COMPLETED

Long Term Safety and Efficacy of KSM-66 Ashwagandha in Adults

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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 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.

Official Title

Long Term Safety and Efficacy of KSM-66 Ashwagandha (Standardized Root Extract of Withania Somnifera) in Adults: A Prospective, Observational Study

Quick Facts

Study Start:2024-02-15

Study Completion:2025-10-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06244147

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
* Adults (male and female) aged between 18 and 65 years. * Prescribed KSM-66 Ashwagandha by their clinicians for long-term period. * 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. * Participants with Body mass index between 25 and 39.9 kg/m2.	* Patients receiving any of the medications known to affect stress and anxiety (corticosteroids, antidepressants, anti-psychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to screening. * Patients currently (or within the past 4 weeks prior to screening) taking any over the counter use of herbal extracts such as Ginkgo Biloba, St. John's Wort, Omega-3 etc. * Patients with depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania. * Patients with known post-traumatic stress disorder (PTSD). * Patients with known clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study. * Patients with known hypersensitivity to Ashwagandha. * Patients who had participated in other clinical trials during previous 3 months. * Patients who have any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol.

Inclusion Criteria

Exclusion Criteria

* Adults (male and female) aged between 18 and 65 years.
* Prescribed KSM-66 Ashwagandha by their clinicians for long-term period.
* 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.
* Participants with Body mass index between 25 and 39.9 kg/m2.

* Patients receiving any of the medications known to affect stress and anxiety (corticosteroids, antidepressants, anti-psychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to screening.
* Patients currently (or within the past 4 weeks prior to screening) taking any over the counter use of herbal extracts such as Ginkgo Biloba, St. John's Wort, Omega-3 etc.
* Patients with depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania.
* Patients with known post-traumatic stress disorder (PTSD).
* Patients with known clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study.
* Patients with known hypersensitivity to Ashwagandha.
* Patients who had participated in other clinical trials during previous 3 months.
* Patients who have 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 Date2024-02-15

Study Completion Date2025-10-15

Study Record Updates