Clinical comparison of the effects of Foeniculum vulgare fruit and medroxyprogesterone in treatment of abnormal uterine bleedings in patients with polycystic ovarian syndrome
The aim of this study is the comparison of clinical efficacy of fennel fruit and medroxyprogesterone in treatment of abnormal uterine bleedings in patients with polycystic ovarian syndrome. The study is randomized, not blinded, without a placebo control and in 1-2 trial phase. The main objective of study is treatment and from the type of intervention. The inclusion criteria include having polycystic ovary syndrome and menstrual disorders and the exclusion criteria is non-compliance to the plan. The number of patients is 66 that 33 patients receive fennel and 33 patients take medroxyprogesterone. The intervention period is 3 months and the primary outcomes of the study include oligomenorrhea, hypermenorrhea, menorrhagia, polymenorrhagia, menometrorrhagia, metrorrhagia and amenorrhea.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903013922N2
Registration date:2015-02-04, 1393/11/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-04, 1393/11/15
Registrant information
Name
Masoud Modarresi
Name of organization / entity
Faculty of Pharmacy - Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1835 6168
Email address
mmodarresi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2014-12-01, 1393/09/10
Expected recruitment end date
2015-12-01, 1394/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical comparison of the effects of Foeniculum vulgare fruit and medroxyprogesterone in treatment of abnormal uterine bleedings in patients with polycystic ovarian syndrome
Public title
The effect of fennel fruit in treatment of abnormal uterine bleedings caused by polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: polycystic ovarian syndrome; abnormal uterine bleeding. Exclusion criteria: non-compliance to the plan.
Age
From 20 years old to 45 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Building No. 2, Shaheed Beheshti Blv., Kermanshah
City
Kermanshah
Postal code
Approval date
2014-08-16, 1393/05/25
Ethics committee reference number
20359
Health conditions studied
1
Description of health condition studied
Polycystic Ovarian Syndrom
ICD-10 code
E28.2
ICD-10 code description
Sclerocystic ovary syndrome
Primary outcomes
1
Description
oligomenorrhea
Timepoint
the first day of the study, 90th day
Method of measurement
questionnaire
2
Description
hypermenorrhea
Timepoint
the first day of the study, 90th day
Method of measurement
questionnaire
3
Description
menorrhagia
Timepoint
the first day of the study, 90th day
Method of measurement
questionnaire
4
Description
polymenorrhagia
Timepoint
the first day of the study, 90th day
Method of measurement
questionnaire
5
Description
menometrorrhagia
Timepoint
the first day of the study, 90th day
Method of measurement
questionnaire
6
Description
metrorrhagia
Timepoint
the first day of the study, 90th day
Method of measurement
questionnaire
7
Description
amenorrhea
Timepoint
the first day of the study, 90th day
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, aqueous extract of fennel fruit (capsule form) is given orally, 600 mg twice in a day for three consecutive months.
Category
Treatment - Drugs
2
Description
In control group, medroxyprogesterone is given orally, 5 mg twice in a day for 10 consecutive days during three consecutive menstrual cycles.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Private Clinic of Gynecologist
Full name of responsible person
Dr. Nasrin Jalilian
Street address
Shafa Building, Shahrdari Parking, Kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Kermanshah University of Medical Sciences, Building No. 2, Shaheed Beheshti Blv., Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of medical Sciences, Faculty of Pharmacy
Full name of responsible person
Dr. Masoud Modarresi
Position
Member of the Scientific Board of the University / Asosiate Professor (Ph.D.)
Other areas of specialty/work
Street address
Faculty of Pharmacy, Parastar Blv., Dnashgah St., Shaheed Shiroodi Blv.
City
Kermanshah
Postal code
6734667149
Phone
+98 83 3427 6482
Fax
Email
mmodarresi@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of medical Sciences, Faculty of Pharmacy
Full name of responsible person
Dr. Masoud Modarresi
Position
Member of the Scientific Board of the University / Assistant Professor (Ph.D.)
Other areas of specialty/work
Street address
Faculty of Pharmacy, Parastar Blv., Dnashgah St., Shaheed Shiroodi Blv.
City
Kermanshah
Postal code
Phone
+98 83 3427 6482
Fax
Email
mmodarresi@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of medical Sciences, Faculty of Pharmacy
Full name of responsible person
Dr. Masoud Modarresi
Position
Member of the Scientific Board of the University / Asosiate Professor (Ph.D.)
Other areas of specialty/work
Street address
Faculty of Pharmacy, Parastar Blv., Dnashgah St., Shaheed Shiroodi Blv.
City
Kermanshah
Postal code
6734667149
Phone
+98 83 3427 6482
Fax
Email
mmodarresi@kums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)