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

NCT06244147 | Completed

• 1 other identifier: Ixoreal-Safety-CT-06-22
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

All

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  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 Outcomes (12)

• Liver Parameters

  6 and 12 months

• Liver Parameters

  6 and 12 months

• Liver Parameters

  6 and 12 months

• Liver Parameters

  6 and 12 months

• Renal Parameters

  6 and 12 months

Interventions

KSM-66 Ashwagandha Root Extract DIETARY_SUPPLEMENT

Participants will take KSM-66 Ashwagandha root extract 300mg twice a day for the duration of the study.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SF Research Institute, Inc.: lead

Study Sites (1)

SF Research Institute

San Francisco, California, 94127, United States

Location

Related Publications (1)

• Salve J, Kale S, Prajapati BL, Sparavigna A, Savant M, Ademola J, Langade D. Safety of 12-Months Administration of Ashwagandha (Withania somnifera) Standardized Root Extract in Healthy Adults: A Prospective, Observational Study. Phytother Res. 2025 Oct 8. doi: 10.1002/ptr.70096. Online ahead of print.

  PMID: 41063394 DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 6, 2024
• Study Start: February 15, 2024
• Primary Completion: October 15, 2025
• Study Completion: October 15, 2025
• Last Updated: November 6, 2025

Record last verified: 2025-11

Locations

US (1)