TO Find the Effect of LIONâ€™S MANE CAPSULE as Nutritional Supplement

Phase 2/3

Completed

Conditions: Diabetes mellitus due to underlying condition without complications. Ayurveda Condition: Systemic hypertension or Diabetes Mellitus or Hyperlipidemia.,

Brief Summary: Totally 24 subjects who fulfilled the inclusionand exclusion criteria will be enrolled in the study. The selected subjectswill receive 3 capsules of Lionâ€™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.

Recruitment & Eligibility

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

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 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.
Participation in an investigational drug trial in the 30 days prior to the screening visit.

Primary Outcome Measures

Name	Time	Method
1. Improvement in the nutritional status based on Malnutrition screening	Day 0 and 28
tool, Mini Nutritional assessment & DETERMINE Your nutritional	Day 0 and 28
health checklist. [Baseline, week 4]	Day 0 and 28
2. Improvement in Cognitive function by using Montreal Cognitive Assessment [Baseline, week 4]	Day 0 and 28

Secondary Outcome Measures

Name	Time	Method
1.Improvement in BMI and mid arm circumference and Various	hematological and biochemical blood parameter will be monitored

Locations (2): PM Medical Centre Vellore
🇮🇳
Vellore, TAMIL NADU, India
Thirumalai Clinic and Raghavendra Diagnostic Centre
🇮🇳
Pondicherry, PONDICHERRY, India
PM Medical Centre Vellore
🇮🇳Vellore, TAMIL NADU, India
Dr Ramesh Kannan
Principal investigator
9677786447
srkguruvarshan@gmail.com