CTRI/2022/03/040733
Completed
Phase 2
Clinical Study to Evaluate the Efficacy and Safety of LION�S MANE TABLET (HERICIUM ERINACEUS) as a Nutritional Supplement in Patients with Co morbidities.
DXN Manufacturing India Pvt Ltd0 sites24 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Health Condition 1: E089- Diabetes mellitus due to underlying condition without complications
- Sponsor
- DXN Manufacturing India Pvt Ltd
- Enrollment
- 24
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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