To evaluate effect of KSM-66 Ashwagandha® Capsule (300 mg) in Management of Frailty in Older Adults

Phase 3

Completed

• Conditions: Frailty

• Registration Number: CTRI/2022/02/040554
• Lead Sponsor: Ixoreal Biomed

Brief Summary

The currentstudy was planned to evaluate the effectivenessof KSM-66 Ashwagandha® capsule (300 mg) compared toidentical Placebo capsule in improving frailty of old adults.

Fifty older frailpatients aged will be included in this study. Patients will be enrolled intothe study based on Inclusion & Exclusion Criteria, patient history, andsafety measures. The duration of each patient’s participation in the study willbe of 56 days. There will be total 02 site visits and 01 telephonic interviewduring the study.

Onscreening/baseline visit, written informed consent will be obtained fromsubjects for their participation in the study. Subject’s history will berecorded and her physical examinations will be done. Subject will be recruitedin the study if he/she meets all the inclusion criteria. Subjects will undergogeneral and systemic examinations. At baseline visit and end of treatmentvisit, subjects will be provided with diary card to record daily symptoms. Allsubjects will be advised to continue their routine diet and physicalactivities.

Subjects will be called to the study centre onBaseline & 56 the day from the baseline visit. On every physical visit,subjects will undergo general and systemic examinations and assessment ofclinical symptoms will be done.  Therewill be a telephonic follow-up visit on Day 28 to check IP and ProtocolCompliance along with the AE detail collection.

Subjectswill be randomized to either one of the two treatment arms. Subjects will be instructedto take the one capsule of study medication to which they are randomized, twicea day after breakfast and dinner, with ambient temperature water for 56consecutive days at home. All the patients will be closely monitored for anyAdverse Events starting from baseline visit till the end of the study visit.After completion of 56 days of study treatment, all the subjects will be askedto stop trial medication and take advice of investigator for further treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-28
• Study Completion: 2022-11-26
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

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

Inclusion Criteria

1.Community-dwelling ≥60 years of age 2.Patient who can and willing to provide written Informed Consent 3.Patient with Frailty score of ≥7 based on FAST with normal cognition 4.Patient with at high risk for mobility disability/ functional limitations as assessed by the investigator 5.Patient able to independently ambulate 6.Patient who has received medical clearance from the investigator 7.Patient having capability of complete compliance and completion of follow-up 8.Patient who agree to take investigational product (IP) till Day 56 9.Patient/ patient’s legally acceptable representative understands and can comply with clinical trial protocol requirements.

Exclusion Criteria

• Patient is currently under the inpatient-care of a geriatrician 2.
• Patient with significant cognitive impairment/Severe mental disorder determined by the investigator 3.
• Patient receiving palliative/end of life care/ life expectancy ≤6 months 4.
• Patients with MMSE score ≤ 20 points 5.
• Patient having a history or presence of clinically significant cardiovascular, renal, metabolic, haematological, neurological, psychiatric, systemic, or infectious disease or malignant tumour.
• Patients with history of alcoholism or substance abuse.
• Patient who is not willing to take investigational product.
• 8.Patient who had recent hospitalization for major illness or elective surgery within 1-year of the start date of study.
• 9.Patient with any acute illness at the time of enrolment 10.Patient who has participated in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements, 1 month prior to this trial 11.Patient having an history of allergic reactions or anaphylaxis to investigational product components 12.Any other condition which the principal investigator thinks may jeopardize the safety of subjects—patients with uncontrolled, unstable comorbidities 13.Patients who had participated in other clinical trials during previous 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the mean change of Frailty Score (FAST- Frailty Assessment and Screening Tool) between active and placebo groups	Baseline and Day 56

Secondary Outcome Measures

Name	Time	Method
1.Change in 6-MIN walk test between baseline and Day 56	2.Assessment of PSQI (Pittsburgh Sleep Quality Index) between groups

Trial Locations

Locations (1)

Govt. Medical College & Govt. General Hospital (Old RIMSGGH); 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Govt. Medical College & Govt. General Hospital (Old RIMSGGH)

🇮🇳Srikakulam, ANDHRA PRADESH, India

Dr K Sunil Naik

Principal investigator

9440828299

rimsresearch@gmail.com