CTRI/2014/09/004967已完成4 期
A Double blind, Randomized, Placebo Controlled, Proof-of-concept, Comparative study to evaluate the Efficacy & Safety of ZANOSTO TABLET in patients suffering from Osteopenia
Emami Limited Kolkata0 个研究点目标入组 60 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients of either sex between the age group of 30-75 years (both years inclusive)
- •2.Patients suffering from Osteopenia with BMD T- score between (-1 to -2.5)
- •3.Those with a history of fractures that may have occurred with a minor injury or fall
- •4.Ready to abide by trial procedures and to give informed consent
排除标准
- •1.Patients consuming any drug known to affect bone metabolism for e.g. SERMs, bisphosphonates, calcitonin, Vit.D (more than 60,000 units) and corticosteroids (more than 5mg/day of prednisolone or equivalent) for more than 3 months, methotrexate, anti- convulsants, diuretics, etc.
- •2.Patients whose Serum Ca++ level is either < 2.2 or > 2.6 mmol/L ( < 9 or >10.5 mg/dL)
- •3.Patient suffering from Osteomalacia, Tumor, Osteonecrosis, infection, and other bone-softening metabolic disorders.
- •4.Patients suffering from congenital disorders (Dysosteogenesis and Marfanâ??s Syndrome)
- •5.Patients with Leukemia, Lymphoma, Metastases (bony and other), Pathologic fractures secondary to bone metastases from cancer, Pediatric osteogenesis imperfect or Renal osteodystrophy, Malabsorption syndrome
- •6.Patients with endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushingâ??s syndrome)
- •7.Patients who have undergone Organ transplantation
- •8.Patients who are immobilized since > 6 weeks
- •9.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •10.Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg)
- •11.Any other serious illness e.g. Hepatic/renal failure.
- •12.Patient receiving any other treatment for osteopenia other than vitamin supplements.
- •13.Patients requiring long term treatment of oral and/or injectable steroids or surgical intervention.
- •14.Symptomatic patient with clinical evidence of Heart failure.
- •15.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease.
- •16.Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
- •17.Alcoholics and/or drug abusers.
- •18.Pregnant and lactating women,
- •19.H/o hypersensitivity to any of the trial drugs or their ingredients
- •20.Patients who have completed participation in any other clinical trial during the past six (06) months.
- •21.Any other condition which the P.I. thinks may jeopardize the study
研究者
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