CTRI/2022/03/040784已完成2/3 期
Clinical Study to Evaluate the Efficacy and Safety of Cordyceps Tablet (Cordyceps Sinensis) as a Nutritional Supplement in Patients with Co morbidities
DXN Manufacturing India Pvt Ltd2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年3月3日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- 1.Improvement in the nutritional status based on Malnutrition screening tool, Mini Nutritional assessment & Determine nutritional health checklist. [Baseline & week 4]
研究概览
简要总结
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. The selected subjects will receive Cordyceps tablets (Cordyceps sinensis) two tablets each three times after breakfast, lunch and dinner daily for 4 weeks. The patients will be on standard treatment for other co morbid conditions as per standard guidelines.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants aged 18-60 years (both sex).
- •Participants who are presenting with any one of the co morbidities like Systemic hypertension or Diabetes Mellitus or Hyperlipidemia.
排除标准
- •Participants presenting with fever and acute infections, will be excluded.
- •History of heart, liver or kidney failure.
- •Allergy or intolerance to the individual constituents in test product.
- •Patients with history of abnormal thyroid
- •Patients with history of any malignancy.
- •History of any Neurodegenerative disease
- •Organ transplantation
- •Allergy to fungi
- •Subjects who are pregnant and lactating mothers, or with any serious disease condition limiting full adhesion to the protocol.
- •Participation in an investigational drug trial in the 30 days prior to the screening visit.
结局指标
主要结局
1.Improvement in the nutritional status based on Malnutrition screening tool, Mini Nutritional assessment & Determine nutritional health checklist. [Baseline & week 4]
时间窗: Day 0 and 28
2.Improvement in Cognitive function by using Montreal Cognitive Assessment [Baseline & week 4]
时间窗: Day 0 and 28
次要结局
- 1.Improvement in BMI and mid arm circumference and Various hematological and biochemical blood parameter will be monitored(2.Adverse event monitoring)
研究者
研究点 (2)
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