None listed
Conditions
Interventions
Intervention1: KSM-66 capsules containing
Ashwagandha 300 mg standardized root extract: Standardized root extract 300
mg to be taken two times in a
day orally with water/milk for
period of 12 months
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE)Timepoint: Baseline, 6 months, 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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, 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 | — |
Countries
India
Contacts
Public ContactDeepakkumar Langade
D Y Patil Medical College Hospital and Research Centre
Outcome results
None listed