Clinical higher investigation of Rheumatoid Arthritis patients receiving Ayurvedic therapy.

Not yet recruiting

• Conditions: Rheumatoid arthritis with rheumatoid factor without organ or systems involvement. Ayurveda Condition: AMAVATAH, (2) ICD-10 Condition: M057||Rheumatoid arthritis with rheumatoid factor without organ or systems involvement. Ayurveda Condition: AMAVATAH,

• Registration Number: CTRI/2022/07/044348
• Lead Sponsor: State Ayurvedic College and Hospital Lucknow

Brief Summary

Rheumatoid Arthritis (RA) is an autoimmune musculoskeletal disorder having a high prevalence and debility potential. Its treatment conventionally aims at early diagnosis followed by symptom management, deformity and joint destruction prevention, restoration of joint mobility and quality of life improvement. ’Clinical Metabolomic’ in RA is one step head of conventional assessment done through clinical observations generic biomarkers like ESR & CRP. Purpose of this study is to find if there are any meaningful differences among ’RA related disease activity specific metabolites’ in sample population of RA receiving ayurvedic whole system intervention considering its own method of diagnosis & treatment selection. Intervention will be given for 3 months. A 2 weekly follow-up will be done for the purpose of clinical records. Metabolomics will be performed only pre and post i.e., at the time of registration & after completion of trial. A patient population of 30 RA considering the single group & pragmatic nature of the study having a simultaneous diagnosis of Amavata and receiving specific ayurvedic comprehensive interventions (whole system approach) for 3 months will be evaluated clinically on the basis of DAS-28 score changes and will be categorized for level of improvements as ACR20, ACR50 or ACR70. This clinical outcome assessment will be supplemented by quantitative evaluation of inflammatory markers like ESR/CRP.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-08
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

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

Inclusion Criteria

Patients not in remission state as per DAS-28 ESR criteria.

Exclusion Criteria

Having co-morbid conditions like Osteoarthritis, Gout etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical metabolomic assessment and clinical outcome among the people registered under the study following the Ayurvedic whole system intervention will be done through DAS-28 ESR scoring. Final assessment will be done with the help of ACR20, ACR50 and ACR70 criteria. This clinical outcome assessment will be supplemented by quantitative evaluation of inflammatory markers like ESR/CRP.	12 weeks

Secondary Outcome Measures

Name	Time	Method
Quality of life improvement.	12 weeks

Trial Locations

Locations (1)

State Ayurvedic College and Hospital, Lucknow; 🇮🇳 Lucknow, UTTAR PRADESH, India

State Ayurvedic College and Hospital, Lucknow

🇮🇳Lucknow, UTTAR PRADESH, India

Ankita Verma

Principal investigator

8052772926

ankitavermadr@gmail.com