CTRI/2015/01/005474尚未招募3 期
CLINICAL EVALUATION OF ABHADYA CHURNA AND MUKTASUKTI BHASMA IN THE MANAGEMENT OFOSTEOPENIA/OSTEOPOROSIS (ASTHI KSHAYA)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 65
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
- •1Patients of either sex between 40 to 65 years of age.
- •2B.M.D -T. Score between ( -1 to -3 ) on DEXA Scan.
- •3Willing and able to participate for 14 weeks.
排除标准
- •Exclusion Criteria
- •1.Patients who are consuming corticosteroids (more than 5mg/day of prednisolone or equivalent) for more than 3 months
- •2.Patients with history of Fragility Fracture.
- •3.Patients suffering from congenital disorders related to bone (Dysosteogenesis, Marfanâ??s Syndrome, etc.)
- •4.Patients with (Hypothyroidism and Hyperthyroidism, Hypoparathyroidism and Hyperparathyroidism, Cushingâ??s syndrome)
- •5.Patients with unstable CV diseases
- •6.Patients suffering from Osteomalacia.
- •7.Patients suffering from Malabsorption syndrome
- •8. Patients who have undergone Organ transplantation
- •9.Patients who are immobilized since > 6 weeks
- •10.Patients with history of bone fracture in last 6 months.
- •11.Patients with concurrent serious cardiac, 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.
- •12.Patients with Diabetes Mellitus
- •13.Alcoholics and/or drug abusers.
- •14.Patients with evidence of malignancy
- •15.Patients suffering from major systemic illness necessitating long term drug treatment/Auto-Immune disorders (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
- •16.Pregnant or lactating woman.
- •17.H/o hypersensitivity to any of the trial drugs or their ingredients
- •18.Patients who have completed participation in any other clinical trial during the past
- •Six (06) months.
- •19.Patients on calcium and Vitamin D supplementation.
- •20.Patients with history of Urolithiasis.
- •21.Known cases of Pagetâ??s disease of bone
- •22.Any other condition which the investigator thinks may jeopardize the study.
研究者
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