Clinical Evaluation of Simhanaada Guggulu and Brihata Saindhavadi Taila in the Management of Rheumatoid Arthritis.
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 3
- Primary Endpoint
- • Changes in DAS-28 score
Study Overview
Brief Summary
Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia Committee (APC) during August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country.
Simhanaada Guggulu isa polyherbal Ayurvedic formulation containing Haritaki (Terminalia chebula), Bibhitaka (Terminalia belerica), Amlaki (Emblica officinalis), Gandhaka (Sulphur), Guggulu (Commiphora wightii) and Eranda (Ricinus communis).
Brihata Saindhavadi Taila is a medicated classical Ayurvedic oil preparation contain Saindhava lavana (Rock salt), Gajapippali (Scindapsus officinalis), Rasana (Alpinia galanga), Satpuspa (Anethum sowa), Yavani (Trachyspermum ammi), Svarjiksara (Crude alkaline earth), Marica (Piper nigrum), Kustha (Saussurea lappa), Sunthi (Zingiber officinale), Saurvancala Lavana (Black salt), Vida Lavana, Vaca (Acorus calamus), Ajmoda (Apium leptophyllum), Yashtimadhu (Glycyrrhiza glabra), Sveta Jiraka (Cuminum cyminum), Puskara (Inula racemosa), Pippali (Piper longum), Eranda Taila (Ricinus communis), Satapuspajambu (Anethum sowa), Kanjika (Sour gruel) and Mastu (Curd whey from cow milk).
The present study is being undertaken in three post graduate Ayurveda colleges involving the post graduate scholars who are doing the clinical trials to scientifically study and validate the clinical efficacy and safety of Simhanaada Guggulu and Brihata Saindhavadi Taila- classical Ayurvedic formulation which have been in use since ages and found to be useful in treating Rheumatoid Arthritis and promoting the health.
The Central Council for Research in Ayurvedic Sciences (CCRAS) is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the project.
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 20.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either sex with age between 20 and 60 years 2) Presence of any four out of the following seven criteria (according to 1987, revised criteria of American College of Rheumatology) a.
- •Morning stiffness: Stiffness in and around joints lasting one hour before maximal improvement (More than 6 week’s duration).
- •Arthritis of three or more joints, at least three joint area, observed by Physician, having pain with soft tissue swelling or joint effusion, not just bony over growth, (more than 6 weeks duration).
- •Arthritis of hand joints, at least 1 area in wrist and hand is swollen (more than 6 weeks duration).
- •Symmetric arthritis (more than 6 week’s duration).
- •Presence of rheumatoid Nodules f.
- •Serum rheumatoid factor- positive g.
- •Typical radiographic changes of arthritis on PA view of hand & wrist radiograph that must include erosions or unequivocal bony decalcification, localized in or adjacent to involved joints.
- •PATIENTS Willing and able to participate in the study for 16 weeks.
Exclusion Criteria
- •Patients who have developed complications of Rheumatoid Arthritis e.g. deformity of joints / bones , pleura-pericardial disease, or else.
- •Patients who are unable to walk without support and / or confined to wheel chair.
- •Patients with structural deformity as the complication of RA.
- •Patients with poorly controlled Hypertension ( >160/100 mm of Hg)
- •Patients with Diabetes Mellitus {B.S. (F) > 126 mg% and / or B.S. (2 hr.
- •PP) >200 mg% OR HbA1c> 6.5%}
- •Patients diagnosed with other arthritis like gouty arthritis, tuberculous arthritis etc.
- •Patients on prolonged (> 6 weeks) medication with corticosteoids, antidepressants, anticholinergics, etc.
- •or any other drugs that may have an influence on the outcome of the study.
- •Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S.
- •Creatinine >1.2mg/dL), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
- •Alcoholics and/or drug abusers.
- •H/o hypersensitivity to any of the trial drugs or their ingredients.
- •Pregnant / lactating woman.
- •Patients who have completed participation in any other clinical trial during the past six (06) months.
- •Any other condition which the Principal Investigator thinks may jeopardize the study.
Outcomes
Primary Outcomes
• Changes in DAS-28 score
Time Frame: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week.
Secondary Outcomes
- • Change in Disability Index (The Indian Health Assessment Questionnaire)(• Change in acute phase reactants – ESR and CRP)