The effect of royal jelly supplementation on hormonal status, insulin resistance and inflammatory factors in patients with polycystic ovary syndrome: pilot study
Determination of the effect of royal jelly supplementation on hormonal status,insulin resistance and inflammatory factors in patients with (PCOS)
Design
A parallel-group, triple-blind, randomized, phase 2 clinical trial in 24 patients. The rand function of Excel software was used for randomization.
Settings and conduct
This pilot study will be conducted on 24 women with (PCOS) in Imam Reza Hospital of TBZMED. The patients included in the study will be randomly divided into two groups receiving placebo and intervention receiving 1000 mg of royal jelly per day. The duration of the intervention will be 60 days, and the side effects of the supplement will be recorded by recording all clinical symptoms. Placebo capsules will be prepared and packaged in the form of the supplement. In this study, the researcher, the patient, the laboratory technician and the results analyst will be blinded to the study groups. Before and after the intervention, fasting blood will be taken from all patients and all blood biochemical factors including inflammatory indices, sex hormones, serum insulin and fasting blood sugar will be measured.
Participants/Inclusion and exclusion criteria
Entry criteria: Female volunteers aged 18-45 with clinical symptoms of hyperandrogenism. Exclusion criteria: Lack of consent to participate in the study, Pregnancy, breastfeeding, Suffering from diseases such as Autoimmune, Digestive, Liver, Thyroid and Unstable Cardiovascular diseases, severe respiratory disease, Taking any type of vitamin and mineral supplements in the last six months, people with a history of allergies
Intervention groups
Control group: Receive placebo medicine once a day for two months. Intervention group: They receive 100 mg royal jelly tablets daily for two months.
The effect of royal jelly supplementation on hormonal status, insulin resistance and inflammatory factors in patients with polycystic ovary syndrome: pilot study
Public title
The effect of royal jelly supplementation on hormonal status,insulin resistance and inflammatory factors in patients with polycystic ovary syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Female volunteers aged 18-45 with clinical symptoms of hyperandrogenism
Exclusion criteria:
Pregnancy
Breastfeeding
Having diseases such as autoimmune diseases
Digestive diseases
Liver disease
Thyroid
Unstable cardiovascular diseases
Severe respiratory disease (Asthma and Chronic bronchitis)
Taking any type of vitamin and mineral supplements in the last six months
People with a history of allergies
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Stratified permuted block randomization will be applied to stratify participants into different stratum and blocks based on probable confounders including age and BMI. Each block will be randomly allocated to the intervention or control groups. The sequence of the blocks will be prepared for each stratum Random Allocation Software (RAS). For each patient in a definite block, a matched person in terms of the aforementioned variables would be considered in that block. Participants and investigators will be blind to the trial group assignments until the end of the study and data analysis.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo capsules will be prepared and packaged as well as the supplement form. Coding of packages containing supplements and placebos will be done by someone other than the researchers as A, B, and volunteers will be randomly assigned to placebo and intervention groups. In this study, the researcher, the patient, the laboratory technician and the results analyst will be blind to the study groups (triple blind).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Tabriz University of Medical Sciences
Street address
Ethics Committee,Tabriz University of Medical Sciences, Golgasht Street , Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2022-12-04, 1401/09/13
Ethics committee reference number
IR.TBZMED.REC.1401.808
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
Estrogen
Timepoint
Baseline and 2 months after the treatment
Method of measurement
ELISA Test
2
Description
Testosterone
Timepoint
Baseline and 2 months after the treatment
Method of measurement
ELISA Test
3
Description
Sex Hormone-Binding Globulin (SHBG)
Timepoint
Baseline and 2 months after the treatment
Method of measurement
ELISA Test
4
Description
Fasting blood sugar
Timepoint
Baseline and 2 months after the treatment
Method of measurement
Electrochemiluminescence Test
5
Description
Insulin resistance with HOMA-IR score
Timepoint
Baseline and 2 months after the treatment
Method of measurement
Electrochemiluminescence Test
6
Description
Interleukin 6
Timepoint
Baseline and 2 months after the treatment
Method of measurement
Electrochemiluminescence Test
7
Description
hs-CRP
Timepoint
Baseline and 2 months after the treatment
Method of measurement
Electrochemiluminescence Test
8
Description
Body mass scale
Timepoint
Baseline and 2 months after the treatment
Method of measurement
Weight scale and stadiometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: will receive Royal jelly capsule (1000 mg) once a day manufactured by STP pharma factory for 2 months.
Category
Treatment - Drugs
2
Description
Control group: The placebo capsule filled with starch is completely similar to the used supplement and is taken once a day for two months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Imam Reza Hospital
Full name of responsible person
Dr.Majid Mobasseri
Street address
Department of Endocrinology, Imam Reza Hospital, Daneshgah Square, Tabriz, East Azarbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 8939
Email
mobasserim@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Vice chancellor for Research,Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
70751
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
dr.Majid Mobasseri
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology and Metabolism
Street address
Department of Endocrinology, Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 8939
Email
Mobasserim@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Majid Mobasseri
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology and Metabolism
Street address
Department of Endocrinology, Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 8939
Email
mobasserim@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Majid Mobasseri
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Endocrinology and Metabolism
Street address
Department of Endocrinology, Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 41 3334 8939
Email
mobasserim@tbzmed.ac.ir
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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
Access starting 6 months after publication
To whom data/document is available
The data will only be available for people working in academic institutions.
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers, for conducting Meta-analysis.
From where data/document is obtainable
The researchers (student and her supervisor)
What processes are involved for a request to access data/document
After the publication of the article, the researchers should have access to the study documents through an email request from the person in charge of the project (mobasserim@tbzmed.ac.ir).