CTRI/2017/05/008662招募中未知
Clinical evaluation of Laksha Guggulu, Muktasukti Bhasma in the management of Osteopeniea/ Osteoporosis
试验速览
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 with age above 45years and upto 70 years.
- •2.B.M.D.T. Score ( -1 to -3) on DEXA Scan
- •3.Patient willing to participate in the clinical trial
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 suffering from Osteomalacia.
- •6.Patients suffering from Malabsorption syndrome
- •7. Patients who have undergone Organ transplantation
- •8.Patients who are immobilized since > 6 weeks
- •9.Patients with history of bone fracture in last 6 months.
- •10.Patients with evidence of malignancy
- •11.Pregnancy and lactation
- •12.Patients who cannot report in person once in 2 weeks in the OPD
- •13.Patients with poorly controlled Hypertension ( >160/100 mmHg)
- •14.Patients with poorly controlled Diabetes Mellitus having Hb A1C of >8
- •15.Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 6 months.
- •16.Patients with history of Urolithiasis.
- •17.Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine >1.2mg/dl), Severe Pulmonary Dysfunction (uncontrolled Bronchial Asthma and / or Chronic Obstructive Pulmonary Disease [COPD]), or any other condition that may jeopardize the study.
- •18.Alcoholics, smokers, and/or drug abusers
- •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 months.
- •21.Patients on calcium and Vitamin D supplementation
- •22.Known cases of Pagetâ??s disease of bone.
- •23.Any other condition which the Investigator thinks may jeopardize the study.
研究者
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