Clinical Study to Evaluate the Efficacy and Safety of LION’S MANE CAPSULE (HERICIUM ERINACEUS) as Nutritional Supplement in Patients with Co morbidities.
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
Totally 24 subjects who fulfilled the inclusionand exclusion criteria will be enrolled in the study. The selected subjectswill receive 3 capsules of Lion’s ManeCapsule(Hericium Erinaceus) of DXN Manufacturing India Pvt. Ltd, Three times after breakfast, lunch anddinner daily for 4 weeks. The primaryand secondary outcome parameters will be assessed on respective time points andresults 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
- •1.Participants aged 18-60 years (both sex).
- •2.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
时间窗: Day 0 and 28
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)