Protocol summary

Summary
The aim of study is evaluation of the effects of herbal medicine (Mixture) on Polycystic ovary syndrome (PCOS) in females 60 patients aged 20-35 that are not willing to fertility or single women due to menstrual disorders or hirsutism and acne referred to Al-Zahra infertility health reseach center. In case of the diagnosis of polycystic ovary syndrome the consent form will taken and include to study. In case of drug intolerance or dissatisfaction in any stage of the study and body mass index above 30, they are free to withdraw any time. In this study, patients randomly will divided into 2 groups, 30 persons in each. Control group: will received an oral contraceptives for 3 menstrual cycles from the 5th day of menstruation for a period of 21 days. Intervention group: an oral contraceptives per day with continouos treatment of 700mgs herbal medicine per day for 3 months. Method of Preparation of Herbal Medicine 700mg: Cinnamon, Ginger, Orange peel and Mentha longifolia will purchased from natural habitats and reputable sources and then washed and dried thenPune 250 mg + ginger 200 mg + cinnamon150 mg and 100 mg of orange peel will grounded and mixed together and each empty capsule will filled with this mixture and will administered to intervention population. The adjustions of dose will done by pharmacognosist. Before treatment, the consent form will taken from the subjects and for FSH, LH, estradiol, cholesterol, triglycerides, LDL, HDL, testosterone, FBS, insulin, sonography to evaluate the dimension,size and number of follicles in the ovaries and fill up the questionnaire that contain questions regarding clinical signs of PCO such as; status of menstrual cycle, hirsutism,acne and period of infertility. After 3 and 6 months of treatment, the study population will again subjected to a repeat sonography and tests. Eliminating or reducing the clinical symptoms of hirsutism and acne and regular menstrual cycle will be reviewed as a consequence of the initial plan. The study is not blinded.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201609015942N4
Registration date: 2016-10-02, 1395/07/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-10-02, 1395/07/11
Registrant information
Name
Aliye Ghasemzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3553 9160
Email address
gasemzadeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor For Research, Tabriz University Of Medical Sciences
Expected recruitment start date
2016-09-27, 1395/07/06
Expected recruitment end date
2017-09-28, 1396/07/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of herbal medicine (Mixture) ‍on Polycystic ovary syndrome (PCOS) in women and girls with PCOS sign and symptom
Public title
Evaluation of the effects of herbal medicine (Mixture) ‍on Polycystic ovary syndrome (PCOS) in women and girls with PCOS sign and symptom
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: In case of the diagnosis of polycystic ovary syndrome the consent form will taken and include to study Exclusion criteria: In case of drug intolerance or dissatisfaction in any stage of the study and body mass index above 30; they are free to withdraw any time.
Age
From 20 years old to 35 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
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
Ethics Committee Of Tabriz University Of Medical Sciences.
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Postal code
Approval date
2016-08-27, 1395/06/06
Ethics committee reference number
IR.TBZMED.REC.1395.538

Health conditions studied

1

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

Primary outcomes

1

Description
Clinical symptoms of hirsutism
Timepoint
3 and 6 months after treatment
Method of measurement
Ultrasound and tests

2

Description
Clinical symptoms of acene
Timepoint
3 and 6 months after treatment
Method of measurement
Ultrasound and tests

Secondary outcomes

empty

Intervention groups

1

Description
Control group: will received an oral contraceptives for 3 menstrual cycles from the 5th day of menstruation for a period of 21 days.
Category
Treatment - Drugs

2

Description
Intervention group: an oral contraceptives per day with continuous treatment of 700mgs herbal medicine per day for 3 months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Aliye Ghasemzadeh
Street address
Alzahra Hospital, South Artesh St.,Tabriz, iran
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for Research,Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Alireza Rashidi
Street address
Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for Research,Tabriz 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
Tabriz University Of Medical Sciences
Full name of responsible person
Aliye Ghasemzadeh
Position
Associate Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Aliye Ghasemzadeh
Position
Associate Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Aliye Ghasemzadeh
Position
Associate Professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences Tabriz , Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.com
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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