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
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
-
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.