Effect of Naturopathic Treatments On Anxiety Outcomes of Postal Workers, a randomized controlled parallel group study
| ISRCTN | ISRCTN78958974 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78958974 |
| Secondary identifying numbers | 02 |
- Submission date
- 15/02/2007
- Registration date
- 28/03/2007
- Last edited
- 03/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Orest Szczurko
Scientific
Scientific
353 Thrace Ave
Mississauga
Ontario
L5B 2B2
Canada
Study information
| Study design | Randomised controlled parallel group study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ENTOAOPW |
| Study objectives | We hypothesise that a treatment utilizing withania somnifera and a multi vitamin along with encouragement to exercise and cognitive behavioral threapy will be more effective than encouragement to exercise and cognitive behavioral therapy plus placebo. |
| Ethics approval(s) | The research ethics board of the Canadian College of Naturopathic Medicine, approved on 12 September 2005 |
| Health condition(s) or problem(s) studied | Anxiety |
| Intervention | Herb: withania somnifera and multivitamin vs placebo |
| Intervention type | Supplement |
| Primary outcome measure | 1. Beck Anxiety Inventory 2. Fatique Questionnaire |
| Secondary outcome measures | 1. SF-36 Questionnaire 2. Weight 3. Body Mass Index (BMI) |
| Overall study start date | 01/01/2006 |
| Completion date | 30/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 86 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 30/08/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
353 Thrace Ave
Ontario
L5B 2B2
Canada
L5B 2B2
Canada
Sponsor information
The Canadian College of Naturopathic Medicine (Canada)
University/education
University/education
1255 Sheppard Ave E
Toronto
Ontario
M2K 1E2
Canada
"ROR" |
https://ror.org/03pjwtr87 |
|---|
Funders
Funder type
Industry
Canada Post Corporation (Canada)
No information available
The Canadian College of Naturopathic Medicine (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 31/08/2009 | Yes | No |
