RECRUITING

Safety of Ashwagandha (Withania Somnifera) Root Extract

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety of Ashwagandha (Withania Somnifera) Root Extract: An Open-Label, Non-Comparative, Prospective Study in Healthy Subjects

Quick Facts

Study Start:2024-02

Study Completion:2024-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06261476

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Locations (Sites)

SF Research Institute

San Francisco, California, 94127

United States

Collaborators and Investigators

Sponsor: SF Research Institute, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02

Study Completion Date2024-05

Study Record Updates

Study Start Date2024-02

Study Completion Date2024-05

Terms related to this study

Additional Relevant MeSH Terms

Healthy