Clinical trial NCT06261476: Safety of Ashwagandha (Withania Somnifera) Root Extract
Official title: Safety of Ashwagandha (Withania Somnifera) Root Extract: An Open-Label, Non-Comparative, Prospective Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy
Lead sponsor: SF Research Institute, Inc.
Sponsor class: NETWORK
First posted: 2024-02-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Hemoglobin Test
timeFrame: 12 weeks
measure: Total Erythrocyte Count
timeFrame: 12 weeks
measure: Total Leukocyte Count
timeFrame: 12 weeks
measure: Platelet Count
timeFrame: 12 weeks
measure: Hematocrit Test
timeFrame: 12 weeks
measure: Total Cholesterol Test
timeFrame: 12 weeks
measure: LDL Test
timeFrame: 12 weeks
measure: HDL Test
timeFrame: 12 weeks
measure: Triglycerides Test
timeFrame: 12 weeks
measure: Serum Alkaline Transaminase Test
timeFrame: 12 weeks
measure: Aspartate Transaminase Test
timeFrame: 12 weeks
measure: Alkaline Phosphatase Test
timeFrame: 12 weeks
measure: Bilirubin Test
timeFrame: 12 weeks
measure: Serum Creatinine Test
timeFrame: 12 weeks
measure: Blood Urea Nitrogen Test
timeFrame: 12 weeks
measure: T4
timeFrame: 12 weeks
measure: T3
timeFrame: 12 weeks
measure: Serum TSH
timeFrame: 12 weeks
measure: Fasting Blood Sugar
timeFrame: 12 weeks
measure: HbA1c
timeFrame: 12 weeks
Secondary outcomes:
measure: Adverse Events
timeFrame: 12 weeks
measure: Quality of Life (SF-36 QoL)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: SF Research Institute
state: California
Study officials:
References: