CTRI/2018/01/011309尚未招募未知
A randomised, double blinded, comparative study to investigate the effectiveness & safety of Me-Cal in osteoporosis patients as compared to standard calcium supplement containing calcitrol, calcium and zinc.
SG PHYTO PHARMA PVT LTD0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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 complaining of classical symptoms of
- •joint pain, pain in the bones etc. which will
- •be confirmed later by the BMD-test with BMD
- •score below -1.
- •2. Patient agrees not to use any other calcium
- •supplement for osteoporosis other than what is
- •provided by the study.
- •3. Patient agrees to written informed consent.
- •4. Patient willing to participate in the study
- •for 12 weeks.
- •5. Patient who has not participated in any
- •clinical study in last 30 days.
排除标准
- •1.Planning to conceive, pregnant and lactating mothers.
- •2. Patient under osteoporosis treatment.
- •3. Patients suffering from heart disease.
- •4. Patients with severe renal impairment.
- •5. Patient with known metabolic bone disease such
- •as osteogenesis imperfecta, or currently
- •healing fractures of lumbar spine, hips or
- •6. Patient on current treatment with steroids or
- •chemotherapy.
- •7. History of malignancy
- •8. History of hypersensitivity to any of the investigational drugs.
- •9. History of psychiatric disorder that may impair the ability of subjects to provide written informed consent
- •10. Any medical condition, where the investigator feels participation in the study could be detrimental to the subjects overall well-being.
研究者
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