(1) Objectives: To compare the effects of drugs on oligomenorrhea with Agnogol and metformin in patients with polycystic ovary syndrome (2) Design: The study in women with polycystic ovary syndrome in women with oligomenorrhea referred to feminin Fatemieh clinic ftatemiye hospital , with a sample content of 120 , randomized, double-blind clinical trial, single-center, Phase 2-3 clinical trial will be conducted. (3) How do the population of eligible women, will be the first visit by a gynecologist and then as an entry criteria, Randomized block permutation . The subjects were randomly assigned to two groups: A (group receiving drugAgnogoll) and group B (consumer groups metformin), or other groups taking medication Agnogol and consumer groups like metformin divided,Then for 3 periods are intervention by drugs .Check list before and after the intervention is completed by individuals. (4) inclusion criteria: (1) married; Not pregnant; There oligomenorrhea Exclusion criteria from the study: taking any medications that affect the menstrual cycle; Allergy medication; Taking oral contraceptives (5) interventions: medication Agnogol and metformin for 3 months in each group separately (6) The main outcome : Improve oligomenorrhea
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015072623350N1
Registration date:2015-09-08, 1394/06/17
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-09-08, 1394/06/17
Registrant information
Name
Arezoo Shayan
Name of organization / entity
Hamadan University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0551
Email address
a.shayan@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Hamadan University of Medical Sciences
Expected recruitment start date
2015-10-24, 1394/08/02
Expected recruitment end date
2016-03-21, 1395/01/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effect of the drug agnogol and metformin on oligomenorrhea in patients with polycystic ovary syndrome
Public title
The effect of agnogl on oligomenorrhea in polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: being married; Being pregnant; There oligomenorrhea; No known physical or mental illness confirmed by a psychiatrist; Not taking any hormonal medication to treat menstrual disorders in the last three months; No history of allergies to herbal medicines; No drugs affecting the menstrual cycle; Not taking anti-androgen drugs and combinations of estrogen and progesterone secretion and insulin action and insulin and drugs affecting between 1 month before the survey; No history of liver disease, kidney, cardiovascular, diabetes Exclusion criteria: taking any medications that affect the menstrual cycle; Allergy medication; Drugs and oral contraceptives; Androgen-secreting tumors, high blood prolactin; Unwillingness to cooperate in the project
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Method of randomization block permutation is a table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Boulevard Martyr Fahmideh, Hamadan University Of Medical Sciences, Hamadan
City
Hamadan
Postal code
Approval date
2015-07-25, 1394/05/03
Ethics committee reference number
IR.UMSHA.REC.1394.230
Health conditions studied
1
Description of health condition studied
Oligomenorrhea
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
Improve oligomenorrhea
Timepoint
Before, 3 months after intervention
Method of measurement
Check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:Agnogol drug contains extracts of five fingers prescription orally,3.2-4.8 mg 1 times daily After a meal, for 3 month
Category
Treatment - Drugs
2
Description
In intervention group2: Metformin prescription orally,500 mg 3 times daily ( totally 1500 mg), for 3 month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemiyeh Hospital
Full name of responsible person
Soghra Rabiee
Street address
Clinic Women, Fatemiyeh Hospital, Hamadan
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research, Hamadan University of Medical Sciences
Full name of responsible person
Mohammad Yosef Alikhani
Street address
Street Martyr Fahmideh, Hamadan University Of Medical Sciences , Hamadan
City
Hamadan
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, Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Arezoo.Shayan
Position
Masters, Lecturer Faculty
Other areas of specialty/work
Street address
Street Martyr Fahmideh, Hamadan University of Medical Sciences, Hamadan
City
Hamadan
Postal code
8617654783
Phone
+98 813838551
Fax
-
Email
arezoo.shayan2012@yahoo.com; a.shayan@sums.ac.ir
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Medical Science Hamadan
Full name of responsible person
Arezoo.Shayan
Position
Masters, Lecturer Faculty
Other areas of specialty/work
Street address
Street Martyr Fahmideh, Hamadan University Of Medical Science , Hamadan
City
Hamadan
Postal code
Phone
+98 813838551
Fax
Email
arezoo.shayan2012@yahoo.com; a. shayan@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
University Of Medical Sciences Hamadan
Full name of responsible person
Arezoo.Shayan
Position
Master degree, Lecturer faculty
Other areas of specialty/work
Street address
Street Martyr Fahmideh, Hamadan University of Medical Sciences , Hamadan
City
Hamadan
Postal code
8617654783
Phone
+98 38380551
Fax
-
Email
arezoo.shayan2012@yahoo.com; a.shayan@umsha.ac.ir
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)