ROAD RPC LAYOUT VIJAYANAGAR BENGALURU
|
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NOT APPLICABLE |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR VINAY KUMAR K N |
SRI KALABYRAVESHWARA SWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
NO 10 PIPELINE ROAD RPC LAYOUT VIJAYANAGAR BENGALURU
Bangalore
KARNATAKA |
9845617690
knvgowda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKAMCHRC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M04||Autoinflammatory syndromes, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AGNILEPA FOLLOWED BY VAITARANA BASTI |
AGNILEPA FOLLOWED BY VAITARANA BASTI IN AMAVATA WSR RHEUMATOID ARTHRITIS |
| Intervention |
AGNILEPA FOLLOWED BY VIRECHANA |
AGNILEPA FOLLOWED BY VIRECHANA IN AMAVATA WSR RHEUMATOID ARTHRITIS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
PATIENT AGE RANGING FROM 18 TO 70 YEARS
PATIENT WITH LAKSHANAS OF AMAVATA
PATIENT WITH RHEUMOTIOD ARTHRITIS FEATURES
PATIENT FIT FOR VIRECHANA KARMA
PATIENT FIT FOR BASTI KARMA
|
|
| ExclusionCriteria |
| Details |
ANY OTHER SYSTEMIC DISORDERS WHICH INTERFERS THE COURSE OF TREATMENT |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EFFICACY OF HERBAL PASTE APPLICATION WITH PURGATION OR WITH MEDICATED ENEMA OVER SUBJECTIVE AND OBJECTIVE CRITERIA OF AMAVATA WSR RHEUMOTOID ARTHRITIS |
BEFORE TREATMENT
5TH OF AGNI LEPA
AFTER VIRECANA |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
16/01/2019 |
| Date of Study Completion (India) |
14/11/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THE
DISEASE AMAVATA, AFFECTING THE JOINTS THE DISEASE MANIFESTS MAINLY DUE TO
VIRUDDHAHARA AND CHESHTA. THE SYMPTOMS OF AMAVATA ARE IDENTICAL TO RHEUMATOID
ARTHRITIS. RHEUMATOID ARTHRITIS AFFECTS APPROXIMATELY 1%OF THE ADULT POPULATION
HENCE THE PRESENT STUDY IS TO EVALUATETHE EFFECT OF AGNILEPA FOLLOWED BY
VIRECHANA AND AGNILEPA FOLLOWED BY VAITARANA BASTI IN AMAVATA WSR TO RHEUMATOID
ARTHRITIS |