A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFICACY of two formulations IN THE MANAGEMENT OF AMAVATA WITH SPECIAL REFERENCE TO RHEUMATOID ARTHRITIS

Phase 2/3

Not yet recruiting

• Conditions: Autoinflammatory syndrome, unspecified. Ayurveda Condition: AMAVATAH, (2) ICD-10 Condition: M049||Autoinflammatory syndrome, unspecified. Ayurveda Condition: AMAVATAH, (3) ICD-10 Condition: M368||Systemic disorders of connective tissue in other diseases classified elsewhere,

• Registration Number: CTRI/2022/10/046235
• Lead Sponsor: Dr Seeta MBiradar

Brief Summary

Amavata is a Pain predominant joint disorder which if not managed in time may prove crippling to the life of the patient, which has been causing immense suffering to the people throughout the world. Prevalance rate in India 0.75%.The ingredients of Shoolaprashamana capsule are anti-arthritic ,analgesic ,anti-inflammatory and muscle relaxants and specify aggravated vata dosha.The ingredients of Hingutrigunataila cap are Hingu,Saindhava,Eranda taila and Rasona.However using combination of drugs can be a novel approach in the treatment of Rheumatoid Arthritis.Moreover capsule is having easy palatability and is patient friendly .To get better idea about its efficacy and clinical spectrum a Comparative CLINICAL SYUDY is taken to see the efficacy of Shoolaprashamana capsule and Hingutriguna taila capsule.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-10
• Last Update Posted: 2023-07-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

PATIENTS diagnosed as having Amavata on the basis of signs and symptoms that are typically diagnosed as classical symptoms and Rheumatoid Arthritis on basis of ACR CRITERIA FOR DIAGNOSING RHEUMATOID ARTHRITIS.

Exclusion Criteria

patients suffering from complications of Aamavata Juveline RA Septic arthritis Rheumatic Heart Disease RA with involvement of other organs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assesment will be done on Pain Swelling Morning stiffness Tenderness Fever ESR score C-RP score DAS 28 score Disability Index Quality of Life Index SF36 by adapting standard methods of scoring.	OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Angamarda	OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Aruchi	OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Alasya	OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Objective parameters	OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
C-RP	OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Anti-CCP	OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Sparshasahatva	OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Stabdata	OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Subjective parameters	OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Sandhi shoola	OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
Sandhi shotha	OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
ESR	OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days
RA factor	OBJECTIVE PARAMETERS | C-RP | ESR | RA factor | Anti-CCP | ASSESSMENT CRITERIA | Assessment will be made for clinical signs and symptoms & investigations Statistical analysis | package of version 20 will be done by using chi-square/Fisher’s test for subjective | parameters & students t test for objective parameters. | SAMPLE SIZE 120PATIENTS | 60 Patients in each group and treatment for 1month with follow up of 15days

Secondary Outcome Measures

Name	Time	Method
Incidence of Amavata as per Age Sex Lifestyle will be made in Parul Institute of Ayurveda,Parul University Vadodara,Gujarat	6months

Trial Locations

Locations (1)

BLDEAs AVS Ayurveda Hospital and Research centre,Vijayapur; 🇮🇳 Bijapur, KARNATAKA, India

BLDEAs AVS Ayurveda Hospital and Research centre,Vijayapur

🇮🇳Bijapur, KARNATAKA, India

Dr Seeta MBiradar

Principal investigator

8951695201

drseetabijapur@gmail.com