| CTRI Number |
CTRI/2022/11/047114 [Registered on: 07/11/2022] Trial Registered Prospectively |
| Last Modified On: |
08/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect and safety of KSM-66 Ashwagandha (Withania somnifera) in elderly subjects for General Health Improvement |
|
Scientific Title of Study
|
Efficacy and Safety of KSM66 Ashwagandha (Withania somnifera) in Elderly for General health Improvement: A prospective, Randomized, Double-Blind, Placebo-Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KSM/GH/Eld/03/2019 Version 3.0 dt 01-12-2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R S Honnutagi |
| Designation |
Principal Investigator |
| Affiliation |
Shri B. M. Patil Medical hospital & Research center |
| Address |
B. M. Patil Medical Hospital & Research Center, B. M. Patil Medical college, Solapur Road, Vijayapura, Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9845298037 |
| Fax |
|
| Email |
r.honnutagi@bldedu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R S Honnutagi |
| Designation |
Principal Investigator |
| Affiliation |
Shri B. M. Patil Medical hospital & Research center |
| Address |
B. M. Patil Medical Hospital & Research Center, B. M. Patil Medical College, Solapur Road, Vijayapura, Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9845298037 |
| Fax |
|
| Email |
r.honnutagi@bldedu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr R S Honnutagi |
| Designation |
Principal Investigator |
| Affiliation |
Shri B. M. Patil Medical hospital & Research center |
| Address |
B. M. Patil Medical Hospital & Research Center, B. M. Patil Medical college, Solapur Road, Vijayapura, Karnataka
Bijapur
KARNATAKA
586103
India |
| Phone |
9845298037 |
| Fax |
|
| Email |
r.honnutagi@bldedu.ac.in |
|
|
Source of Monetary or Material Support
|
| Ixoreal Biomed Private Limited
5-9-225, Sanali Estate, Abids, Hyderabad - 500001 Ph: (91)
40-23204385 / 86 / 87 India
|
|
|
Primary Sponsor
|
| Name |
Ixoreal Biomed Private Limited |
| Address |
Shri Kartikeya Pharma, 5-9-225, Sanali Estate, Abids, Hyderabad - 500001 Ph: (91) 40-23204385 / 86 / 87 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr RS Honnutagi |
Shri B. M. Patil Medical hospital & Research center |
B. M. Patil Medical Hospital & Research Center, B. M. Patil Medical college, Solapur Road, Vijayapura, Karnataka- 586103 Bijapur KARNATAKA
Bijapur
KARNATAKA |
9845298037
r.honnutagi@bldedu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI. B. M. PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTER, VIJAYAPURA BLDE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Elderly healthy condition |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
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 |
| Comparator Agent |
Capsule identical to study
capsule |
One capsule Contains 300 mg starch. one capsule to be taken orally with water two times daily for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 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
|
| Outcome |
TimePoints |
| Improvement in the score of Addenbrookes Cognitive Examination-Revised (ACE-R) |
Baseline, 4 weeks, 8 weeks |
| Improvement in the global score of The Epworth Sleepiness Scale (ESS) |
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 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2022 |
| Date of Study Completion (India) |
13/04/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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 |