A ROLE OF SHOOLHARA KASHAYA AND KAKAMACHYADI LEPA TREATMENT IN AMAVATA (RHEUMATOID ARHTRITIS)

Phase 4

• Conditions: Health Condition 1: M057- Rheumatoid arthritis with rheumatoid factor without organ or systems involvement

• Registration Number: CTRI/2021/02/031540
• Lead Sponsor: All India Institute of Ayurveda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1)Patients having the clinical manifestation of Amavata (RA) according to Ayurvedic

classics - SANDHISHOOL (PAIN), SHOTH (SWELLING), SPARSHASAHTA (TENDERNESS) and STABDHATA (STIFFNESS),Vrishichikadansavata vedana

(pain like scorpion sting), Agnimandya (poor digestion) , Aruchi(anorexia), Gaurav(Feeling

of heaviness of body),Utsaha Hani(lack of interest),Mukha vairasya(Perverted taste) or

having positive RA factor.

2)The 2010 American College of Rheumatology/ European League Against Rheumatism

classification criteria for rheumatoid arthritis Score.

3)Classification criteria for RA (score-based algorithm: add score of categories Aâ??D; a score of 6/10 is needed for classification of a patient as having definite RA).

A. Joint involvement

â?ª 1 large joint 0

â?ª 2-10 large joints 1

â?ª 1-3 small joints (with or without involvement of large joints) 2

â?ª 4-10 small joints (with or without involvement of large joints) 3

â?ª >10 joints (at least 1 small joints) 5

B. Serology (at least 1 test result is needed for classification)

â?ª Negative RF and negative ACPA 0

â?ª Low-positive RF or low-positive ACPA 2

â?ª High-positive RF or high-positive ACPA 3

C. Acute-phase reactants (at least 1 test result is needed for classification)

â?ª Normal CRP and normal ESR 0

â?ª Abnormal CRP or abnormal ESR 1

D. Duration of symptoms

â?ª <6 weeks 0

â?ª >6 weeks 1

4) Patients willing to participate in the research study

Exclusion Criteria

1) Patients with other systemic complications of RA like RHD, Rheumatic fever, pleural â??

pericardial disease.

2) Patients with poorly controlled Hypertension ( >160/100 mm of Hg)

3) Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr. PP) >200 mg%

OR HbA1c > 6.5%}

4) Patients diagnosed with other arthritis like gouty arthritis, tuberculous arthritis, etc.

5) Patients who are unable to walk without support and / or confined to wheel chair.

6) H/o hypersensitivity to any of the trial drugs or their ingredients.

7) Patients on prolonged ( > 6 weeks) medication with antidepressants, anticholinergic, etc. or

any other drugs that may have an influence on the outcome of the study.

8) Pregnant / lactating woman.

9) Patients who have completed participation in any other clinical trial during the past 6

months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1)Reduction in VAS Score. <br/ ><br>2)Providing the Vednahara (analgesic) effect management of Amavata (RA) with Ayurvedic shaman chikitsa.Timepoint: 55 Days

Secondary Outcome Measures

Name	Time	Method
Improvement in the quality of life with the help of questionnaires for scaling of W.H.O quality <br/ ><br>of life.Timepoint: 55 Days