A Randomized, Double Blind, Placebo Controlled, ComparativeStudy to Evaluate the Efficacy and Safety of “Herbal Extract(Bonfend Tablets)†to prevent Steroid Induced OsteoporoticChanges in Patients with Rheumatoid Arthritis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in lumbar spine BMD compared between Herbal
研究概览
简要总结
Osteoporosis and its main complication, fragility fractures, incur substantial global morbidity andmortality. Glucocorticoids are important therapeutic agents that have been used for their potent antiinflammatory and immunosuppressive properties for over 50 years in patients of RA. Pharmanza Herbal has developed an Ayurvedic Proprietary Medicine. Hence, to test this hypothesis,a study titled “A Randomized, Double Blind, Placebo Controlled, Comparative Study to Evaluate theEfficacy and Safety of “Herbal Extract (Bonfend Tablets)†to prevent Steroid Induced OsteoporoticChanges in Patients with Rheumatoid Arthritis†is planned.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Willing and able to provide written informed consent and comply with the requirements of the study protocol.
- •Adult subjects of either gender in age group of 18 – 65 years.
- •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.
- •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.
- •No history of addiction to any recreational drug or drug dependence.
排除标准
- •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.
- •Major surgical procedure within 28 days prior to randomization.
- •4.Difficulty in swallowing and retaining oral formulation.
- •Any condition that in opinion of the Investigator, does not justify the subjects’ 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
- •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 RA
- •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).
- •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.
- •23.History of significant cytopenia’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.
- •AST or ALT > 2.5 times upper limit of normal (UNL) c.
- •Neutrophil < 1.5 x 103/μL.
结局指标
主要结局
Change in lumbar spine BMD compared between Herbal
时间窗: 2 months
Tablet and Placebo from baseline at the end of 2 months.
时间窗: 2 months
Change in DAS 28-ESR compared between Herbal Tablet and
时间窗: 2 months
Placebo from baseline at the end of 2 months (Appendix C).
时间窗: 2 months
Change in Bone Specific Alkaline Phosphate (BSAP), P1NP
时间窗: 2 months
(Procollagen Type 1 N-Terminal Propeptide), Rheumatoid
时间窗: 2 months
Factor and C-reactive protein (CRP) compared between
时间窗: 2 months
Herbal Tablet and Placebo from baseline at the end of 2
时间窗: 2 months
months.
时间窗: 2 months
次要结局
- Change in tenderness compared between Herbal Tablet and(Placebo using VAS score from baseline at the end of 2 months.)