| CTRI Number |
CTRI/2019/01/016976 [Registered on: 08/01/2019] Trial Registered Prospectively |
| Last Modified On: |
07/01/2019 |
| 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 Effect Of Dhanya Nagara Kwatha (Herbal Decoction) With Karisha Pinda Sweda (Powder Of Dry Cow Dung) And Rasonadi Kwatha (Herbal Decoction) With Karisha Pinda Sweda (Powder Of Dry Cow Dung) In The Management Of Amavata Wsr To Rheumatoid Arthritis |
|
Scientific Title of Study
|
A Comparative Clinical Study To Evaluate The Effect Of Dhanya Nagara Kwatha With Karisha Pinda Sweda And Rasonadi Kwatha With Karisha Pinda Sweda In The Management Of 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 ASHWINI A |
| Designation |
PG Scholar |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre |
| Address |
Department of Kayachikitsa
Room No 2
SKAMCH and RC No 10 Pipeline Road Vijayanagar
Bengaluru 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9480099554 |
| Fax |
|
| Email |
ashuappaji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajashekhar CV |
| Designation |
Professor |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre Bangalore |
| Address |
Department of Kayachikitsa
Room No 2
SKAMCH and RC No 10 Pipeline Road Vijayanagar
Bengaluru 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
8867212844 |
| Fax |
|
| Email |
drrajhere@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwini A |
| Designation |
PG Scholar |
| Affiliation |
SRI KALABYRAVESHWARASWAMY AYURVEDIC MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER |
| Address |
Department of Kayachikitsa
Room No 2
SKAMCH and RC No 10 Pipeline Road Vijayanagar
Bengaluru 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
09480099554 |
| Fax |
|
| Email |
ashuappaji@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ashwini A |
| Address |
No 10 Pipeline Road Vijayanagar
Bengaluru 560104 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR RAJASHEKHAR CV |
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre |
Department of Kayachikitsa
Room No 2
SKAMCH and RC No 10 Pipeline Road Vijayanagar
Bengaluru 560104
Bangalore
KARNATAKA |
8867212844
drrajhere@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A Dhanya Nagara Kwatha with Karisha Pinda Sweda |
Group a Dhanya Nagara Kwatha 24ml Twice Daily Befor Food For 14days With Karisha Pinda Sweda For 7days |
| Comparator Agent |
Group B Rasonadi Kwatha With Karisha Pinda Sweda |
Group B Rasonadi Kwatha 24ml Twice Daily Befor Food For 14days With Karisha Pinda Sweda Fro 7days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients Presenting With Lakshanas Of Amavata Will Be Selected
Patients Presenting With The Signs And Symptoms Of Rheumatoid Arthritis Will Be Selected
Patient Of Age Group 16 70 Years Madhyama Vaya Irrespective Of Sex Religion And Occupation |
|
| ExclusionCriteria |
| Details |
Patients With Other Systemic And Metabolic Disorder Such As Diabetes And Hypertension Which Interfere With The Treatment
Patients Presenting With Complications Of Rheumatoid Arthritis
All Joint Disorder Other Than Rheumatoid Arthritis |
|
|
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 The Intervention Over Subjective And Objective Criteria Of Amavata |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NOT APPLICABLE |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
10/01/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="3"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NOT YET PUBLISHED |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
AMAVATA
IS A DISEASE WHICH MANIFESTS DUE TO UNHEALTHY FOOD HABITS AND LIFESTYLE CHANGES
RESULTING IN IMBALANCE OF AGNI AND VITIATION OF DOSHAS. THE SIGNS AND SYMPTOMS
OF AMAVATA IS SIMILAR TO THE CLINICAL FEATURES OF RHEUMATOID ARTHRITIS (RA).THE
PREVALENCE OF THIS DISEAES IS
APPROXIMATELY 1% OF GLOBAL POPULATION AND AROUND 0.9% AMONG INDIANS. THE PRESENT STUDY IS DESIGNED TO EVALUATE THE
EFFECT OF DHANYA NAGARA KWATHA WITH KARISHA PINDA SWEDA AND RASONADI KWATHA
WITH KARISHA PINDA SWEDA IN AMAVATA WHICH HAS AMA PACHANA SHOOLAHARA AND
VATASHAMANA PROPERTIES. |