To Find the Effect of LION’S MANE TABLET as a Nutritional Supplement
Phase 2/3
Completed
- Conditions
- Diabetes mellitus due to underlying condition without complications. Ayurveda Condition: Systemic hypertension or Diabetes Mellitus or Hyperlipidemia.,
- Registration Number
- CTRI/2022/03/040733
- Lead Sponsor
- DXN Manufacturing India Pvt Ltd
- Brief Summary
The subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. The selected subjects will receive Lions’s Mane Tablet (Hericium Erinaceus) two tablets each three times after breakfast, lunch and dinner daily for 4 weeks. The Patients will be on standard treatment for other co morbid conditions as per standard guidelines.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
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.
- 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.
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 tool, Mini Nutritional assessment & DETERMINE Your nutritional health checklist. [Baseline, week 4] Day 0 and 28 2.Improvement in Cognitive function by using Montreal Cognitive Assessment [Baseline and 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 2.Adverse event monitoring
Trial Locations
- Locations (2)
PM Medical Centre Vellore
🇮🇳Vellore, TAMIL NADU, India
Smiriti’s Clinic
🇮🇳Kancheepuram, TAMIL NADU, India
PM Medical Centre Vellore🇮🇳Vellore, TAMIL NADU, IndiaDr Ramesh KannanPrincipal investigator9677786447srkguruvarshan@gmail.com