Evalution of the effect of combination therapy with extract of Bunium Persicum and Foeniculum Vulgare on clinical features in Polycystic Ovary Syndrome (PCOS) patients
Determination of the effect of combination therapy with extract of Bunium Persicum and Foeniculum Vulgare on clinical features in Polycystic Ovary Syndrome (PCOS) patients
Design
In this study, 70 patients with PCOS with inclusion criteria are divided into two groups.control and intravention group, the control group receive only the routine treatment plus placebo , and the intervention group receive in addition to routine drugs, the combination with extract of Bunium Persicum and Foeniculum Vulgare twice daily. after four months the therapeutic effects of the capsule will be examined.
Inclusion criteria: Polycystic ovary syndrome
Exclusion criteria: History of drug use for PCOS; Ocp users; No regular use of herbal medicine
Intervention groups
Intervention group:receive the combination therapy with extract of Bunium Persicum and Foeniculum Vulgare for four months twice a day
Main outcome variables
Menstrual pattern
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120709010222N20
Registration date:2018-11-14, 1397/08/23
Registration timing:registered_while_recruiting
Last update:2018-11-14, 1397/08/23
Update count:0
Registration date
2018-11-14, 1397/08/23
Registrant information
Name
Zahra Keivani
Name of organization / entity
Shahrekord University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 38 1222 0016
Email address
keivani@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evalution of the effect of combination therapy with extract of Bunium Persicum and Foeniculum Vulgare on clinical features in Polycystic Ovary Syndrome (PCOS) patients
Public title
Evalution of the effect of combination therapy with extract of Bunium Persicum and Foeniculum Vulgare on clinical features in Polycystic Ovary Syndrome (PCOS) patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Polycystic ovary syndrome
Exclusion criteria:
History of drug use for PCOS
Ocp users
No regular use of herbal medicine
Age
From 16 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
70people who have been admitted to the study, who had been previously visited by the doctor, are divided into two groups of 35 members by randomly assigned random numbers.Blocked randomization is intended to ensure that exactly the same number of participants participates in consecutive but equal intervals, into three groups.The size of each block in this study is 35.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher and the patient will have no information about the content of the capsules
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Vice Chancellor of Research and Technology, Shahrekord University of Medical Sciences,Kashani Blvd, Shahrekord,Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2018-09-23, 1397/07/01
Ethics committee reference number
IR.SKUMS.REC.1397.162
Health conditions studied
1
Description of health condition studied
Pcos
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Menstrual pattern
Timepoint
every months
Method of measurement
checklist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In addition to routine drugs,receive the combination of extract of Bunium Persicum and Foeniculum Vulgare for four months twice a day.
Category
Treatment - Drugs
2
Description
Control group: In addition to routine drugs, they receive a placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Hospital
Full name of responsible person
Belgheyse Mohammadi
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
mohammadi.b@skums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Shahrekord University of Medical Sciences
Full name of responsible person
Belghese Mohammadi
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
City
shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
mohammadi.b@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of Shahrekord University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Belghese Mohammadi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
mohammadi.b@skums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Belghese Mohammadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
mohammadi.b@skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Belghese Mohammadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Kashani Hospital of Shahrekord University of Medical Sciences, Parastar street, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3222 0016
Email
mohammadi.b@skums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total data in article format
When the data will become available and for how long
1397
To whom data/document is available
researcher
Under which criteria data/document could be used
publication
From where data/document is obtainable
journals
What processes are involved for a request to access data/document