Aim of this study assesses effect dill of anethum graveolens linn on improvement of sleep disorders due to premenstrual syndrome. This study is clinical trial and double blind. Inclusion criteria: age 15 to 45; premenstrual syndrome. Exclusion criteria: psychological disorder; digestive disorder; sleep disorder except for premenstrual syndrome; sedative drug. We will divide 142 patients in two groups’ intervention and control randomize by random numbers table. We will complete questionnaire for sleep disorder and flatulence in first and end of study. We will complete questionnaire for sleep disorder by pittsburgh sleep quality questionnaire. We will prescribe dill of anethum graveolens linn two dills in day (every 12 hours) duration fourteenth to twenty-fourth day of menstrual periods in intervention group. We will prescribe dill of placebo (wheat flour) two dills in day (every 12 hours) duration fourteenth to twenty-fourth day of menstrual periods in control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016120720258N19
Registration date:2017-01-06, 1395/10/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-01-06, 1395/10/17
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice President of Research Arak University of Medical Sciences
Expected recruitment start date
2015-12-06, 1394/09/15
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dill (anethum graveolens linn) on improvement of sleep disorders due to premenstrual syndrome
Public title
Effect of dill (anethum graveolens linn) on improvement of sleep disorders due to premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 15 to 45; premenstrual syndrome
Exclusion criteria: psychological disorder; digestive disorder; sleep disorder except for premenstrual syndrome; sedative drug
Age
From 15 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
142
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomize with random numbers table
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Arak University of Medical Sciences
Street address
Vice President of Research, Payambarazam Complex, Basij Square, Sardasht, Arak
City
Arak
Postal code
3814957558
Approval date
2015-11-23, 1394/09/02
Ethics committee reference number
IR.ARAKMU.REC.1394.214
Health conditions studied
1
Description of health condition studied
Premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Sleep disorder
Timepoint
Before and after intervention
Method of measurement
Pittsburgh sleep quality questionnaire
2
Description
Flatulence
Timepoint
Before and after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:We will prescribe dill of anethum graveolens linn two dills in day (every 12 hours) duration fourteenth to twenty-fourth day of menstrual periods .
Category
Treatment - Drugs
2
Description
Control group: We will prescribe dill of placebo (wheat flour) two dills in day (every 12 hours) duration fourteenth to twenty-fourth day of menstrual periods.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Taleghani hospital
Full name of responsible person
Dr Maryam Shokrpour
Street address
Emam khomeini, Taleghani hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research Arak University of Medical Sciences