None listed
Conditions
Interventions
Intervention1: Ashwagandha extract 300 mg (KSM66 capsule)
: One capsule of KSM66 300 mg contains Ashwagandha extract. one capsule to be taken orally with water two times daily for 8 weeks
Control Inte
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males and females aged between 60-85 years of age. 2.ECOG Performance score 0 to 1. 3.Body mass index (BMI) 22-32 kg/m2. 4.Body weight =50 kg. 5.Willing to comply with protocol and likely to be compliant with prescribed product.
Exclusion criteria
Exclusion criteria: 1.Known renal insufficiency or failure at screening. 2.Current or previous positive documented history of any chronic inflammatory state including chronic infection like tuberculosis, leprosy, HIV etc., or collagen vascular disorder. 3.Use of hormone replacement therapy (with the exception of levothyroxine). 4.Uncontrolled hypertension [ > 140 Systolic and > 90 Diastolic]. 5.Uncontrolled diabetes mellitus [HbA1C >7%]. 6.Known hemorrhagic disorder and/or coagulation disorder, or clinically important bleeding within 90 days prior to screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in health status and quality of life (QOL) using Older People’s Quality of Life Questionnaire (OPQOL)Timepoint: Baseline, 4 weeks, 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Global Assessment of Tolerability to Therapy (PGATT) on a 5-point scaleTimepoint: 8 weeks;Improvement in the global score of The Epworth Sleepiness Scale (ESS)Timepoint: Baseline, 4 weeks, 8 weeks;Improvement in the score for Senior Fitness Test (SFT)Timepoint: Baseline, 4 weeks, 8 weeks;Improvement in the score of Addenbrookes Cognitive Examination-Revised (ACE-R)Timepoint: Baseline, 4 weeks, 8 weeks | — |
Countries
India
Contacts
Public ContactDr R S Honnutagi
Shri B. M. Patil Medical hospital & Research center
Outcome results
None listed