Efficacy and Long Term Safety of Ashwagandha in Adults

Not Applicable

Recruiting

Registration Number: CTRI/2022/10/046180

Lead Sponsor: Ixoreal Biomed Private Limited

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1. Adults (male and female) aged between 18 and 65 years

2. Prescribed KSM-66 Ashwagandha by their clinicians for long-term period

3. No plan to commence any other alternative treatment modality for their conditions

4. Willingness to sign an informed consent document and to comply with all study related procedures

Exclusion Criteria

1. Patients receiving any of the medications known to affect stress and anxiety (corticosteroids, antidepressants, antipsychotics, mood stabilizers, and anti-epileptic medications) during 4 weeks prior to screening.

2. 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.

3. Patients with depressive episode, suicidal tendency, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania

4. Patients with known post-traumatic stress disorder (PTSD)

5. Patients with known clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study

6. Patients with known hypersensitivity to Ashwagandha

7. Patients who had participated in other clinical trials during previous 3 months

8. Patients who have any clinical condition, according to the investigator which does not allow safe fulfilment of clinical trial protocol

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event <br/ ><br>(TESAE)Timepoint: Baseline, 6 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in the Quality of Life (SF-12 QoL)Timepoint: 6 months, 12 months;Changes in laboratory values for liver parameters (serum alanine transaminase, <br/ ><br>aspartate transaminase, alkaline phosphatase, bilirubin)Timepoint: Baseline, 6 months, 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)Timepoint: Baseline, 6 months, 12 months;Changes in laboratory values for renal parameters (serum creatinine, blood urea nitrogen)Timepoint: Baseline, 6 months, 12 months;Changes in laboratory values for serum cortisol and serum testosteroneTimepoint: Baseline, 6 months, 12 months;Changes in laboratory values for thyroid parameters (serum TSH, T3 and T4)Timepoint: Baseline, 6 months, 12 months;Clinical Global Impression - Improvement scale (CGI-I)Timepoint: 6 months, 12 months