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ISRCTN
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ISRCTN78958974
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ClinicalTrials.gov identifier
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Public title
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Effect of Naturopathic Treatments On Anxiety Outcomes of Postal Workers, a randomized controlled parallel group study
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Scientific title
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Acronym
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ENTOAOPW
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Serial number at source
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02
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Study hypothesis
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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.
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Ethics approval
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The research ethics board of the Canadian College of Naturopathic Medicine, approved on 12 September 2005
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Study design
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Randomised controlled parallel group study
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Anxiety
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2006
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Anticipated end date
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30/08/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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86
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Interventions
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Herb: withania somnifera and multivitamin vs placebo
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Primary outcome measure(s)
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1. Beck Anxiety Inventory
2. Fatique Questionnaire
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Secondary outcome measure(s)
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1. SF-36 Questionnaire
2. Weight
3. Body Mass Index (BMI)
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Sources of funding
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1. Canada Post Corporation (Canada)
2. The Canadian College of Naturopathic Medicine (Canada)
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19718255
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Contact name
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Dr
Orest
Szczurko
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Address
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353 Thrace Ave
Mississauga
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City/town
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Ontario
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Zip/Postcode
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L5B 2B2
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Country
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Canada
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Sponsor
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The Canadian College of Naturopathic Medicine (Canada)
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Address
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1255 Sheppard Ave E
Toronto
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City/town
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Ontario
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Zip/Postcode
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M2K 1E2
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Country
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Canada
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Date applied
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15/02/2007
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Last edited
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03/09/2009
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Date ISRCTN assigned
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28/03/2007
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