| CTRI Number |
CTRI/2020/03/024188 [Registered on: 23/03/2020] Trial Registered Prospectively |
| Last Modified On: |
07/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation of the efficacy of Ajamodadya Vataka and Rasnadashamoola Kwatha in the management of Amavata |
|
Scientific Title of Study
|
A Comparative Clinical Study to evaluate the efficacy of Ajamodadya Vataka and Rasnadashamoola Kwatha 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 |
Harshitha K S |
| Designation |
P G Scholar |
| Affiliation |
National Institute Of Ayurveda,Jaipur |
| Address |
P G Department Of Kayachikitsa, National Institute Of Ayurveda,
Amer Road,Jaipur,Rajasthan 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
7022028281 |
| Fax |
|
| Email |
harshithasathyakumar94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Ram Kishor Joshi |
| Designation |
Professor |
| Affiliation |
National Institute Of Ayurveda,Jaipur |
| Address |
P G Department of Kayachikitsa,
National Institute Of Ayurveda
Amer Road,Jaipur,Rajasthan-302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414322297 |
| Fax |
|
| Email |
joshirk1964@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Ram Kishor Joshi |
| Designation |
Professor |
| Affiliation |
National Institute Of Ayurveda,Jaipur |
| Address |
P G Department of Kayachikitsa,
National Institute Of Ayurveda
Amer Road,Jaipur,Rajasthan-302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414322297 |
| Fax |
|
| Email |
joshirk1964@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda, Jaipur-302002 |
|
|
Primary Sponsor
|
| Name |
National Institute Of Ayurveda |
| Address |
National Institute Of Ayurveda,Amer Road,Jaipur,Rajasthan 302002 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Prof Ram Kishor Joshi |
NIA Hospital |
OPD Room No 1,7,18,25 P G Department of Kayachikitsa,National Institute of Ayurveda.AMer road
Jaipur
RAJASTHAN |
9414322297
joshirk1964@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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 |
Ajamodadya vataka
Rasnadashamoola Kwatha |
Ajamodadya vataka( 1 g each) 2 tablets thrice a day orally after food- group A
Rasnadashamoola kwatha- 40 ml with 10 ml of eranda taila twice a day orally before food-Group B |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to sign consent form for the clinical trial.
2. Patients between the age group of 20 to 60 years, irrespective of sex and socio-
economic status.
3. Patients having signs and symptoms of ‘Amavata roga’ according to classical text
of Ayurveda as a subjective criteria & according to modern text books w.s.r.
Rheumatoid Arthritis as a objective criteria including Seropositive (RA Factor-
Positive) as well as Seronegative (RA Factor-Negative) both.
4. Patients with chronicity of less than 5 years.
|
|
| ExclusionCriteria |
| Details |
1. Patients having severe joint deformities.
2. Patients suffering from paralysis.
3. Patients having any type of arthropathy such as Neoplasm of spine, Gout, Ankylosing spondylosis, Traumatic arthritis and Pyogenic osteomyelitis etc .
4. Patients having associated Cardiac disease, Tuberculosis, Diabetes mellitus, Malignant Hypertension, Renal Function Impairment, Hypothyroidism, RHD etc.
5. Patients with extremely reduced joint space.
6. Pregnant women and lactating mother.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in the score of ACR,EULAR criteria |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in the laboratory parameters and the Lakshanas of Amavata like Jwara,Angamarda,Sandhishoola etc |
30 days |
|
|
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)
|
26/05/2020 |
| 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="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The
disease ‘Amavata’ is very similar to Rheumatoid Arthritis. It is chronic
in nature and effect mostly the middle age group. It is one of the common
debilitating diseases by virtue of it’s chronicity and implication. It
is mostly the disease of Madhyam Rog Marg and having Chirkari
Swabhava. Sometimes it can also be manifested as the acute case due to
their similar mode of presentation. The disease Rheumatoid Arthritis can be
broadly grouped under the heading ‘Amavata’. Here ‘Ajamodadya Vataka’, ‘Rasnasadashmoolakam
Kwatha’ along with ‘Ruksha
Sweda’ are selected for this study.Above mentioned drugs are easily
available, cost effective and easy to administer in the patients. That is the
basic reason to select these drugs for present clinical trial.40 Clinically
diagnosed and registered patients of ‘Amavata’ will be divided randomly into two groups. Each group will have 20
patients.
- Group A- 20 clinically diagnosed and
registered patients of ‘Amavata’ will be treated by ‘Ajamodadya
Vataka’ 2 Tab (each Tab 1gm) three times in a day with lukewarm
water after meals, for 30 days as Oral medication with ‘Ruksha sweda’
two times a day for 30 days
- Group B-
20 clinically diagnosed and registered patients of ‘Amavata’ will be
treated by ‘Rasnadashmoolakam Kwatha’ 40 ml added with
‘Eranda Tail’ 10ml(based on the koshta of the patient i.e, krura,mridu
and madhyama) two times in a day (morning & evening) for 30 days
before meals orally and ‘Ruksha
sweda’ two times a days for 30 days
1.Open label. 4.Interventional.
2.Randomized. 5.Prospective type.
3.Single Centre.
|