CTRI/2021/06/034249尚未招募2 期
An Open Labeled Single Group Proof of Concept Study to Evaluate the Efficacy & Safety of Myostaal SB Tablets in Participants Suffering with Osteopenia
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
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.Participant of either sex in the age group of 40-75 years (both years inclusive).
- •2.Participantâ??s suffering from Osteopenia with BMD T- score between (-1 to -2.5)
- •3.Participantâ??s with a history of fractures that may have occurred with a minor injury or fall.
- •4.Participantâ??s willing to give written informed consent.
- •5.Participantâ??s willing to follow up.
排除标准
- •1.Participantâ??s consuming any drug known to affect bone metabolism e.g. SERMs, bisphosphonates, calcitonin, Vit.D (more than 60,000 units), methotrexate, anti-epileptic drugs, loop diuretics, corticosteroids (more than 5mg/day of prednisolone or equivalent) etc for more than 3 months.
- •2.Participantâ??s with Serum Ca2+ level is either < 2.2 or > 2.6 mmol/L ( < 9 or >10.5 mg/dL)
- •3.Participant suffering from Osteomalacia, Tumor, Osteonecrosis, osteomyelitis or any other bone-softening metabolic disorders.
- •4.Participantâ??s suffering from congenital disorders (Dysosteogenesis and Marfanâ??s Syndrome)
- •5.Participantâ??s with documented history of Leukemia, Lymphoma, Metastases (bony and other), Pathologic fractures secondary to bone metastases from cancer, Pediatric osteogenesis imperfecta or Renal osteodystrophy, Malabsorption syndrome
- •6.Participantâ??s with documented history of endocrine disorders (Hyperthyroidism, hyperparathyroidism, Untreated Cushingâ??s syndrome)
- •7.Participantâ??s with history of any Organ transplantation
- •8.Participantâ??s who are immobilized since > 6 weeks
- •9.Participantâ??s who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, heart failure Stroke or Severe Arrhythmia in the last 6 months.
- •10.Participantâ??s with auto-immune disease, uncontrolled hypertension, Diabetes mellitus requiring insulin injections and chronic severe respiratory disease.
- •11.Participantâ??s who may require treatment of oral and/or injectable steroids or surgical intervention during the course of study duration.
- •12.Participantâ??s with history of clinically-active renal, hepatic or peptic ulcer disease
- •13.History of life threatening cardiovascular and /or neurological event in the past one year.
- •14.Participantâ??s having any severe active infectious disease requiring hospitalization.
- •15.Participantâ??s who has undergone or who is planning to undergo surgery in next 3 months will be excluded from the study
- •16.Participantâ??s with abnormal Hb/CBC values, 10% beyond the normal range will lead to exclusion of the participant from the study.
- •17.Participantâ??s with hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as Sr. creatinine > 1.2mg/dl).
- •18.Participantâ??s with uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients)
- •19.Participantâ??s with history of alcohol or drug abuse.
- •20.Pregnant and lactating women.
- •21.Participantâ??s receiving any other treatment for Osteopenia other than vitamin supplements.
- •22.Participant who has taken study drug or any herbal medication in the past 4 weeks.
- •23.Participant with history of severe allergy or anaphylactic reaction.
- •24.Participant participating in another investigational drug trial in the previous 30 days.
- •25.Participantâ??s who cannot give valid consent such as mentally retarded, unconscious patients and psychiatric illness
- •26.Participant with documented history of positive screening result for hepatitis B and/or Hepatitis C virus.
- •27.Participant with documented history of HIV or any immune deficient conditions.
- •28.Any other condition which the P.I. thinks may jeopardize the study
研究者
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