A MULTIARM STUDY TO ASSESS THE EFFECT OF VIRECHAN KARMA IN RHEUMATOID ARTHRITIS IN RELATION TO AMAVATA

A MULTIARM STUDY TO ASSESS THE EFFECT OF VIRECHAN KARMA ALONGWITH STANDARD TREATMENT IN THE MANAGEMENT OF SEROPOSITIVE RHEUMATOID ARTHRITIS IN RELATION TO AMAVATA - RA

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039706

Enrollment

Registered

2022-01-25

Start date

Unknown

Completion date

Unknown

Last updated

2022-10-17

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

Conditions

Health Condition 1: M05-M14- Inflammatory polyarthropathies

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1 Patients of age group between 18 to 60 years 2 Patients who are ready to give written informed consent 3 Patients should fulfil the 2010 ACR (American College of Rheumatology) EULAR (European League Against Rheumatism Criteria) criteria for rheumatoid arthritis 4 Chronicity of disease of at least 6 months and not more than 5 years 5 Having atleast 4 symptoms out of these 9 classical symptoms: sandhisotha (swelling in multiple joints), sandhiruja (polyarthalrgia), gatrasatabdta (stiffness in body parts), angamarda (bodyache), jwara (fever), aruchi (anorexia), aalasya (laziness), utsaha-hani (lack of enthusiasm), gauravam (heaviness)

Exclusion criteria

Exclusion criteria: 1 Patients who are contraindicated for virechan karma such as muktanal(incontinence of stool), gudabhransha(rectal prolapse),adhoga raktapitta (lower GI bleeding) 2 Chronicity of disease is less than 6 months and more than 5 years 3 Patients having severe crippling bone deformities, subcutaneous nodules and severely damaged joint and bed ridden patients 4 Patients diagnosed with malignancy of any system and having active tuberculosis. 5 Patients who are immune-compromised 6 Patients who are diabetic having HbA1c more than 7.5% 7 Pregnant women and lactating mother 8 Any patient with CRF, fatty liver stage 3 and chronic illness of other body organs 9 Those with Cholecystectomy

Design outcomes

Primary

Measure	Time frame
1 The assessment of effect of virechana karma on the cardinal features and RA specific biomarkers 2 The assessment of effect of virechana karma along with shamana medicine 3 The assessment of effect of virechana karma along with RA standard medication Timepoint: Gp A- classical features of amavata,SDAI scale, RA factor, Anti-CCP, ESR, CRP [Time Frame: 31st day] Gp B- classical features of amavata, SDAI scale,RA factor, Anti-CCP, ESR, CRP [Time Frame: 53rd day] Gp C- classical features of amavata, SDAI scale,RA factor, Anti-CCP, ESR, CRP [Time Frame: 53rd day] In Gp A- CRP, SDAI scale [Time frame: 16th day] In Gp B and Gp C-CRP, SDAI scale [Time frame: 22nd day and on 37th day]	—

Measure

Time frame

1 The assessment of effect of virechana karma on the cardinal features and RA specific biomarkers 2 The assessment of effect of virechana karma along with shamana medicine 3 The assessment of effect of virechana karma along with RA standard medication Timepoint: Gp A- classical features of amavata,SDAI scale, RA factor, Anti-CCP, ESR, CRP [Time Frame: 31st day] Gp B- classical features of amavata, SDAI scale,RA factor, Anti-CCP, ESR, CRP [Time Frame: 53rd day] Gp C- classical features of amavata, SDAI scale,RA factor, Anti-CCP, ESR, CRP [Time Frame: 53rd day] In Gp A- CRP, SDAI scale [Time frame: 16th day] In Gp B and Gp C-CRP, SDAI scale [Time frame: 22nd day and on 37th day]

—

Secondary

Measure	Time frame
1.The safety profile of virechana karma and shamana medicine in seropositive RA. 2.Assessment of effect of shamana medicine on biomarkers of Rheumatoid arthritisTimepoint: LFT, KFT, CBC, Urine routine and microscopic [time frame: gp A- 31st day and in Gp B and C- 53rd day]	—

Countries

India

Contacts

Public ContactDr Bhawna Bhardwaj

Ayurvedic and Unani Tibbia College and Hospital

nitjin2005@gmail.com9354925045

Outcome results