The effect of 8 weeks of Royal Jelly supplementation and cache training on cardiac injury indices and oxidative stress in opium addicts quitting methadone
Determining the effect of 8 weeks of Royal Jelly supplementation and cache training on heart damage and oxidative stress indices in opium addicts quitting methadone
Design
A controlled clinical trial with a parallel-group design of 80 Subjects, Randomized by simple randomization method, Phase 2; on 80 patients
Settings and conduct
In this quasi-experimental study, referring to Naji Zahedan Addiction Treatment Center, 80 subjects are selected and divided into four groups. Blood samples are taken from patients 48 hours before the start and after the implementation of the training protocol.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Man
Type of addiction: Opium
Exclusion criteria: No heart disease , Not participating in sports in the last year
Intervention groups
Intervention group 1 : For eight weeks, Royal Jelly was consumed daily as an oral gel at a dose of 100 mg per kilogram of body weight. Intervention group 2 : Exercise with Cache : Subjects performed resistance exercises using Traband for 8 weeks and 3 consecutive sessions per week for 60 minutes each session.Intervention group 3 : Exercise with royal jelly supplements Subjects performed resistance exercises using Traband for 8 weeks and 3 consecutive sessions per week for 60 minutes each session. Royal jelly was also consumed daily as a oral gel at a dose of 100 mg per kilogram of body weight.Control group: No intervention, only follow up
Main outcome variables
Malondialdehyde
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170510033909N13
Registration date:2022-01-29, 1400/11/09
Registration timing:retrospective
Last update:2022-01-29, 1400/11/09
Update count:0
Registration date
2022-01-29, 1400/11/09
Registrant information
Name
فرزانه تقیان
Name of organization / entity
دانشگاه آزاد اسلامی.واحد اصفهان
Country
Iran (Islamic Republic of)
Phone
+98 913 308 0241
Email address
f.taghian@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2021-12-31, 1400/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of 8 weeks of Royal Jelly supplementation and cache training on cardiac injury indices and oxidative stress in opium addicts quitting methadone
Public title
The effect of supplementation and exercise on indicators of heart damage and oxidative stress in individuals Addicted
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Gender
Type of addiction: Opium
Age range 25 to 45 years
Exclusion criteria:
No heart disease
Not participating in sports in the last year
Age
From 25 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization;
Randomization Tool: Random Number Table;
Randomization Unit: Individual;
In order to use a table of random numbers, the researcher will first determine the reading position of the table numbers.
The numbers will then be considered for different groups. For example, zero to twenty-four for intervention A, twenty-five to forty-nine for intervention B, fifty to seventy-four for group C, and seventy-five to nine for group D.
Then we will touch one of the numbers and move in one of the predetermined directions. The numbers will be recorded and assigned to four groups: Exercise with cache, use Royal Jelly, combination and control.
In order to hide random allocation, the method of coded boxes with random sequence will be used. This method uses a number of boxes that are numbered randomly. Adequate sealing of the boxes, their apparent similarity and their weight will be ensured
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee on Research Islamic Azad University - Isfahan Branch (Khorasgan)
Street address
University Blvd, Arghavanie, East Gay Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8155139998
Approval date
2019-02-24, 1397/12/05
Ethics committee reference number
IR.ZAUMS.REC.1397.458
Health conditions studied
1
Description of health condition studied
Addicted
ICD-10 code
F19.20
ICD-10 code description
Other psychoactive substance dependence, uncomplicated
Primary outcomes
1
Description
Malondialdehyde
Timepoint
At the beginning and end of 8 weeks of study
Method of measurement
Serum concentration of CGRP by ELISA method using the Cayman Chemical Monobind USA
Secondary outcomes
1
Description
Superoxide dismutase
Timepoint
At the beginning and end of 8 weeks of study
Method of measurement
Serum concentration of superoxide dismutase is measured by ELISA method using Ransell kit made by Randox company.
Intervention groups
1
Description
Intervention group 1 : For eight weeks, Royal Jelly was consumed daily as an oral gel at a dose of 100 mg per kilogram of body weight.
Category
N/A
2
Description
Intervention group 2 : Exercise with Cache : Subjects performed resistance exercises using Traband for 8 weeks and 3 consecutive sessions per week for 60 minutes each session. Each workout included 10 minutes of warm-up, 40 minutes of core training, and 10 minutes of cooling
Category
Rehabilitation
3
Description
Intervention group 3 : Exercise with royal jelly supplements Subjects performed resistance exercises using Traband for 8 weeks and 3 consecutive sessions per week for 60 minutes each session. Royal jelly was also consumed daily as a oral gel at a dose of 100 mg per kilogram of body weight.
Category
Rehabilitation
4
Description
Control group: No intervention, only follow up
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Zahedan Naji Addiction Treatment Center
Full name of responsible person
Mohsen Khosravi
Street address
Facing the grain office,lmam Khomeini street,Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813913777
Phone
+98 54 3351 3777
Email
Baharanhospital@zaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Isfahan Branch (Khorasgan), Research Deputy
Full name of responsible person
Majid Toghyani
Street address
Khorasgan University, Arghavanie St, Isfaha
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3500 2352
Email
F_taghian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Isfahan Branch (Khorasgan), Research Deputy
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
Islamic Azad University
Full name of responsible person
Farzaneh Taghian
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University, Arghavanie St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8183895183
Phone
+98 31335002352
Email
F_taghian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzaneh Taghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University, Arghavanie St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8183895153
Phone
+98 81 8389 5183
Email
F_taghian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farzaneh Taghian
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Khorasgan University , Arghavanie St, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3500 2352
Email
F_taghian@yahoo.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