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Investigating the Effect of Royal Jelly on the expression of Some Members of S100, Apoptosis, Inflammasomes and Chemokines Families in the Patients with Chronic HBV Infections

Protocol summary

Study aim
Determining the effect of oral administration of Royal Jelly on the gene expression of S100A10, S100A9, S100A4, MANGO, OCTB4, BAX, NLRP1, NLRP3, ASC, CCL2, CCL3 and CCL8 molecules
Design
Clinical trial containing the patients who infected with Hepatitis B virus of both sexes in the age range of 20 to 60 years in the period from August to December 2021, double-blind, randomized and phase 1 on 50 patients. The oral administration period of Royal Jelly is one month .
Settings and conduct
Patients with Hepatitis B referred to Kerman Medical Sciences Hospital will be under the supervision of a specialist and will complete the consent form before entering the study. Before receiving Royal Jelly, 5 ml of blood sample will be taken. Each patient will then receive one gram of Royal Jelly orally daily for one month. After one month, blood samples are taken from each patient again. On all blood samples before and after oral administration of Royal Jelly, the expression of the gene expression of S100A10, S100A9, S100A4, MANGO, OCTB4, BAX, NLRP1, NLRP3, ASC, CCL2, CCL3 and CCL8 molecules will be evaluated using the SYBR Green based real-time PCR assay before receiving Royal Jelly. The researcher will measure the above cases in relation to the blind study.
Participants/Inclusion and exclusion criteria
Infected with Hepatitis B
Intervention groups
50 Hepatitis B virus infected patients will be treated with oral administration of royal jelly at a rate of one gram per day for a month. Royal jelly will be used as an intervention agent. Before and after oral administration of Royal Jelly, the gene expression of some immune molecules will be examined using the SYBR Green based real-time PCR assay . The results will be compared before and after oral administration of Royal Jelly in infected patients.
Main outcome variables
Gene expression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210620051640N1
Registration date: 2021-08-26, 1400/06/04
Registration timing: prospective

Last update: 2021-08-26, 1400/06/04
Update count: 0
Registration date
2021-08-26, 1400/06/04
Registrant information
Name
Morteza Bahaaldin-Beygi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3347 8017
Email address
beygi_morteza@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-10, 1400/06/19
Expected recruitment end date
2022-03-10, 1400/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Effect of Royal Jelly on the expression of Some Members of S100, Apoptosis, Inflammasomes and Chemokines Families in the Patients with Chronic HBV Infections
Public title
The Effect of Royal Jelly on Gene Expression of Some Immune Factors in People Infected with Hepatitis B
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Infected with Hepatitis B for more than six months
Exclusion criteria:
Infected by other viruses Suffering from immune related diseases Receiving drugs that affect the immune system
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
More than 1 sample in each individual
Number of samples in each individual: 2
Five ml of blood before and after receiving Royal Jelly orally
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The sample tests will be analyzed by blind review
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Islamic Azad University,Kerman Branch(Biomedical Research Ethics Commitee)
Street address
Valiasr Ave,
City
Kerman
Province
Kerman
Postal code
7635131167
Approval date
2021-05-12, 1400/02/22
Ethics committee reference number
IR.IAU.Kerman.REC.1400.010

Health conditions studied

1

Description of health condition studied
Hepatitis B
ICD-10 code
B18
ICD-10 code description
Chronic viral hepatitis

Primary outcomes

1

Description
Gene expression of some molecules of S100 families, apoptosis, inflammation and chemokines is measured in patients with hepatitis B before and after oral administration of Royal Jelly.
Timepoint
Before and after taking Royal Jelly orally
Method of measurement
Real time PCR assay

Secondary outcomes

empty

Intervention groups

1

Description
In this study, 50 Hepatitis B virus infected patients will be treated with oral administration of royal jelly at a rate of one gram per day for a month. Royal jelly will be used as an intervention agent. Royal jelly will be prepared from beekeepers in Iran. Before and after oral administration of Royal Jelly, the gene expression of some molecules of the S100 family, apoptosis, inflammation, and chemokines will be examined using the SYBR Green based real-time PCR assay too. The results will be compared before and after oral administration of Royal Jelly.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Kerman Special Disease hospital
Full name of responsible person
Morteza Bahaadin Beygi
Street address
Valiasr Ave,
City
Kerman
Province
Kerman
Postal code
7635131167
Phone
+98 34 3132 1376
Fax
+98 34 3321 2893
Email
beygi_morteza@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ashraf Kariminik
Street address
Valiasr Ave,
City
Kerman
Province
Kerman
Postal code
7635131167
Phone
+98 34 3132 1376
Fax
+98 34 3321 1405
Email
akarimish@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University, Kerman Branch
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Morteza Bahaadin Beygi
Position
Ph.D. Student
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Valiasr Ave,
City
Kerman
Province
Kerman
Postal code
7635131167
Phone
+98 34 3132 1376
Email
beygi_morteza@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Morteza Bahaadin Beygi
Position
Ph.D. Student
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Valiasr Ave,
City
Kerman
Province
Kerman
Postal code
7635131167
Phone
+98 34 3132 1376
Email
beygi_morteza@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Morteza Bahaadin Beygi
Position
Ph.D. student
Latest degree
Master
Other areas of specialty/work
Microbiology
Street address
Valiasr Ave,
City
Kerman
Province
Kerman
Postal code
7635131167
Phone
+98 34 3132 1376
Fax
+98 34 3321 1405
Email
beygi_morteza@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
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