CTRI/2023/09/057461招募中2/3 期
Open randomized controlled clinical trail to evaluate the efficacy of osto-guard granules asthishrunkhala with milk in low bone mineral density levels in post menopausal women
Dr Rutuja Raghunath More1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年9月18日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- To evaluate the effect of osto guard granules asthishrunkhala with milk in low bone mineral density that is bmd levels in postmenopausal women
研究概览
简要总结
Menopause is a estrogen deficient phase due to reduced ovarian function which causes low bone mineral density
Current study is randomized controlled clinical trial to check the effectiveness of Osto-guard Granules ie Asthishrunkhala in the management of low bone mineral density in postmenopausal women
Study consist of two groups A and B
Group A Osto-Guard Granules 5gms with milk twice a day after meal
Group B Tab.Calcium 500mg with water once a day in morning
Both for 60 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 45.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- Female
入选标准
- •1 Cases having onset of Menopause within 10 yrs with Bone Mineral Density below minus 1 SD 2 Patients of any occupation religion and socio economic conditions.
排除标准
- •1 Patients diagnosed with osteoporosis BMD less than -2.5 SD 2 Premature ovarian failure Loss of normal functions of ovaries before the age of 40 years 3 Surgical menopause that is Hysterectomy 4 Endocrine disorders like Thyroid disease 5 Pagets disease 6 Malignancy 7 Postmenopausal bleeding.
结局指标
主要结局
To evaluate the effect of osto guard granules asthishrunkhala with milk in low bone mineral density that is bmd levels in postmenopausal women
时间窗: 8 Weeks
次要结局
- To observe the effect of osto guard granules with milk on serum calcium levels(8 weeks)
研究者
研究点 (1)
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