Health Condition 1: M818- Other osteoporosis without currentpathological fracture
Conditions
Interventions
Intervention1: Bonfend Tablets: Take tablet twice a day orally with water for 60 days with steroid dosage recommended by Physician.
Control Intervention1: Placebo tablets: Take tablet twice a day oral
Sponsors
Pharmanza herbal Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Willing and able to provide written informed consent and comply with the requirements of the study protocol. 2. Adult subjects of either gender in age group of 18 â?? 65 years. 3. History of rheumatoid arthritis, as defined by American College of Rheumatology (ACR) Classification 1for at least 3-6 months and who are about to be started on steroids for the first time. 4. If female and of childbearing potential, she shall have a negative pregnancy test at the time of screening and agrees to use adequate contraception throughout the study period. 5. No history of addiction to any recreational drug or drug dependence.
Exclusion criteria
Exclusion criteria: 1.Hypersensitivity to any of the components of Herbal Tablet or the excipients of the formulation. 2.Current treatment with NSAID, DMARD (the investigator for his opinion) or any tumor necrosis factor (TNF) inhibitors or other anti-arthritic therapy within 2 weeks prior to randomization. 3. Major surgical procedure within 28 days prior to randomization. 4.Difficulty in swallowing and retaining oral formulation. 5. Any condition that in opinion of the Investigator, does not justify the subjectsâ?? participation in the study. 6.Patients with significant systemic manifestation of RA. 7.Female nursing patients. 8.Rheumatic autoimmune disease other than RA. 9.History of diagnosis of juvenile idiopathic arthritis (JIA) (also known as juvenile rheumatoid arthritis [JRA]) and/or RA before age 16. 10.History of inflammatory arthritis other than RA (e.g. Inflammatory bowel disease (IBD), systemic lupus erythematosus (SLE) or psoriatic arthritis). 11.Functional Class IV as defined by the American College of Rheumatology (ACR) classification of functional status in RA2. 12.Use of intra-articular or parenteral corticosteroids within 4 weeks prior to screening visit. Inhaled corticosteroids for stable medical conditions are allowed. 13.Receipt of vaccine within 4 weeks prior to enrollment visit. 14.History of primary or secondary immunodeficiency. Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, renal, hepatic, endocrine, gastrointestinal, or pulmonary disease, including any pulmonary or other condition that would preclude subject participation. 15.Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease but excluding fungal infections of nail beds). 16.History of travel to areas endemic for mycoses, such as histoplasmosis, coccidioidomycosis or blastomycosis 17.History of recurrent significant infection or any significant episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening oral antibiotics within 2 weeks prior to screening 18.History of cancer, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinoma of the skin that have been excised and cured). 19. Lack of peripheral venous access. 20.History of chronic daily use of narcotic analgesics. 21.History of alcohol, drug, or chemical abuse within 6 months prior to screening. 22.Positive history of Hepatitis B surface antigen or antibodies to Hepatitis C. 23.History of significant cytopeniaâ??s or other bone marrow disorder. 24.Laboratory exclusion criteria: Patients may not participate in this study until any of the following that are present have resolved. a. Serum creatinine > 1.4 mg/dL for women or 1.6 mg/dL for men. b. AST or ALT > 2.5 times upper limit of normal (UNL) c. Neutrophil
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in lumbar spine BMD compared between Herbal Tablet and Placebo from baseline at the end of 2 months. Change in DAS 28-ESR compared between Herbal Tablet and Placebo from baseline at the end of 2 months (Appendix C). Change in Bone Specific Alkaline Phosphate (BSAP), P1NP (Procollagen Type 1 N-Terminal Propeptide), Rheumatoid Factor and C-reactive protein (CRP) compared between Herbal Tablet and Placebo from baseline at the end of 2 months.Timepoint: 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in tenderness compared between Herbal Tablet and Placebo using VAS score from baseline at the end of 2 months. (Appendix D). Change in swollen joint counts compared between Herbal Tablet and Placebo using VAS score from baseline at the end of 2 months (Appendix D). Change in pain scale compared between Herbal Tablet and Placebo using VAS score from baseline at the end of 2 months (Appendix D). Treatment emergent AE or SAE Timepoint: 2 months | — |
Countries
India
Contacts
Public ContactMr Nimesh Parekh
COD Research Pvt Ltd
Outcome results
None listed