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A comparison between clinical, metabolic and endocrine effects of n-acetylcystein and metformin in women with poly cystic ovarian syndrome(PCOS).

Protocol summary

Summary
Objectives: A comparison between clinical, metabolic and endocrine effects of n-acetylcystein and metformin in women with poly cystic ovarian syndrome (PCOS). Design: Double blind randomized clinical trial. Setting and conduct: The patients will randomly assign into the two groups and will receive treatment for 24 weeks. Participants: Women with poly cystic ovarian syndrome Inclusion criteria: 20-36 years old, having poly cystic ovarian syndrome; (Rotterdam society criteria : 2 of 3; having 2 out of 3 criteria including oligo or anovulation, hyperandrogenemia or hyperandrogenism, poly cystic ovaries in ultrasound). Exclusion criteria: known other systemic and metabolic disorders, congenital adrenal hyperplasia, Cushing syndrome, androgen producing tumors, hyperprolactinemia, hypo or hyper thyroidism, diabetes mellitus, history of peptic ulcer, and any other drug use. Intervention: In one group n-acetylcystein and in the other group metformin will prescribe for 24 weeks. Main outcome: Change in menstrual cycle, weight, body mass index, fasting blood sugar, serum insulin, low density lipoprotein, HOMA index and high density lipoprotein.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201405082624N15
Registration date: 2014-05-29, 1393/03/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-05-29, 1393/03/08
Registrant information
Name
Maryam Kashanian
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7752 3487
Email address
maryamka@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator.
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2015-03-16, 1393/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison between clinical, metabolic and endocrine effects of n-acetylcystein and metformin in women with poly cystic ovarian syndrome(PCOS).
Public title
Treatment of poly cystic ovarian syndrome.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 20-36 years old; having poly cystic ovarian syndrome; (Rotterdam society criteria : 2 of 3; having 2 out of 3 criteria including oligo or anovulation, hyperandrogenemia, or hyperandrogenism, poly cystic ovaries in ultrasound). Exclusion criteria: known other systemic and metabolic disorders; congenital adrenal hyperplasia; Cushing syndrome; androgen producing tumors; hyperprolactinemia; hypo or hyper thyroidism; diabetes mellitus; history of peptic ulcer; any other drug use.
Age
From 20 years old to 36 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic comittee of Tehran University of Medical Sciences
Street address
Keshavarz Boulvard, Ghods Cross.
City
Tehran
Postal code
16117
Approval date
2014-01-26, 1392/11/06
Ethics committee reference number
92/د/130/ 2492

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
change in the menstrual cycle.
Timepoint
Monthly
Method of measurement
Data sheets

Secondary outcomes

1

Description
change in weight.
Timepoint
24 weeks
Method of measurement
data sheets

2

Description
change in body mass index.
Timepoint
24 weeks
Method of measurement
data sheets

3

Description
fasting blood sugar
Timepoint
24 weeks
Method of measurement
data sheets

4

Description
Serum insulin
Timepoint
24 weeks
Method of measurement
data sheets

5

Description
change in low density lipoprotein
Timepoint
24 weeks
Method of measurement
data sheets

6

Description
change in HOMA index.
Timepoint
24 weeks
Method of measurement
data sheets

7

Description
change in high density lipoprotein
Timepoint
24 weeks
Method of measurement
data sheets

Intervention groups

1

Description
N- acetylcystein prescription orally, 600 mg 3 times daily ( totally 1800 mg), for 24 weeks.
Category
Treatment - Drugs

2

Description
Metformin prescription orally,500 mg 3 times daily ( totally 1500 mg), for 24 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Akbarabadi Teaching Hospital
Full name of responsible person
Maryam Kashanian
Street address
Molavi avenue, Molavi Cross.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research ,Iran University of Medical Sciences.
Full name of responsible person
Dr Seyed Javad Mousavi
Street address
Hemmat High way, Chamran Cross.
City
Tehran
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 ,Iran 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
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor.
Other areas of specialty/work
Street address
No 9, Mostaghimi Alley, Khajeh Nasir Toosi Avenue, postcode 16117, Tehran, Iran.
City
Tehran
Postal code
16117
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
MD.
Other areas of specialty/work
Street address
Molavi avenue, Molavi Cross.
City
Tehran
Postal code
16117
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam Kashanian
Position
Professor
Other areas of specialty/work
Street address
Molavi Avenue, Molavi Cross.
City
Tehran
Postal code
16117
Phone
+98 21 5563 3244
Fax
Email
maryamkashanian@yahoo.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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