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A televised, web-based randomised trial of an herbal remedy (valerian) for insomnia
ISRCTN ISRCTN72748991
DOI 10.1186/ISRCTN72748991
ClinicalTrials.gov identifier
EudraCT number
Public title A televised, web-based randomised trial of an herbal remedy (valerian) for insomnia
Scientific title
Acronym SøvnStudien
Serial number at source 2005001TVT
Study hypothesis The primary objective is to evaluate whether valerian root (valerian) improves the self-assessed quality of sleep compared with placebo for people with primary insomnia
Lay summary
Ethics approval Regional Committee for Medical Research Ethics for Southern Norway (Regional komité for medisinsk forskningsetikk, Sør- Norge) 5 January 2006, Ref: S-05280
Study design Randomised, double-blind, parallel group, placebo controlled trial
Countries of recruitment Norway
Disease/condition/study domain Primary insomnia
Participants - inclusion criteria 1. Aged 18 –75 years, both inclusive
2. Insomnia lasting more than one month
3. Pittsburgh Sleep Quality Index (PSQI) score of > 5
4. Provide name of primary physician
5. Access to internet and own email address
6. At least 10 days of the sleep diary completed prior to randomisation
Participants - exclusion criteria 1. Secondary insomnia
2. Use of hypnotics by prescription
3. Depression
4. Alcohol or drug abuse
5. Psychotherapy within the past six months
6. Sleep apnoea, periodic limb movements disorder or restless legs syndrome
7. Pregnant or lactating women or women of childbearing potential who do not use an approved method of contraception (oral contraceptives orIntrauterine device [IUD])
8. Shift workers
9. History of hypersensitivity to valerian or its constituents
10. Participant rating of ‘usually’ or ‘always’ to the following questions in the Global Sleep Assessment Questionnaire:
During the past four weeks, how often:
a. Did you hold your breath, have breathing pauses, or stop breathing in your sleep?
b. Did you have restless or "crawling" feelings in your legs at night that went away if you moved your legs?
c. Did you have repeated rhythmic leg jerks or leg twitches during your sleep?
d. Did you have nightmares, or did you scream, walk, punch, or kick in your sleep?
e. Did any of the following disturb you in your sleep:
f. Pain?
g. Other physical symptoms?
h. Medications?
i. Did you snore loudly?
11. Current participation in another trial using an investigational compound
Anticipated start date 29/01/2007
Anticipated end date 30/03/2007
Status of trial Completed
Patient information material
Target number of participants 500 to 550
Interventions Coated Valerian Forte tablets 200 mg extract per tablet, corresponding to 1200 mg Valeriana officinalis. 3 tablets to be taken every night for 14 days

Information about the study will be televised nationally on a weekly health program. Viewers interested in participation will be invited to visit the web pages of the study to enrol. Participant registration and data collection will be by use of Internet.
Primary outcome measure(s) Proportion of participants in each group with an improvement in self-assessed quality of sleep of > or = 0.5 units between the average score for the 2 weeks before and 2 weeks during treatment
Secondary outcome measure(s) 1. Proportion of participants in each group with an improvement of > or = 0.5 units between the average score for the 2 weeks before and 2 weeks during treatment for each of the four variables:
1.1 Sleep latency
1.2 Number of awakenings
1.3 Total sleep time
1.4 Energy level during the day

2. Mean changes in the five outcomes listed above

3. Global self-assessment

If a difference is not found between the treatment groups for the primary and secondary variables, the following explorative variables will be analysed:
1. Proportion of participants in each group with any improvement in mean difference (i.e. all score changes > 0) between the average score for the 2 weeks before and 2 weeks during treatment for each of the five variables:
1.1 Quality of sleep
1.2 Sleep latency
1.3 Number of awakenings
1.4 Total sleep time
1.5 Energy level during the day

2. Difference in the profile of the five endpoints during the intervention period taking into account the baseline period, including a potential time effect
Sources of funding Norwegian Knowledge Centre for the Health Services (Norway)
Trial website http://sovnstudien.forskningspuls.no/
Publications Results on http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17940604
Contact name Dr  Andrew David  Oxman
  Address Norwegian Knowledge Centre for the Health Services
P.O. Box 7004
St. Olavs plass
  City/town Oslo
  Zip/Postcode N-0130
  Country Norway
  Email oxman@online.no
Sponsor Norwegian Knowledge Centre for the Health Services (Norway)
  Address P.O. Box 7004
St. Olavs plass
  City/town Oslo
  Zip/Postcode N-0130
  Country Norway
  Email post@kunnskapssenteret.no
  Sponsor website: http://www.kunnskapssenteret.no
Date applied 22/01/2007
Last edited 25/10/2007
Date ISRCTN assigned 01/03/2007
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