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临床试验/CTRI/2015/01/005406
CTRI/2015/01/005406已完成2 期

CLINICAL EVALUATION OF ASHWAGANDHA CHURNA AND PRAVALA PISHTI IN THE MANAGEMENT OF OSTEOPENIA/OSTEOPOROSIS

Central Council for Research in Ayurvedic Sciences CCRAS0 个研究点目标入组 90 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
90

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 between ( -1 to -3 ) on DEXA Scan.
  • 2. Willing and able to participate for 14 weeks

排除标准

  • 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 MellitusBlood sugar (fasting >126 and PP >200mg/dl)
  • 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

发起方
Central Council for Research in Ayurvedic Sciences CCRAS

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