Fenugreek and metformin with different mechanisms effect on the FBS and insulin. The objective of the study was to assessment of addetive effect of fenugreek seed on the insulin resistancy in infertile women with polycystic ovarian syndrom. This was a prospective randomized, double-blind, placebo-controlled trial. The study was conducted at the Montaserieh Hospital. The patient population was 58 that have inclusion criteria: infertility etiology of ovarian factor, normal function of liver and kidney, FBS<200mg/dl,.... Women were randomly allocated to intervention or control groups and were assessed before and every 4 weeks within a treatment period of 8 weeks. Patients in intervention group used feugreek capsuls of 500mg twice daily and metformin tablets of 500mg three times a day. Patients in control group used placebo capsuls twice daily and metformin tablets like intervention group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810082924N1
Registration date:2010-02-02, 1388/11/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-02-02, 1388/11/13
Registrant information
Name
Maryam Hassanzadeh Bashtian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3151 1206
Email address
m.h.bashtian@gmail.com
Recruitment status
Recruitment complete
Funding source
Mashhad university of medical sciences
Expected recruitment start date
2007-11-26, 1386/09/05
Expected recruitment end date
2009-01-08, 1387/10/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of addetive effect of Fenugreek seed extract on the insulin resistancy in infertile women with polycystic ovarian syndrom
Public title
Assessment of effect of Fenugreek seed on the insulin resistancy in the infertile women with polycystic ovarian
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. female infertility,2. To have two of three criteria for PCOS( oligo/amenorrhea, clinical sign or biochemical hyperandrogenism, PCOS in sonographic view), 3. insulin resistance (FGIR<4.5), 4. FBS<200mg/dl, 5. normal function of liver and kidney(Cr<1.4mg/dl), 6. selected for ovarian stimulation. Exclusion criteria: 1.diabetes mellitus type one, hyperprolactinemia, hypothyroidism, adrenal disorder, abnormal HSG, previous medical disease (septecemia, kidney failure, congestion heart failure, gastrointestinal disorder), confound drugs to the metformin.
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
58
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research of Mashhad University of medical sciences
Street address
Ghoreshi building, Daneshgah street
City
Mashhad
Postal code
Approval date
2007-08-17, 1386/05/26
Ethics committee reference number
85182
Health conditions studied
1
Description of health condition studied
Insulin resistance in infertile women with polycystic ovarian syndrome(PCOS)
ICD-10 code
N99
ICD-10 code description
Other disorders of genitourinary tract
Primary outcomes
1
Description
insulin resistance
Timepoint
End of 8 weeks
Method of measurement
Biochemical and hormonal tests
2
Description
fasting blood sugar (FBS)
Timepoint
End of 8 weeks
Method of measurement
Biochemical test
3
Description
golucose tolerance test of two hours (GTT)
Timepoint
End of 8 weeks
Method of measurement
Biochemical test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: hydroalcholic of fenugreek seeds extract capsuls and metformin tablet (Fenugreek capsuls of 500mg twice daily and metformin tablets of 500mg three times a day for 8 weeks)
Category
Treatment - Drugs
2
Description
Control group: placebo capsuls and metformin tablet(Placebo capsuls twice daily and metformin tablets of 500mg three times a day for 8 weeks)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Montaserieh hospital
Full name of responsible person
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Mashhad University of medical sciences
Full name of responsible person
Dr jalil Tavakol Afshari
Street address
Ghoreshi bulding - Daneshgah street
City
Mashhad
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 of Mashhad 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
Mashhad university of medical sciences
Full name of responsible person
Maryam Hassanzadeh Bashtian
Position
MSc in midwifery
Other areas of specialty/work
Street address
Sadaf street, Sadaf 2, No:64
City
Mashhad
Postal code
Phone
+98 51 1867 4826
Fax
Email
bashtian@yahoo.com; M.H.Bashtian@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad university of medical sciences
Full name of responsible person
Maryam Hassanzadeh Bashtian
Position
MSc in midwifery
Other areas of specialty/work
Street address
Sadaf street, Sadaf 2, No:64
City
Mashhad
Postal code
Phone
+98 51 1867 4826
Fax
Email
bashtian@yahoo.com; M.H.Bashtian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Maryam Hassanzadeh Bashtian
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)