Anxiety Mental and Behavioural Disorders Anxiety
Conditions
Interventions
Herb: withania somnifera and multivitamin vs placebo
Sponsors
The Canadian College of Naturopathic Medicine (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females aged 18-65 that are Canada Post employees and members of Canadian Union of Postal Workers (CUPW). 2. Mentally competent subjects able to adhere to the given protocol and treatments administered as interventions. 3. Self-selected candidates identifying themselves to suffer from the symptoms of stress and anxiety for a period of 6 weeks or more and a score of at least 10 on the Beck Anxiety Inventory (BAI) at the pre-study intake. 4. Normal on physical examination at the pre-study intake, and in the case of abnormalities the medical practitioner considers them to be clinically insignificant. 5. Written and informed consent. 6. The potential candidate must have a family doctor that they have seen in the last 12 months. 7. A negative pregnancy test for menstruating women and a willingness to practice adequate birth control for the duration of the trial
Exclusion criteria
Exclusion criteria: 1. Mentally or physically incapacitated such that informed consent cannot be obtained. 2. Any history or other condition which the study physician regards as clinically significant to the study (including allergies or sensitivities to withanolides or multivitamins, gastritis or peptic ulcer). 3. A major illness considered to be clinically significant by the study physician within 3 months of the study start date. 4. Current participation in another intervention trial. 5. Pregnancy or intent to become pregnant in the next 6 months. 6. Medication at doses that is contraindicated with herb/multi-vitamin. (specifically daily use of benzodiazepene class drugs.) 7. Current alcoholism or substance abuse (sedative) 8. Current history of tumors. 9. Any current serious disorders determined to be clinically significant to the study. 10. Scoring above 20 on the Beck Depression Inventory. 11. Breast feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Beck Anxiety Inventory 2. Fatique Questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. SF-36 Questionnaire 2. Weight 3. Body Mass Index (BMI) | — |
Countries
Canada
Outcome results
None listed