Effect and safety of KSM-66 Ashwagandha (Withania somnifera) in elderly subjects for General Health Improvement

Completed

• Conditions: Elderly healthy condition

• Registration Number: CTRI/2022/11/047114
• Lead Sponsor: Ixoreal Biomed Private Limited

Brief Summary

This is single-center study to compare the effect of Ashwagandha extract 600 mg/day with placebo for its effect on healthy male and female adult elderly individuals.

Enrolled subjects will receive one capsule of Ashwagandha (300 mg) or identical placebo capsule two times daily with water for a period of 8 weeks.

Primary efficacy outcomes are the quality of life (QOL) that will be measured at baseline to end of the treatment.

Secondary efficacy outcomes are Addenbrookes Cognitive Examination-Revised (ACE-R), Epworth Sleepiness Scale (ESS), and Senior Fitness Test (SFT) for improvement assessment respectively. This all assessments will be measured at baseline to the end of treatment.

Safety outcomes will be based on clinical safety assessed by the adverse events reported. Global Assessment of Tolerability to Therapy (PGATT) will be assessed at the end of treatment

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-11
• Study Completion: 2024-04-13
• Last Update Posted: 2024-08-08

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

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

• 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)	Baseline, 4 weeks, 8 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement in the score of Addenbrookes Cognitive Examination-Revised (ACE-R)	Baseline, 4 weeks, 8 weeks
Improvement in the score for Senior Fitness Test (SFT)	Baseline, 4 weeks, 8 weeks
Global Assessment of Tolerability to Therapy (PGATT) on a 5-point scale	8 weeks
Improvement in the global score of The Epworth Sleepiness Scale (ESS)	Baseline, 4 weeks, 8 weeks

Trial Locations

Locations (1)

Shri B. M. Patil Medical hospital & Research center; 🇮🇳 Bijapur, KARNATAKA, India

Shri B. M. Patil Medical hospital & Research center

🇮🇳Bijapur, KARNATAKA, India

Dr RS Honnutagi

Principal investigator

9845298037

r.honnutagi@bldedu.ac.in