Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06261476
Status:
RECRUITING
Last Update Posted:
2024-02-15
First Post:
2024-01-24
Brief Title:
Safety of Ashwagandha Withania Somnifera Root Extract
Sponsor:
SF Research Institute Inc
Organization:
SF Research Institute Inc
Study Overview
Official Title:
Safety of Ashwagandha Withania Somnifera Root Extract An Open-Label Non-Comparative Prospective Study in Healthy Subjects
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 laboratory safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy based on Complete Blood Count Renal Function Test Liver Function Test Lipid Profile and Thyroid Function Test Fasting blood sugar and HbA1c Test The secondary objectives are to evaluate the clinical safety of Ashwagandha standardized root extract 500 mg capsules in healthy adults over 12-week therapy and to evaluate the effect of the Ashwagandha standardized root extract 500 mg on Quality of Life QoL using the SF-36 tool
Detailed Description:
To qualify for this study participant must be a healthy male or female between 18 and 65 years old free from any chronic illness such as diabetic cardiovascular or any other conditions that could affect the safety of the study 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
In this study 100 subjects will be enrolled at 2 sites for a total duration of 12 weeks 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 assigned to take two capsules of Ashwagandha 500 mg twice daily after breakfast and dinner with ambient temperature water for 12 weeks 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 and the study medication will be dispensed
At Visit 2 Week 4 4 days and Visit 3 Week 8 4 days participants will return to the site for a followup A physical examination and vital signs will be performed blood will be collected study medication will be dispensed and compliance will be assessed
At Visit 4 Final Visit - Week 12 4 days physical examination and vital signs will be performed blood will be collected Quality of Life will be assessed using the SF-36 QoL scale and compliance will be assessed Participants will be monitored throughout the study including any adverse events At study completion participants are required to return any remaining testing products to the San Francisco Research Institute
In this study 100 subjects will be enrolled at 2 sites for a total duration of 12 weeks 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 assigned to take two capsules of Ashwagandha 500 mg twice daily after breakfast and dinner with ambient temperature water for 12 weeks 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 and the study medication will be dispensed
At Visit 2 Week 4 4 days and Visit 3 Week 8 4 days participants will return to the site for a followup A physical examination and vital signs will be performed blood will be collected study medication will be dispensed and compliance will be assessed
At Visit 4 Final Visit - Week 12 4 days physical examination and vital signs will be performed blood will be collected Quality of Life will be assessed using the SF-36 QoL scale and compliance will be assessed Participants will be monitored throughout the study including any adverse events At study completion participants are required to return any remaining testing products to the San Francisco Research Institute
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