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

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.

Conditions

All
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Study Overview

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Study Details

Study overview

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.

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

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

Condition
All
Intervention / Treatment

-

Contacts and Locations

San Francisco

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

SF Research Institute, Inc.,

Study Record Dates

2025-02