CTRI/2020/04/024684进行中（未招募）3 期
An open labelled trial to study the safety and efficacy of Vitamin K2-7 in Human Osteoporosis
SSV Phytopharmaceuticals1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年4月16日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in Pain Score on the basis of Visual Analog Scale (VAS)
研究概览
简要总结
The objective of the study is to investigate efficacy and safety of Vitamin K2-7 in the management of pain due to Osteoporosis.
Primary outcome- Reduction in Pain Score on the basis of Visual Analog Scale (VAS) within 30 days
Secondary outcome: Safety, Efficacy and Tolerability
N= 30
Osteocalcin Measurement (ucOC and COC) in 10 patients will be done at baseline and at the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Men and non-pregnant women who are at least 20 years and under 75 years of age; and 2.The osteoporosis diagnosed by standard DXA measurement (BMD T-score:.
- •2.5 or below); and 3.Pain defined by a level of greater than or equal to 4 on Visual Analogue Scale (VAS).
- •Patients who are, in the opinion of the Investigator, able to comply with the requirements of the study; and 5.Patients who have been adequately informed of the nature and risks of the study and who have given written informed consent prior to receiving study medication.
排除标准
- •1.Women who are pregnant, as determined by a urine pregnancy test, or breast-feeding.
- •2.Presence or history of congestive heart failure (NYHA class III/IV) within the prior 12 weeks.
- •3.Recent myocardial infarction (within the prior 12 weeks).
- •4.Unstable angina pectoris.
- •5.Known or suspected renal insufficiency defined as creatinine>1.5mg/dl.
- •6.Known or suspected hepatic insufficiency defined as abnormal liver function tests (GOT/GPT) >3x upper normal limit (i.e., 120 U/l).
- •7.Known hypomotility syndrome: (such as hypothyroidism or scleroderma).
- •8.Recent major trauma within the prior 12 weeks.
- •10.Recent hospitalization (within 12 weeks).
结局指标
主要结局
Reduction in Pain Score on the basis of Visual Analog Scale (VAS)
时间窗: 30 days
次要结局
- Safety and Efficacy(30 days)
研究者
研究点 (1)
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