Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06244147
Status:
RECRUITING
Last Update Posted:
2024-02-14
First Post:
2024-01-24
Brief Title:
Long Term Safety and Efficacy of KSM-66 Ashwagandha in Adults
Sponsor:
SF Research Institute Inc
Organization:
SF Research Institute Inc
Study Overview
Official Title:
Long Term Safety and Efficacy of KSM-66 Ashwagandha Standardized Root Extract of Withania Somnifera in Adults A Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective is to evaluate the clinical safety of KSM-66 Ashwagandha Withania Somnifera on long-term administration over 12 months The secondary objectives are to evaluate the laboratory safety of KSM-66 Ashwagandha Withania Somnifera on long-term administration over 12 months and to evaluate the efficacy of KSM-66 Ashwagandha Withania Somnifera on long-term administration over 12 months
Detailed Description:
To qualify for this study participant must be male or female between 18 and 65 years old and prescribed KSM-66 Ashwagandha by their clinicians for a long-term period Participants must have no plan to commence any other alternative treatment modality for their conditions Participants must be willing to sign an informed consent document and to comply with all study related procedures Participants must have a body mass index between 25 and 399 kgm2
In this study a total of 200 subjects will be included across 4-5 study sites for a total duration of 12 months At the initial visit prospective patients will be screened for enrollment based on the requirements of the study medical history and clinical examination Before starting any study related procedures participants will be explained about the study in detail and a written informed consent will be obtained from participants prior to participation in this study This document is a part of the written informed consent procedure A detailed medical history including the associated conditions will be recorded A general and physical examination will be performed to detect any abnormal parameters If participants meet the eligibility criteria they will be enrolled in the study
After enrollment in the study participants will be asked to consume Ashwagandha 300 mg root extract capsule orally twice daily morning and evening after breakfast and dinner with a glass of water At Visit 1 ScreeningEnrollmentBaseline Visit - Day -3 to Day 0 demography and medical history will be taken physical examination and vital signs will be performed blood will be collected study medication will be dispensed and Clinical Global Impression - Improvement CGI-I scale and Quality of Life using the SF-12 QoL scale will be assessed
At Visits 2 to 6 Months 1 2 3 4 5 participants will follow up remotely via a phone call Compliance and concomitant medication will be noted
At Visit 7 Month 7 participants will follow up on site where a physical examination and vital signs will be performed blood will be collected study medication will be dispensed Clinical Global Impression - Improvement CGI-I scale and Quality of Life using the SF-12 QoL scale will be assessed and compliance will be assessed
At Visits 8 to 12 Months 7 8 9 10 11 participants will follow up remotely via a phone call Compliance and concomitant medication will be noted
At Visit 13 Final Visit - Month 12 participants will follow up on site where a physical examination and vital signs will be performed blood will be collected Clinical Global Impression - Improvement CGI-I scale and Quality of Life using the SF-12 QoL scale will be assessed and compliance will be assessed Participants will be monitored throughout the study including any adverse events
In this study a total of 200 subjects will be included across 4-5 study sites for a total duration of 12 months At the initial visit prospective patients will be screened for enrollment based on the requirements of the study medical history and clinical examination Before starting any study related procedures participants will be explained about the study in detail and a written informed consent will be obtained from participants prior to participation in this study This document is a part of the written informed consent procedure A detailed medical history including the associated conditions will be recorded A general and physical examination will be performed to detect any abnormal parameters If participants meet the eligibility criteria they will be enrolled in the study
After enrollment in the study participants will be asked to consume Ashwagandha 300 mg root extract capsule orally twice daily morning and evening after breakfast and dinner with a glass of water At Visit 1 ScreeningEnrollmentBaseline Visit - Day -3 to Day 0 demography and medical history will be taken physical examination and vital signs will be performed blood will be collected study medication will be dispensed and Clinical Global Impression - Improvement CGI-I scale and Quality of Life using the SF-12 QoL scale will be assessed
At Visits 2 to 6 Months 1 2 3 4 5 participants will follow up remotely via a phone call Compliance and concomitant medication will be noted
At Visit 7 Month 7 participants will follow up on site where a physical examination and vital signs will be performed blood will be collected study medication will be dispensed Clinical Global Impression - Improvement CGI-I scale and Quality of Life using the SF-12 QoL scale will be assessed and compliance will be assessed
At Visits 8 to 12 Months 7 8 9 10 11 participants will follow up remotely via a phone call Compliance and concomitant medication will be noted
At Visit 13 Final Visit - Month 12 participants will follow up on site where a physical examination and vital signs will be performed blood will be collected Clinical Global Impression - Improvement CGI-I scale and Quality of Life using the SF-12 QoL scale will be assessed and compliance will be assessed Participants will be monitored throughout the study including any adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None