This triple-blind randomized clinical trial will be conducted to assess the effect of Royal jelly on premenstrual symptoms. The study population comprise 110 female students who live in Tehran University of Medical Sciences dorms, having premenstrual symptoms according to premenstrual profile 2005 and satisfied the inclusion criteria such as no allergy to products of honey and not using any kind of treatment that influence the premenstrual syndrome. The participants will be randomly assigned into Royal jelly or placebo group. The participants in the intervention group will receive royal jelly capsule while participants in the control group will receive placebo with the same dosage. The outcome measures in this study are premenstrual symptoms, as obtained through the premenstrual profile 2005 before and during the intervention. At the end of the study, two premenstrual syndrome sign scores will be obtained for every participant (1 before intervention to recognize the eligible samples and 1, after 2 cycle intervention).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107192172N12
Registration date:2011-12-10, 1390/09/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-10, 1390/09/19
Registrant information
Name
Simin Taavoni
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 8161
Email address
staavoni@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tehran University of Medical Sciences and Research Institute for Islamic & Complementary Medicine
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2012-01-21, 1390/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of oral Royal jelly on severity of premenstrual syndrome in students living in Tehran medical university dorms
Public title
Effect of oral Royal jelly on severity of premenstrual syndrome
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age between 20 and 35 years old; not taking any medicine; having symptoms in 2 past cycles; not taking any complements; no allergy to honey or Royal jelly; no changes in diet & exercise program; not smoking, alcohol or drug usage
Exclusion criteria: use of any kind of drug or therapy for symptom relief during the study intervention; side effects during intervention for example allergy; change in diet or physical exercise program during the study; any kind of crisis in participant or her family; not taking royale jelly or placebo more than 7 days in 2 cycles
Age
From 20 years old to 35 years old
Gender
Female
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Department
Street address
No 23, Dameshgh St., Valiasr Ave
City
Tehran
Postal code
Approval date
2011-12-03, 1390/09/12
Ethics committee reference number
14628
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
Premenstrual syndrome (screening)
Timepoint
2 menstrual cycles
Method of measurement
premenstural profile 2005 scale
Secondary outcomes
1
Description
Premenstrual syndrome (prevention)
Timepoint
during intervention for 2 cycles
Method of measurement
premenstrual profile 2005 scale
Intervention groups
1
Description
Oral administration of 1000 mg Royal jelly capsule for 2 menstrual cycle