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The comparative study of effect of aerial parts of Stachys lavandulifolia and Medroxyprogestrone drug in symptomatic treatment of polycystic ovarian syndrome

Protocol summary

Summary
To compare the effect of aerial parts of Stachys lavandulifolia and Medroxyprogestrone drug in symptomatic treatment of polycystic ovarian syndrome in a randomised single blind clinical trial. Inclusion criteria: 1- with polycystic ovary syndrome 2- with abnormal uterine bleeding 3- sonographic appearance. Exclusion criteria: 1- lack of cooperation. Sample: 66 patients with polycystic ovary syndrome (33 in herbal drug group and 33 in chemical drug group) primary outcomes: 1- Abnormal uterine bleeding 2- sonographic appearance.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903013922N1
Registration date: 2010-05-22, 1389/03/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2010-05-22, 1389/03/01
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 Midical Sciences
Expected recruitment start date
2010-05-22, 1389/03/01
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparative study of effect of aerial parts of Stachys lavandulifolia and Medroxyprogestrone drug in symptomatic treatment of polycystic ovarian syndrome
Public title
The comparative study of effect of aerial parts of Stachys lavandulifolia and Medroxyprogestrone drug in symptomatic treatment of polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- with polycystic ovarian syndrome 2- with abnormal uterine bleeding 3- sonographic appearance. Exclusion criteria: 1- lack of cooperation.
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Faculty of Pharmacy - Kermanshah University of Medical Sciences
Street address
Parastar Blv.- Dnashgah St.- Shaheed Shiroodi Blv.
City
Kermanshah
Postal code
Approval date
empty
Ethics committee reference number
5136/420/7/پ

Health conditions studied

1

Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome

Primary outcomes

1

Description
ovarian cysts
Timepoint
3 month
Method of measurement
sonographic survey

2

Description
mensturation bleeding disorder
Timepoint
3 month
Method of measurement
questionnaire

Secondary outcomes

1

Description
side effects
Timepoint
3 month
Method of measurement
questionnaire

Intervention groups

1

Description
5g of Stachys lavandulifolia as infusion three time a day for 3 month
Category
Treatment - Drugs

2

Description
10mg of Medroxyprogestron per day for 10 days in a menstruation cycle for 3 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 Bul.- Shahrdari Parking
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of medical Sciences
Full name of responsible person
Masoud Modarresi
Street address
Research Deputy office, No. 2 Build. of Kermanshah University of medical Sciences, Shaheed Beheshti Blv.
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
Faculty of Pharmacy - Kermanshah University of medical Sciences
Full name of responsible person
Dr. Masoud Modarreri
Position
Faculty Member, Pharmacognosy Group Manager
Other areas of specialty/work
Street address
Faculty of Pharmacy, Parastar Blv., Dnashgah St., Shaheed Shiroodi Blv.
City
Kermanshah
Postal code
Phone
+98 83 1427 6482
Fax
Email
mmodarresi@kums.ac.ir , modarresi1262@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Pharmacy - Kermanshah University of medical Sciences
Full name of responsible person
Dr. Masoud Modarresi
Position
Pharm. D.- Pharmacognosy 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 1427 6482
Fax
Email
mmodarresi@kums.ac.ir , modarresi1262@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Leyla Ghaderi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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