To Find the Effect of CORDYCEPS POWDER as a Nutritional supplement
Phase 2/3
Completed
- Conditions
- Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, Vyanabala vaishamya,
- Registration Number
- CTRI/2022/03/040721
- Lead Sponsor
- DXN Manufacturing India Pvt Ltd
- Brief Summary
Totally 24 subjects who fulfilled the inclusion and exclusion criteria will be enrolled in the study. The selected subjects will receive 5g of Cordyceps Powder (Cordyceps sinensis) of DXN Manufacturing India Pvt. Ltd. once daily orally before food for 4 weeks. The primary and secondary outcome parameters will be assessed on respective time points and results will be analyzed statistically.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Participants aged 18-60 years (both sex).
- Participants who are 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 abnormal thyroid 5.
- Patients with history of any malignancy.
- 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.
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 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 Day 0 and 28 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
Trial Locations
- 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, IndiaDr Ramesh Kannan MDPrincipal investigator9677786447srkguruvarshan@gmail.com