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Effect of Naturopathic Treatments On Anxiety Outcomes of Postal Workers, a randomized controlled parallel group study
ISRCTN ISRCTN78958974
DOI 10.1186/ISRCTN78958974
ClinicalTrials.gov identifier
EudraCT number
Public title Effect of Naturopathic Treatments On Anxiety Outcomes of Postal Workers, a randomized controlled parallel group study
Scientific title
Acronym ENTOAOPW
Serial number at source 02
Study hypothesis 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.
Lay summary
Ethics approval The research ethics board of the Canadian College of Naturopathic Medicine, approved on 12 September 2005
Study design Randomised controlled parallel group study
Countries of recruitment Canada
Disease/condition/study domain Anxiety
Participants - 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
Participants - 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
Anticipated start date 01/01/2006
Anticipated end date 30/08/2006
Status of trial Completed
Patient information material
Target number of participants 86
Interventions Herb: withania somnifera and multivitamin vs placebo
Primary outcome measure(s) 1. Beck Anxiety Inventory
2. Fatique Questionnaire
Secondary outcome measure(s) 1. SF-36 Questionnaire
2. Weight
3. Body Mass Index (BMI)
Sources of funding 1. Canada Post Corporation (Canada)
2. The Canadian College of Naturopathic Medicine (Canada)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19718255
Contact name Dr  Orest   Szczurko
  Address 353 Thrace Ave
Mississauga
  City/town Ontario
  Zip/Postcode L5B 2B2
  Country Canada
Sponsor The Canadian College of Naturopathic Medicine (Canada)
  Address 1255 Sheppard Ave E
Toronto
  City/town Ontario
  Zip/Postcode M2K 1E2
  Country Canada
Date applied 15/02/2007
Last edited 03/09/2009
Date ISRCTN assigned 28/03/2007
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