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

November 5, 2025 updated by: SF Research Institute, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To qualify for this study, participant must be male or female between 18 and 65 years old and prescribed KSM-66 Ashwagandha by their clinicians for a long-term period. 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. Participants must have a body mass index between 25 and 39.9 kg/m2.

In this study, a total of 200 subjects will be included across 4-5 study sites, for a total duration of 12 months. 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 asked to consume Ashwagandha 300 mg root extract capsule orally twice daily, morning and evening after breakfast and dinner with a glass of water. 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, study medication will be dispensed, and Clinical Global Impression - Improvement (CGI-I) scale and Quality of Life using the SF-12 QoL scale will be assessed.

At Visits 2 to 6 (Months 1, 2, 3, 4, 5), participants will follow up remotely via a phone call. Compliance and concomitant medication will be noted.

At Visit 7 (Month 7), participants will follow up on site, where a physical examination and vital signs will be performed, blood will be collected, study medication will be dispensed, Clinical Global Impression - Improvement (CGI-I) scale and Quality of Life using the SF-12 QoL scale will be assessed, and compliance will be assessed.

At Visits 8 to 12 (Months 7, 8, 9, 10, 11), participants will follow up remotely via a phone call. Compliance and concomitant medication will be noted.

At Visit 13 (Final Visit - Month 12), participants will follow up on site, where a physical examination and vital signs will be performed, blood will be collected, Clinical Global Impression - Improvement (CGI-I) scale and Quality of Life using the SF-12 QoL scale will be assessed, and compliance will be assessed. Participants will be monitored throughout the study, including any adverse events.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94127
        • SF Research Institute

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

A total of 200 subjects who are prescribed KSM-66 Ashwagandha by their clinicians for long-term period for their respective health conditions will be included for this observational study.

Description

Inclusion 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adverse Events
Time Frame: 12 months
Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE) due to KSM-66 Ashwagandha (Withania Somnifera) over 12 months period
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Liver Parameters
Time Frame: 6 and 12 months
Changes in laboratory values for serum alanine transaminase 6 months and 12 months after start of KSM-66 Ashwagandha
6 and 12 months
Liver Parameters
Time Frame: 6 and 12 months
Changes in laboratory values for aspartate transaminase 6 months and 12 months after start of KSM-66 Ashwagandha
6 and 12 months
Liver Parameters
Time Frame: 6 and 12 months
Changes in laboratory values for alkaline phosphatase 6 months and 12 months after start of KSM-66 Ashwagandha
6 and 12 months
Liver Parameters
Time Frame: 6 and 12 months
Changes in laboratory values for bilirubin 6 months and 12 months after start of KSM-66 Ashwagandha
6 and 12 months
Renal Parameters
Time Frame: 6 and 12 months
Changes in laboratory values for renal parameters (serum creatinine, blood urea nitrogen) 6 months and 12 months after start of KSM-66 Ashwagandha
6 and 12 months
Muscle Parameters
Time Frame: 6 and 12 months
Changes in laboratory values for serum creatine phosphokinase-MB 6 months and 12 months after start of KSM-66 Ashwagandha
6 and 12 months
Sex Hormones
Time Frame: 6 and 12 months
Changes in laboratory values for serum testosterone 6 months and 12 months after start of KSM-66 Ashwagandha
6 and 12 months
Muscle Parameters
Time Frame: 6 and 12 months
Changes in laboratory values for muscle parameters (serum creatine phosphokinase-MB), thyroid parameters (serum TSH, T3 and T4), and sex hormones (serum testosterone) 6 months and 12 months after start of KSM-66 Ashwagandha
6 and 12 months
Thyroid Parameters
Time Frame: 6 and 12 months
Changes in laboratory values for thyroid parameters (serum TSH, T3 and T4) 6 months and 12 months after start of KSM-66 Ashwagandha
6 and 12 months
Serum Cortisol and Testosterone
Time Frame: 6 and 12 months
Changes in laboratory values for serum cortisol and serum testosterone 6 months and 12 months after start of KSM-66 Ashwagandha
6 and 12 months
Clinical Global Impression
Time Frame: 6 and 12 months
Clinical Global Impression - Improvement scale (CGI-I) score 6 months and 12 months after start of KSM-66 Ashwagandha [The CGI-I scale measures the change in the patient's clinical status from a specific point in time using a 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), with a score of 4 indicating no change]
6 and 12 months
Quality of Life Score
Time Frame: 6 and 12 months
Changes from baseline in the Quality of Life (SF-12 QoL) scores 6 months and 12 months after start of KSM-66 Ashwagandha
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SF Research Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 6, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Ixoreal-Safety-CT-06-22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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