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

A COMPARATIVE STUDY OF SHOOLHARA KASHAYA AND KAKAMACHYADI LEPA WITH IBUPROFEN TABLET AND DICLOFENAC GEL IN AMAVATA WITH SPECIAL REFERENCE TO RHEUMATOID ARHTRITIS AN OPEN LABEL RANDOMIZED CONTROLLED CLINICAL TRIAL - CSSKKLIDARA

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031540
Enrollment
60
Registered
2021-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

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

Interventions

Intervention1: DEEPAN YOGA SHOOLHARA KASHAYA KAKAMACHYADI LEPA: DEEPAN YOGA 3 gm bid after food with lukewarm water SHOOLHARA KASHAYA 30ml bid empty stomach with anupaan Saindhav lavan or Sita or Ma

Sponsors

All India Institute of Ayurveda
Lead Sponsor

Eligibility

Inclusion criteria

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 â?ª >6 weeks 1 4) Patients willing to participate in the research study

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
1)Reduction in VAS Score. 2)Providing the Vednahara (analgesic) effect management of Amavata (RA) with Ayurvedic shaman chikitsa.Timepoint: 55 Days

Secondary

MeasureTime frame
Improvement in the quality of life with the help of questionnaires for scaling of W.H.O quality of life.Timepoint: 55 Days

Countries

India

Contacts

Public ContactRama Kant Yadava

All India Institute of Ayurveda

archanashukla9643@gmail.com9643746101

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026