Evaluation of Iranian Traditional medicine-based diet on anthropometric and metabolic factors
Design
Randomized controlled Clinical trial on 74 women with PCOs
Settings and conduct
Patients with PCOS are referred to the women's clinic of Taleghani Hospital which meets the inclusion criteria. After obtaining written consent, they will enter the study, then during 8 weeks, they will be randomly divided into the group receiving lifestyle modification recommendations and diet based on traditional medicine and the group receiving lifestyle modification recommendations. At the beginning and end of the study Anthropometric indicators of patients are measured and blood tests are also performed. Visiting and consulting patients is done separately and on different days
Participants/Inclusion and exclusion criteria
Women aged 28 to 42 with polycystic ovary syndrome, with a body mass index of 25 and above, who do not have diabetes, do not take hormonal and insulin regulatory drugs, do not have thyroid hormone disorders, hyperprolactinemia, and adrenal disorders.
Intervention groups
37 women with PCOs receive diet and recommendations for lifestyle modification
37 women with PCOs receive recommendations for lifestyle modification
Main outcome variables
FBS, insulin, HOMA, VAI, lipid profile, BMI, WHR
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230627058594N1
Registration date:2023-09-01, 1402/06/10
Registration timing:prospective
Last update:2023-09-01, 1402/06/10
Update count:0
Registration date
2023-09-01, 1402/06/10
Registrant information
Name
Parivash Gholami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
dr.p.qolami@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Metabolic Effects of Iranian Medicine-Based Diet in Women with Polycystic Ovarian Syndrome
Public title
Effect of Diet in Polycystic Ovarian Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with polycystic ovarian syndrome
Body mass index>= 25
The population of eligible women will be randomly assigned and placed in two groups of 37, A and B, using a random block permutation design.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, after obtaining consent, eligible individuals are randomly placed in one of two intervention or control groups. In the control group, after the necessary explanations, a sheet containing lifestyle modification recommendations in 15 paragraphs is given to the individual. In the intervention group, in addition to the advice sheet for lifestyle modification, a sheet including a diet based on Iranian traditional medicine is also provided
Placebo
Not used
Assignment
Parallel
Other design features
This study offers traditional-available foods for lifestyle modification and improvement of women with polycystic ovarian syndrome
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti Univercity of Medical Science
Street address
Shahid Beheshti Univercity of Medical Science, Sh. Arab Ave. Yaman Ave., Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.SBMU.RETECH.REC.1402.115
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
Body mass index
Timepoint
Before intervention and 2 months later
Method of measurement
Calculation
2
Description
Waist circumference
Timepoint
Before intervention and 2 months later
Method of measurement
Tape measuring
3
Description
Hip circumference
Timepoint
Before intervention and 2 months later
Method of measurement
Tape measuring
4
Description
FBS
Timepoint
Before intervention and 2 months later
Method of measurement
Enzymatic method
5
Description
Triglyceride
Timepoint
Before intervention and 2 months later
Method of measurement
Enzymatic method
6
Description
Serum HDL
Timepoint
Before intervention and 2 months later
Method of measurement
Enzymatic method
7
Description
Insulin
Timepoint
Before intervention and 2 months later
Method of measurement
Eliza
8
Description
FBS/fasting Insulin
Timepoint
Before intervention and 2 months later
Method of measurement
Calculation
9
Description
Visceral adiposity index
Timepoint
Before intervention and 2 months later
Method of measurement
Calculation
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: for 8 weeks, an Iranian traditional medicine-based diet is provided along with recommendations for lifestyle modification, and to follow the program, a telephone connection is made every 2 weeks.
Category
Lifestyle
2
Description
Control group: They receive lifestyle modification recommendations for 8 weeks
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Talegani hospital
Full name of responsible person
Parivash Gholami
Street address
Taleghani hospital, Velenjac, Shahid Chamran highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 2558
Fax
+98 21 2243 2600
Email
taleghanihospital@sbmu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
7th floor, Bldg No.2 SBUMS, Arabi Ave, Velenjak, Tehran Shahid Beheshti Univercity of Medical Sciences. No. 8. Shams Alley. In front of Tavanir Ave., Vali-Asr Ave
City
Tehran
Province
Tehran
Postal code
6941119839
Phone
+98 21 2243 9781
Fax
Email
Mpajouhesh@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parivash Gholami
Position
PhD Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Shahid Beheshti Univercity of Medical Sciences. No. 8. Shams Alley. In front of Tavanir Ave., Vali-Asr Ave
City
تهران
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
dr.p.qolami@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parivash Gholami
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Shahid Beheshti Univercity of Medical Sciences. No. 8. Shams Alley. In front of Tavanir Ave., Vali-Asr Ave
City
تهران
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
dr.p.qolami@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Parivash Gholami
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Shahid Beheshti Univercity of Medical Sciences. No. 8. Shams Alley. In front of Tavanir Ave., Vali-Asr Ave
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
dr.p.qolami@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available