Premenstrual syndrome is a mental, physical and behavioral problem in the reproductive women, and it occurs late of menstrual cycle before or at the onset of menstruation. About 10% of women during the reproductive years are severe premenstrual syndrome that affects the quality of life. Recent favorable treatment is herbal medicine. The purpose of this study is to determine the therapeutic effects of herbal medicine capsules of peppermint oil (Colpermin) on women with premenstrual syndromes. The study protocol is conducted on 60 women (15-20 years old) with a diagnosis of premenstrual syndrome. Premenstrual symptom is measured using Delany’s checklist 28 items during the luteal phase. The minimum and maximum score is between 0 and 84. The women are categorized into two group according the premenstrual syndrome uses cutoff scoring; scores of equal to or less than 15 as no premenstrual syndrome and greater than 15 as premenstrual syndrome. The women with premenstrual syndrome are randomly allocated to oral treatment with Peppermint Oil Capsule (Colpermin) 187 mg or placebo BID for 10 days (from15 to beginning menstruation) for two cycle (months). After the treatment, the participants will complete the questionnaires again. The women will participate in the study after an informed written consent.
General information
Acronym
Peppermint Oil Capsule (Colpermin)
IRCT registration information
IRCT registration number:IRCT2016020926446N2
Registration date:2016-03-23, 1395/01/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-23, 1395/01/04
Registrant information
Name
Mouloud Agajani Delavar
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 0714
Email address
m.aghajani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences, Reproductive and Infertility Research Center
Expected recruitment start date
2016-03-01, 1394/12/11
Expected recruitment end date
2016-10-01, 1395/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Treatment Effect of Peppermint Oil Capsule (Colpermin) for Premenstrual Syndrome
Public title
Premenstrual Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
15-20 years old; mentally healthy; with no history of mental illness; ability to understand the questionnaire; regular menstrual cycles (21-35 days); no history of surgery and death of their relatives within the last 6 months; not taking antidepressants or anti-anxiety during last 3 months; no history of allergy to peppermint and its derivatives; a minimum score of 16 on the basis of Delany’s checklist 28 items is be determined.
Age
From 15 years old to 20 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Ganj Afroz Ave, Babole University of Medical Sciences
City
Babo
Postal code
Approval date
2014-06-01, 1393/03/11
Ethics committee reference number
2244
Health conditions studied
1
Description of health condition studied
Premenstrual Syndrom
ICD-10 code
R10.3
ICD-10 code description
Pain localized to other parts of lower abdomen
Primary outcomes
1
Description
mental symptoms
Timepoint
after 2 month end of consum of drugs
Method of measurement
Delany’s checklist
2
Description
behavioral symptoms
Timepoint
after 2 month end of consum of drugs
Method of measurement
Delany’s checklist
3
Description
Physical symptoms
Timepoint
after 2 month end of consum of drugs
Method of measurement
Delany’s checklist
Secondary outcomes
1
Description
Side effects of drugs such as complaints of heart bourn
Timepoint
end of treatment
Method of measurement
questionnaire
2
Description
Side effects of drugs such as complaints of allergic
Timepoint
end of treatment
Method of measurement
questionnaire
3
Description
Side effects of drugs such as complaints of hot flash
Timepoint
end of treatment
Method of measurement
questionnaire
4
Description
Side effects of drugs such as complaints of headaches
Timepoint
end of treatment
Method of measurement
questionnaire
5
Description
Side effects of mouth ulcer
Timepoint
end of treatment
Method of measurement
questionnaire
Intervention groups
1
Description
Peppermint Oil Capsule (Colpermin)187 mg BID for 10 days (from15 to beginning menstruation) for two cycle
Category
Treatment - Drugs
2
Description
placebo (the same colpermin), BID for 10 days from15 to beginning menstruation for two cycle
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol High School
Full name of responsible person
Mouloud Agajani Delavar
Street address
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Ali Bijani
Street address
Gan Afroz Ave, Babol University of Medical Sciences, Babol, Iran
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mouloud Agajani Delavar
Position
PhD.
Other areas of specialty/work
Street address
Ganj Afroz Ave, Babol University of Medical Sciences, Babol, Iran
City
Babol
Postal code
47176-47745
Phone
+98 11 3236 0714
Fax
Email
moloodaghajani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mouloud Agajani Delavar
Position
PhD.
Other areas of specialty/work
Street address
Gan Afroz Ave, Babol University of Medical Sciences, Babol, Iran
City
Babol
Postal code
Phone
+98 11 3236 0714
Fax
Email
m.aghajani@mubabol.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Mouloud Agajani Delavar
Position
PhD.
Other areas of specialty/work
Street address
Gan Afroz Ave, Babol University of Medical Sciences, Babol, Iran
City
Babol
Postal code
47176-47745
Phone
+98 11 3236 0714
Fax
+98 11 3236 0714
Email
m.aghajani@mubabol.ac.ir moloodaghajani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)