All Clinical Trial
Official title:
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | February 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | SF Research Institute | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
SF Research Institute, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Liver Parameters | Changes in laboratory values for serum alanine transaminase 6 months and 12 months after start of KSM-66 Ashwagandha | 6 and 12 months | |
Secondary | Liver Parameters | Changes in laboratory values for aspartate transaminase 6 months and 12 months after start of KSM-66 Ashwagandha | 6 and 12 months | |
Secondary | Liver Parameters | Changes in laboratory values for alkaline phosphatase 6 months and 12 months after start of KSM-66 Ashwagandha | 6 and 12 months | |
Secondary | Liver Parameters | Changes in laboratory values for bilirubin 6 months and 12 months after start of KSM-66 Ashwagandha | 6 and 12 months | |
Secondary | Renal Parameters | 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 | |
Secondary | Muscle Parameters | Changes in laboratory values for serum creatine phosphokinase-MB 6 months and 12 months after start of KSM-66 Ashwagandha | 6 and 12 months | |
Secondary | Sex Hormones | Changes in laboratory values for serum testosterone 6 months and 12 months after start of KSM-66 Ashwagandha | 6 and 12 months | |
Secondary | Muscle Parameters | 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 | |
Secondary | Thyroid Parameters | 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 | |
Secondary | Serum Cortisol and Testosterone | 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 | |
Secondary | Clinical Global Impression | 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 | |
Secondary | Quality of Life Score | 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 |
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