The effect of propolis dietary supplement consumption on indices of high-sensitivity C-reactive protein, testosterone hormone and metabolic profile in women with polycystic ovary syndrome (PCOS)
The effect of propolis diet supplement on the status of the body's inflammatory index, testosterone and metabolic profile in women with polycystic ovary syndrome
Design
Randomized double-blind, control trial of phase 3 with parallel groups design of 56 patients. Table of random numbers is used for randomization.
Settings and conduct
We select 56 women with PCOS referring to the gynecologist clinic located in Shahid Beheshti Hospital in Isfahan and we will divide them into 2 groups receiving propolis supplement and placebo. For proper blindness, the drug and placebo will be exactly the same and none of the participants and researchers will be aware of them until the end of the study. At the beginning of the study and 12 weeks after the intervention, blood samples will be taken and the necessary measurements will done. During this period, participants are advised to eat a healthy diet and perform 30-45 minutes of physical activity daily.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Diagnosis of PCOS according to the Rotterdam criteria, Age between 18 and 45 years, Do not take any drug other than metformin
Criteria for not entering:
Hormone therapy or taking contraceptive pills, History of gestational hypertension, Pregnancy or breastfeeding, Tobacco and alcohol consumption, having certain diseases
Intervention groups
Intervention group: 2 tablets of 350 mg daily containing 250 mg of propolis extract before lunch and dinner, for 12 weeks.
Placebo group: 2 tablets of 350 mg placebo daily containing 350 mg microcrystalline cellulose before lunch and dinner for 12 weeks.
Main outcome variables
Fasting blood sugar; Insulin; HOMA-IR index; triglyceride; Cholesterol; High-density lipoprotein; Low-density lipoprotein; testosterone; High sensitivity C-reactive protein; Status of menstrual disorders; blood pressure; Height; Weight; Waist; Waist to hip ratio; BMI
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20121216011763N51
Registration date:2021-03-07, 1399/12/17
Registration timing:retrospective
Last update:2021-03-07, 1399/12/17
Update count:2
Registration date
2021-03-07, 1399/12/17
Registrant information
Name
Gholamreza Askari
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1792 2110
Email address
askari@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of propolis dietary supplement consumption on indices of high-sensitivity C-reactive protein, testosterone hormone and metabolic profile in women with polycystic ovary syndrome (PCOS)
Public title
The effect of propolis dietary supplement on the status of hs-CRP inflammatory index, sex hormone testosterone levels and metabolic profile of women with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of PCOS according to Rotterdam criterion: According to this criterion, the subjects should have two of the three diagnostic features of PCOS: 1- Oligomenorrhea and anovulation 2- Hyperandrogenism 3- Polycystic ovary
Age between 18 and 45 years
Not to have sensitivity to bee products
Not to take any specific drug more than metformin
Not to have laparoscopic ovarian surgery and assisted reproductive technology
Exclusion criteria:
Hormone therapy or taking contraceptive pills (OCP)
History of gestational hypertension
Pregnancy or breastfeeding
Menopause
Tobacco and alcohol consumption
Having following diseases: Diabetes, cardiovascular, hepatic, renal, thyroid, asthma, neoplasm
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be divided into intervention and control groups using block classified randomization. The following authoritative site will be used to allocate the intervention in the above-mentioned manner.
https://www.sealedenvelope.com/simple-randomiser/v1/lists
In this way, people are randomly divided into two groups of intervention and control using quadruple blocks based on age and sex.
It is noteworthy that participants and outcome assessors will not be aware of patient grouping and will be blind to it.
Blinding (investigator's opinion)
Double blinded
Blinding description
For proper blinding, the drug and placebo will be exactly the same in color, size, and odor, and none of the participants and researchers will be aware of them until the end of the study, except for the pharmacist.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jarib St., Isfahan University of Medical Sciences, School of Nutrition, Department of Community Nutrition, Dr. Gholamreza Askari
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-11-25, 1399/09/05
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.587
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
Homeostatic model assessment of insulin resistance (HOMA-IR)
Intervention group: Daily consumption of two 350 mg tablets containing 250 mg of propolis extract and 100 mg of safe and ineffective combination of microcrystalline cellulose as a supplemental formulation, made by Reyhan Naghsh Jahan Pharmaceutical Company, Isfahan before lunch and dinner for 12 weeks
Category
Treatment - Drugs
2
Description
Control group: Daily consumption of two 350 mg placebo tablets containing 350 mg of microcrystalline cellulose, made by Reyhan Naghsh Jahan Pharmaceutical Company, Isfahan before lunch and dinner for 12 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Dr. Hatav Ghasemi Tehrani
Street address
Metal Bridge, Ostad Motahhari St., Obstetrics and Gynecology Hospital, Shahid Beheshti Isfahan
City
Isfahan
Province
Isfehan
Postal code
5354181848
Phone
+98 31 3234 6338
Email
Hatav.tehrani2014@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Askari
Street address
Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3151
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Community Nutrition, Faculty of Nutrition, Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3171
Email
askari@mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Position
Ph.D of nutrition, Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Community Nutrition, Faculty of Nutrition, Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3171
Fax
Email
askari@mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elahe Abbasi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Community Nutrition, Faculty of Nutrition, Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 3171
Fax
Email
eabbasi97@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
Data can be shared after people are not identified.
When the data will become available and for how long
access 1 year after publishing results
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
The data will be available in order to know the details of the research and any secondary analysis of the data is allowed due to the permission of the project owner.
From where data/document is obtainable
Dr. Gholamreza Askari, Department of Community Nutrition, School of Nutrition, Isfahan University of Medical Sciences, Hezar Jarib St.
Askari@mui.ac.ir
What processes are involved for a request to access data/document
Submit your application via email to eabbasi97@yahoo.com if your application is approved, you will receive the documents within a maximum of 1 month.