TO Find the Effect of LION�S MANE CAPSULE as Nutritional Supplement
- Conditions
- Health Condition 1: E089- Diabetes mellitus due to underlying condition without complications
- Registration Number
- CTRI/2022/03/040725
- Lead Sponsor
- DXN Manufacturing India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
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.
1. Participants presenting with fever and acute infections, will be excluded.
2. History of heart, liver or kidney failure.
3. Allergy or intolerance to the individual constituents in test product.
4. Patients with history of thyroid abnormalities.
5. Patients with history of any malignancy
6. History of any Neurodegenerative disease
7. Organ transplantation
8. Allergy to fungi
9. Subjects who are pregnant and lactating mothers, or with any serious
disease condition limiting full adhesion to the protocol.
10. Participation in an investigational drug trial in the 30 days prior to the
screening visit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Improvement in the nutritional status based on Malnutrition screening <br/ ><br>tool, Mini Nutritional assessment & DETERMINE Your nutritional <br/ ><br>health checklist. [Baseline, week 4] <br/ ><br>2. Improvement in Cognitive function by using Montreal Cognitive Assessment [Baseline, week 4]Timepoint: Day 0 and 28
- Secondary Outcome Measures
Name Time Method 1.Improvement in BMI and mid arm circumference and Various <br/ ><br>hematological and biochemical blood parameter will be monitored <br/ ><br>2. Adverse event monitoringTimepoint: Day 0 and 28