Comparison of the efficacy of herbal medicine (Mixture) with Clomiphene citrate in treatment of Poly-cystic ovary syndrome (PCOS) and fertility rate in infertile women referring toTabriz Al-Zahra hospital.
The aim of study is to evaluate the effects of herbal medicine (Mixture) on Polycystic ovary syndrome (PCOS) in infertile women. herbal medicine (Mixture) is a 700 mg capsule containing 250 mg Mentha longifolia, 200 mg Zingiber officinale, 150 mg Cinnamon and 100 mg Citrus that is standardized by Part Teb International Company. 102 patients diagnosed with PCOS and infertility and aged 20-35 after obtaining inform consent will be randomly selected and assigned to 3 groups; 34 people in each. Random assignment of individuals to each group would allow confounding factors to be well controlled. In case of drug intolerance or dissatisfaction in any stage of the study, they are free to withdraw any time. The first group (intervention) will be given herbal medicine (Mixture) with a dose of 700mgs/day continuous for 3 months, the second group (control) will receive routine treatment of Clomiphene Citrate 50-150 mg for 3 menstrual cycles, starting from 5th day of menstruation for 5 days and the third group (intervention) will receive both herbal medicine (Mixture) and routine treatment as mentioned above. Before intervention and three months after the completion of medication patients in all three groups will be evaluated by blood tests of sex hormones (FSH, LH, estradiol, testosterone), biochemical markers (glucose, cholesterol, triglycerides, insulin), antioxidants levels (catalase, glutathione peroxidase, superoxide peroxidase, malondialdehyde) and Sonographic criteria of the ovary (ovarian size, number and size of follicles). This study is not blinded. In this study, improvement of ovarian cysts is considered as the primary outcome and pregnancy as secondary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201509295563N7
Registration date:2016-01-09, 1394/10/19
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-01-09, 1394/10/19
Registrant information
Name
Elaheh Ouladsahebmadarek
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1554 1221
Email address
madarek@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research,Tabriz University Of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of herbal medicine (Mixture) with Clomiphene citrate in treatment of Poly-cystic ovary syndrome (PCOS) and fertility rate in infertile women referring toTabriz Al-Zahra hospital.
Public title
Evaluation of the effects of herbal medicine (Mixture) on Polycystic ovary syndrome (PCOS) in infertile women.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Clinical Androgen ( Ferriman-Gallwey score greater than 8) or biochemical androgen (testosterone, free / total); Amenorrhea (menstrual cycle is less than 9-6 times per year) or anovulation; polycystic ovaries on ultrasound (the number of antral follicles in one ovary is less than 12 so that the volume is lesser than 10 cm3)
Exclusion criteria: in case of drug intolerance or dissatisfaction in any stage of the study, 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:
102
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
Golgasht Street, Tabriz University Of Medical Sciences
City
Tabriz
Postal code
Approval date
2015-10-03, 1394/07/11
Ethics committee reference number
TBZMED.REC.1394.576
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Treatment of ovarian cysts
Timepoint
Before the intervention, three months after intervention
Method of measurement
Ultrasound of the ovaries (ovarian size, number and size of follicles)
Secondary outcomes
1
Description
Pregnancy
Timepoint
3 months after taking medicinal plants (Citro Plus)
Method of measurement
Positive BhcG
Intervention groups
1
Description
" :Intervention group: " herbal medicine (Mixture) 700 mgs/day continuous for 3 cycles.
Category
Treatment - Drugs
2
Description
"Control group" Clomiphene Citrate 50-150 mg for 3 cycles
Category
Treatment - Drugs
3
Description
'' :Intervention group: " herbal medicine (Mixture) 700 mgs/day continuous with Clomiphene Citrate 50-150 mg for 3 cycles.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Infertility Center Of Alzahra Hospital
Full name of responsible person
Dr.Elaheh Ouladsahebmadarek
Street address
Alzahra Hospital, South Artesh Ave
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
Woman's Reproductive Health Research Center
Full name of responsible person
Dr.arash khaki
Position
Prof. of Pathology
Other areas of specialty/work
Street address
Alzahra Hospital, South Artesh Ave
City
Tabriz
Postal code
Phone
+98 41 3556 9543
Fax
Email
arashkaki@yahoo.com; wrhrcenter@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
Dr.Elaheh Ouladsahebmadarek
Position
Prof. of Ob & Gyn
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences,Golgasht Street,
City
Tabriz
Postal code
Phone
+98 41 3556 9543
Fax
Email
Ainehchi.nava@gmail.com; wrhrcenter@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
Dr.Elaheh Ouladsahebmadarek
Position
Prof. of Ob & Gyn
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences,Golgasht Street,
City
Tabriz
Postal code
Phone
+98 41 3556 9543
Fax
Email
Ainehchi.nava@gmail.com; wrhrcenter@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)