CTRI/2022/03/040724已完成2/3 期
CLinical Study TO Evaluate the Efficacy and Safety of LION’S MANE POWDER (HERICIUM ERINACEUS) as 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
研究概览
简要总结
Totally24 subjects who fulfilled the inclusion and exclusion criteria will be enrolledin the study. The selected subjects will receive 5g of Lion’s Mane Powder (Hericium Erinaceus)of DXN Manufacturing India Pvt. Ltd. once daily orallybefore food for 4 weeks. The primary and secondary outcome parameters will beassessed on respective time points and results will be analyzed statistically.
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 determined to be at risk for malnutrition based on the Malnutrition Screening Tool for adults and 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 thyroid abnormalities.
- •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
时间窗: Day 0 and 28
tool, Mini Nutritional assessment & DETERMINE Your 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)
研究者
研究点 (2)
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