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

All India Institute of Ayurveda0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

•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

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