Clinical trial NCT06244147: Long Term Safety and Efficacy of KSM-66 Ashwagandha in Adults
Official title: Long Term Safety and Efficacy of KSM-66 Ashwagandha (Standardized Root Extract of Withania Somnifera) in Adults: A Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: All
Lead sponsor: SF Research Institute, Inc.
Sponsor class: NETWORK
First posted: 2024-02-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Liver Parameters
timeFrame: 6 and 12 months
measure: Liver Parameters
timeFrame: 6 and 12 months
measure: Liver Parameters
timeFrame: 6 and 12 months
measure: Liver Parameters
timeFrame: 6 and 12 months
measure: Renal Parameters
timeFrame: 6 and 12 months
measure: Muscle Parameters
timeFrame: 6 and 12 months
measure: Sex Hormones
timeFrame: 6 and 12 months
measure: Muscle Parameters
timeFrame: 6 and 12 months
measure: Thyroid Parameters
timeFrame: 6 and 12 months
measure: Serum Cortisol and Testosterone
timeFrame: 6 and 12 months
measure: Clinical Global Impression
timeFrame: 6 and 12 months
measure: Quality of Life Score
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: SF Research Institute
state: California
Study officials:
References: