Efficacy and Safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult
This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women with High Stress and Anxiety. All eligible subjects who meet the Inclusion and Exclus
| Condition(s) | Stress, Anxiety |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of a Proprietary Blend of Ashwagandha Root Extract (Aqueous) in Adult Men and Women with High Stress and Anxiety. All eligible subjects who meet the Inclusion and Exclusion criteria will be part of the study. Subjects will be informed about the purpose of the study and signed informed consent will be taken. Subjects will be randomized to either one of the three treatment arms. Subjects will then be asked to either take one capsule containing the proprietary blend of Ashwagandha root extract or Ashwagandha root extract or Placebo orally twice daily with a glass of water for 8 weeks. The primary objective is to compare the efficacy of a propri |
| Who can participate | 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. Hamilton Anxiety Rating Scale (HAM-A) total score between 14 and 30 at the screening/randomization visit. 4. Perceived Stress Scale (PSS) score ≥13 at the screening/randomization visit. 5. BMI between 20 and 35. 6. No plan to commence new treatments over the study period. 7. 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 are permissible. 8. Must have the ability and willingness to sign an i |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | SF Research Institute, Inc. |
| Locations | San Francisco, California, United States |
| Start date | 2024-10-25 |
| NCT ID | NCT06714942 |
| Official listing | https://clinicaltrials.gov/study/NCT06714942 |