Safety of Ashwagandha (Withania Somnifera) Root Extract

NCT ID: NCT06261476

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2024-05-31

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 (Screening/Enrollment/Baseline 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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Ashwagandha (Withania somnifera) Root Extract

Participants will take two Ashwagandha capsules containing 500 mg standardized root extract twice daily after breakfast and dinner, for a duration of 12 weeks.

Group Type: EXPERIMENTAL

Ashwagandha (Withnia somnifera)

Intervention Type: DIETARY_SUPPLEMENT

Ashwagandha is the active ingredient in Withania somnifera (a medicinal plant in Indian medicine). Ashwagandha is known as an adaptogen, an herb in capsule form that protects the body from stress.

Interventions

Ashwagandha (Withnia somnifera)

Ashwagandha is the active ingredient in Withania somnifera (a medicinal plant in Indian medicine). Ashwagandha is known as an adaptogen, an herb in capsule form that protects the body from stress.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Both adults (male and female) aged between 18 and 65 years.
• Participant should be healthy and free from any chronic illness, such as diabetic, cardiovascular or any other condition that could affect the safety of the study.
• No plan to commence any other alternative treatment modality for their conditions.
• Willingness to sign an informed consent document and to comply with all study related procedures.

Exclusion Criteria

• History of Alcohol or smoking abuse.
• History of hypersensitivity to Ashwagandha.
• Taking nutritional or energy supplements, medication, or steroids.
• Any history of drug abuse.
• Having any clinical abnormalities.
• Simultaneously participating in any other clinical trial or participated in the past three months.
• Participants who use medication for blood pressure, use betablockers, inhaled any beta-agonists, use any hormonal contraceptives, having a history of corticosteroid use within three months, participants under psychotropic medication within last 8 weeks, and
• Participants diagnosed with any heart disease, diabetes, stroke, neurological disorders or depression.
• Have clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study.
• Patients with depressive episode, panic disorder, social phobia, obsessive-compulsory disorder, alcohol dependency; schizophrenia and mania.
• Patients with post traumatic disorder.
• Have an established practice of meditation for three or more months.
• Pregnant and lactating women.
• Participation in other clinical trials during previous 3 months.
• Any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

SF Research Institute, Inc.

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SF Research Institute

San Francisco, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

John Ademola, PhD

Role: primary

studyrecruitment@sfinstitute.com

415-549-9362

Other Identifiers

DYP-Pharm-RP-23

Identifier Type: -

Identifier Source: org_study_id