Effect and safety of KSM-66 Ashwagandha (Withania somnifera) in elderly subjects for General Health Improvement
- Registration Number
- CTRI/2022/11/047114
- Lead Sponsor
- Ixoreal Biomed Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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