| CTRI Number |
CTRI/2023/07/055293 [Registered on: 17/07/2023] Trial Registered Prospectively |
| Last Modified On: |
30/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study the effect of Pavanari Rasa for pain management in Amavata. |
|
Scientific Title of Study
|
Clinical study of Pavanari Rasa on pain in patients of Amavata with special reference to Rheumatoid arthritis - a randomised controlled trial . |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tapaswini Dalasinghray |
| Designation |
PG Scholar |
| Affiliation |
National Institute Of Ayurveda, Jaipur,Rajasthan |
| Address |
National Institute Of Ayurveda, Jaipur, Near Jorwar singh gate, Amer Road, Rajasthan, 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
7008756788 |
| Fax |
|
| Email |
tapaswinidalasinghray@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar Sahu |
| Designation |
Consultant |
| Affiliation |
National Institute Of Ayurveda, Jaipur,Rajasthan |
| Address |
Department of Kayachikitsa , National Institute of Ayurveda, Deemed To Be University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan – 302002
,India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9950708106 |
| Fax |
|
| Email |
drajaysahu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ajay Kumar Sahu |
| Designation |
Consultant |
| Affiliation |
National Institute Of Ayurveda, Jaipur,Rajasthan |
| Address |
Department of Kayachikitsa , National Institute of Ayurveda, Deemed To Be University (De-Novo) Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan – 302002
,India
Jaipur
RAJASTHAN
302002
India |
| Phone |
9950708106 |
| Fax |
|
| Email |
drajaysahu@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda , Jaipur,Deemed to be university,Near jorawar singh gate gate, Amer road ,Jaipur. |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda |
| Address |
National Institute of Ayurveda, Deemed To Be University (De-Novo), Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan – 302002 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrTapaswini Dalasinghray |
Hospital, National Institute of Ayurveda Deemed to be University Jaipur |
OPD NO.1,18,22,25, and IPD of Hospital,National Institute of Ayurveda, Deemed to be Univ ersity, Near Jorawor Singh gate, Amer Road, Jaipur, Rajasthan 302002 Jaipur Rajasthan
Jaipur
RAJASTHAN |
7008756788
tapaswinidalasinghray@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of National Institute of Ayurveda, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:M04-M04||Autoinflammatory syndromes. Ayurveda Condition: AMAVATAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Pavanari Rasa, Reference: Abhinav Chintamani vol.2, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 250(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Etoricoxib | Medicine name- Etoricoxib,Route- Oral,Dose-60mg,
Dosage form-Tablet,Frequency-O.D,
Time of administration- Evening (with water),Duration-14days. |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 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 25 to 60 years, irrespective of sex and socio-economic status.
3. Patients having signs and symptoms of ‘Amavata’ (Rheumatoid Arthritis)
4. Patients fulfill the criteria of ACR / EULAR 2010 criteria (American College of Rheumatology /European League Against Rheumatism)
5. Patients with chronicity of less than 5 years.
|
|
| ExclusionCriteria |
| Details |
1. Patients having severe joint deformities.
2. Patients having age < 20 years & > 60 years .
3. Patients suffering from paralysis.
4. Patients having any type of arthropathy such as Neoplasm of spine, Gout, Ankylosing spondylosis, Traumatic arthritis and Pyogenic osteomyelitis etc.
5. Patients having associated Cardiac disease, Tuberculosis, Diabetes mellitus, Malignant Hypertension, Renal Function Impairment, Hypothyroidism, Rheumatic Heart Disease etc.
6. Patients with extremely reduced joint space.
7. Pregnant women and lactating mother.
8. Patient taking disease modifying anti-rheumatic drugs (DMARDs) for rheumatoid arthritis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changes in Pain score. |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in symptoms of Amavata, Improvement in quality of life and changes in DAS-28 score, CRP, RA Factor, Disability Index Score, other symptoms, Improvement in walking time,hand &foot grip. |
30 days |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2023 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Participants attending the OPD and IPD of the NIA hospital and satisfying the selection criteria will be selected. All the participants who voluntarily agree to participate and provide informed written consent for participation will be recruited in the study. Total 40 participants will be selected after details examination and divided in 2 group of 20 patients each as per study protocol. All Procedures will be executed under aseptic condition . The changes observed in the sign and symptoms will be assessed by adopting suitable scoring method and the objective signs by using appropriate clinical tools- Baseline and weekly . DAS-28 score & ESR will be assessed on the Baseline and 15th day of the study .
|