None listed
Conditions
Interventions
Intervention1: Ashwagandha root extract (125mg): Consume Capsule containing Ashwagandha root extract (125mg) orally twice daily after breakfast and dinner (at bedtime, with a glass of water or milk)
I
Sponsors
Ixoreal Biomed Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults (male and female) aged between 18 and 65 years. 2.Experiencing signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.). 3.Participants with a Perceived Stress Scale (PSS) score =13 and without any other psychiatric conditions. 4.BMI between 20 and 35 kg/m2. 5.No plan to commence new treatments over the study period. 6. Medication-free (any medications are known to affect stress and anxiety) for at least 4 weeks. Use of analgesics (once a week) or contraceptive pills will be permissible. 7.Must have the ability and willingness to sign an informed consent and to comply with all study 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 a 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) and Generalized Anxiety Disorder (GAD). 5.Patients who have an established practice of meditation and relaxation techniques for three or more months. 6.Patients with known clinically significant acute unstable hepatic, renal, cardiovascular, or respiratory disease that will prevent participation in the study. 7.Patients with a history of alcohol, tobacco dependence, or any substance abuse. 8.Pregnant and lactating women or suspected to be pregnant. 9. Patients with known hypersensitivity to Ashwagandha. 10. Patients who had participated in other clinical trials during the previous 3 months. 11. Patients who have any clinical condition, according to the investigator, do not allow safe fulfilment of clinical trial protocol. 12. Participants having any chronic physical, haematological, hormonal, or psychiatric illness and history of substance dependence. 13.Participant taking any other herbal preparations containing Ginseng, Brahmi, Gingko Biloba or similar herbs will not be considered for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in score for Profile of Mood States (POMS, abbreviated version) questionnaire and Patient Reported Outcomes Measurement Information System (PROMIS-29) questionnaire from baseline.Timepoint: Baseline, Week 4, Week 8, Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in scores for Perceived Stress Scale (PSS) questionnaire from baseline.Timepoint: Baseline, Week 4, Week 8, Week12;Mean change in scores for Oxford Happiness Questionnaire (OHQ) questionnaire from baseline.Timepoint: Baseline, Week 4, Week 8, Week 12;• Mean change in scores for Pittsburgh Sleep Quality Index (PSQI) questionnaire from baseline.Timepoint: Baseline, Week 4, Week 8, Week 12;Mean change in stress hormone (Sr. cortisol) from baseline.Timepoint: Baseline, Week 12;Mean change in Liver (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, bilirubin) parameters from baseline.Timepoint: Baseline, Week 12;Mean change in Renal (serum creatinine, blood urea nitrogen) parameters from baseline.Timepoint: Baseline, Week 12;Number and proportion of Treatment-Emergent Adverse Events (TEAEs) over 8 weeks.Timepoint: Baseline, Week 4, Week 8, Week 12;Number and proportion of Treatment-Emergent Serious Adverse Events (TESAE) over 8 weeksTimepoint: Baseline, Week 4, Week 8, Week 12 | — |
Countries
India
Contacts
Public ContactDrRajesh Yashwant Patil
Gautami Nursing Home
Outcome results
None listed