Clinical study on Rheumatoid arthritis -AMRA 2.0

A double blind, double dummy, randomized controlled study to evaluate the efficacy of Classical Ayurveda management versus Methotrexate in Rheumatoid Arthritis (AMRA 2.0 ) - AMRA 2.0

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/07/113624

Enrollment

140

Registered

2026-07-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: M069- Rheumatoid arthritis, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adults of any gender, aged between 18 and 75 years, meeting 2010 ACR or EULAR criteria for Rheumatoid Arthritis 2.Anti-CCP or RF positive; if both are negative, a radiograph of hands, wrists and feet (PA and oblique) , clinically conclusive for erosions typical of RA. 3.Individuals who are clinically stable for 4 weeks or greater and able to comply to study interventions for 9 months. 4.Individuals who are clinically stable for 4 weeks or greater and able to comply to study interventions for 9 months. 5.History of symptoms of RA for less than 15 years and not wheelchair bound 6.Active disease as defined by DAS28 CRP scores greater than or equal to 3.2

Exclusion criteria

Exclusion criteria: 1.History of usage of classical Ayurveda treatment or OTC products for RA for greater than 4 week. 2.Currently enrolled in another clinical trial OR received an investigational drug OR has within 3 months (or 5 half-lives, whichever is longer) prior to entry in the study.

Design outcomes

Primary

Measure	Time frame
Change in DAS 28 (CRP)Timepoint: Baseline, Day 90, Day 180, Day 270	—

Secondary

Measure	Time frame
Proportion of participants achieving an ACR20/50/70 response, Proportion of participants on disease remission as assessed by DAS 28 score of less than 2.6, Proportion of Participants on with DAS 28 low disease activity (score less than 3.2), Change in inflammatory response assessed by CRP, IL-6,IL-1, IL-17,TNF-alpha, Change in disease associated functional disability assessed by Health Assessment Questionnaire Disability Index (HAQ-DI), Assessment of changes over time in clinical laboratory parameters of safetyTimepoint: Baseline, Day 90, Day 180, Day 270;Change in Quality of Life (QoL) assessed using SF-36 Health Survey, Proportion of participants with Adverse Events, and Serious Adverse Events categorized as per severityTimepoint: Baseline to Day 270	—

Measure

Time frame

Proportion of participants achieving an ACR20/50/70 response, Proportion of participants on disease remission as assessed by DAS 28 score of less than 2.6, Proportion of Participants on with DAS 28 low disease activity (score less than 3.2), Change in inflammatory response assessed by CRP, IL-6,IL-1, IL-17,TNF-alpha, Change in disease associated functional disability assessed by Health Assessment Questionnaire Disability Index (HAQ-DI), Assessment of changes over time in clinical laboratory parameters of safetyTimepoint: Baseline, Day 90, Day 180, Day 270;Change in Quality of Life (QoL) assessed using SF-36 Health Survey, Proportion of participants with Adverse Events, and Serious Adverse Events categorized as per severityTimepoint: Baseline to Day 270

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Countries

India

Contacts

Public ContactDr Shubhashree M N

Central Ayurveda Research Institute

drshubhathejas@gmail.com9448016968

Outcome results