Condition category
Mental and Behavioural Disorders
Date applied
15/02/2007
Date assigned
28/03/2007
Last edited
03/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Orest Szczurko

ORCID ID

Contact details

353 Thrace Ave
Mississauga
Ontario
L5B 2B2
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

02

Study information

Scientific title

Acronym

ENTOAOPW

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Anxiety

Intervention

Herb: withania somnifera and multivitamin vs placebo

Intervention type

Supplement

Phase

Not Specified

Drug names

withania somnifera and a multi vitamin

Primary outcome measures

1. Beck Anxiety Inventory
2. Fatique Questionnaire

Secondary outcome measures

1. SF-36 Questionnaire
2. Weight
3. Body Mass Index (BMI)

Overall trial start date

01/01/2006

Overall trial end date

30/08/2006

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

86

Participant 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

Recruitment start date

01/01/2006

Recruitment end date

30/08/2006

Locations

Countries of recruitment

Canada

Trial participating centre

353 Thrace Ave
Ontario
L5B 2B2
Canada

Sponsor information

Organisation

The Canadian College of Naturopathic Medicine (Canada)

Sponsor details

1255 Sheppard Ave E
Toronto
Ontario
M2K 1E2
Canada

Sponsor type

University/education

Website

Funders

Funder type

Industry

Funder name

Canada Post Corporation (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Canadian College of Naturopathic Medicine (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19718255

Publication citations

  1. Results

    Cooley K, Szczurko O, Perri D, Mills EJ, Bernhardt B, Zhou Q, Seely D, Naturopathic care for anxiety: a randomized controlled trial ISRCTN78958974., PLoS ONE, 2009, 4, 8, e6628, doi: 10.1371/journal.pone.0006628.

Additional files

Editorial Notes