CTRI/2012/03/002533招募中2 期
Clinical Evaluation of Laksha Guggulu and Mukta Shukti Pishti in the Management of Osteopenia/Osteoporosis. - IMCRP-OP-2010-2011
Central Council for Research in Ayurvedic Sciences CCRAS0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
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.B.M.D.T-. Score of < -1
- •2.Willing and able to participate for 16 weeks
排除标准
- •1. Patients who are consuming any drug which is known to affect bone metabolism for e.g. SERMs, bisphophonates, 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 with history of Fragility Fracture.
- •3. Patients suffering from congenital disorders (Dysosteogenesis and Marfanâ??s Syndrome)
- •4. Patients with endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushingâ??s syndrome)
- •5. Patients with poorly controlled Hypertension ( > 160 / 100 mm Hg)
- •6. Patients suffering from Osteomalacia.
- •7. Patients whose Serum Ca++ level < 2.2 or > 2.6 mmol/L ( < 9 or >10.5 mg/dL)
- •8. Patients suffering from Malabsorption syndrome
- •9. Patients who have undergone Organ transplantation
- •10. Patients who are immobilized since > 6 weeks
- •11. Patients with history of Long bone fracture in last 6 months.
- •12. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •13. Symptomatic patient with clinical evidence of Heart failure.
- •14. 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.
- •15. Patients with poorly controlled Diabetes Mellitus (HbA1c > 10%)
- •16. Alcoholics and/or drug abusers.
- •17. Patients with evidence of malignancy
- •18. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Psycho-Neuro-Endocrinal disorders, etc.)
- •19. Pregnant or lactating woman.
- •20. H/o hypersensitivity to any of the trial drugs or their ingredients
- •21. Patients who have completed participation in any other clinical trial during the past
- •six (06) months.
- •22. Any other condition which the P.I. thinks may jeopardize the study.
研究者
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