A CLINICAL TRIAL TO STUDY THE EFFECT OF A MULTIPAL DRUG FORMULATION, SHALLAKIADI YOGA IN AMAVATA (RHEUMATOID ARTHRITIS)

Phase 2/3

Not yet recruiting

• Conditions: Other rheumatoid arthritis with rheumatoid factor. Ayurveda Condition: AMAVATA,

• Registration Number: CTRI/2022/07/044321
• Lead Sponsor: SDM COLLEGE OF AYURVEDA AND HOSPITAL

Brief Summary

Amavata is a disease caused due to accumulatedama and vitiated vata dosha leading to shoola, shotha and stabdhata in thesandhis. The features of Amavata are similar to Rheumatoid Arthritis, anautoimmune disorder which causes chronic inflammation and symmetric, peripheralpolyarthritis. Rheumatoid Arthritis is one of the leading causes of YLD (Yearslived with Disability) at global levels. Theshamana chikitsa is expected to provide adequate results for this chronicdisease. Shallakiadi Yoga contain ingredients which are locally available, easyto prepare and possess deepana, amapachaka, sothahara and shoolaharaproperties. The ingredients of both formulations have gunas antagonist to ama,which are very much required in the management of Amavata. Shallakiyaadi yoga 3 tablets thrice a day will be given after food. This medicine will be given for 15 days. With a view that the selected the aims to evaluate the combinedeffectiveness of Shallakiadi Yoga in Amavata.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-07-21
• Study Start: 2022-07-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Amavata with features of Rheumatoid Arthritis as specified in 2010 ACR-EULAR classification criteria for Rheumatoid Arthritis with less than 5 years of chronicity (Parameters in ACR-EULAR criteria: Duration of symptoms, joint distribution, serology, acute phase reactants) 2.
• Subjects aged between 18 -75 years 3.
• Subjects of either gender 4.
• Subjects willing to participate in the study and ready to sign informed consent form.

Exclusion Criteria

• Subjects with known case of uncontrolled hypertension, diabetes mellitus, renal, hepatic and cardiac function 2.
• Subjects with known case of Systemic arthritis (gout, tubercular arthritis, systemic lupus erythematosus, psoriatic arthritis) 3.
• Pregnant and lactating women 4.
• Subjects used/using Steroids more than 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
– Lakshanas of Amavata- angamarda, aruchi, trishna, alasya, gaurava, jwara, apaka, shotha, shoola, stabdhata of sandhi.	15 days

Secondary Outcome Measures

Name	Time	Method
– ACR EULAR score, DAS – 28 score[18],RAPID 3 score, grip strength, foot pressure.	15 days

Trial Locations

Locations (1)

SDM COLLEGE OF AYURVEDA AND HOSPITAL HASSAN; 🇮🇳 Hassan, KARNATAKA, India

SDM COLLEGE OF AYURVEDA AND HOSPITAL HASSAN

🇮🇳Hassan, KARNATAKA, India

DR GIRISH KJ

Principal investigator

9448646855

girideepa@yahoo.co.in