1. Home
  2. Approved trials
  3. » فارسی

Investigating the effect of Lycium barbarum polysaccharide on oxidative stress indicators and sperm health in patients with varicocele - a double-blind validated clinical trial study

Protocol summary

Study aim
Investigating the protective and antioxidant effect of (Lycium barbarum) on sperm health and function in patients with varicocele.
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 2 on 80 patients. The rand function of Excel software was used for randomization.
Settings and conduct
In this clinical trial study, which will be conducte in the infertility center of Afzalipur Hospital in Kerman, 80 volunteers with type 2 varicocele were divided into two groups of 40 people, including the control group that will receive placebo and the treated group that They will receive 400 mg of polysaccharide extract (lycium barbarum) daily for two months, then after 90 days of taking the last dose, blood and semen samples will be taken to measure the serum activity of superoxide dismutase, glutathione peroxidase and malonase Dialdehyde enzymes. and testosterone hormone and sperm health parameters will be measured microscopically and macroscopically.
Participants/Inclusion and exclusion criteria
Eligibility conditions: Type 2 varicocele - Age range 18 to 65 - No varicocelectomy Conditions for not entering the study: suffering from any secondary disease - taking any anti-inflammatory and corticosteroid drugs and strengthening drugs and supplements - occurrence and suffering from any food allergy
Intervention groups
first group: 40 patients with type 2 varicocele who receive placebo for 60 days second group: 40 patients with type 2 varicocele who receive 400 mg of Lycium barbarum polysaccharide for 60 days.
Main outcome variables
Determining the average enzyme activity of superoxide dismutase, glutathione peroxidase, malondialdehyde, testosterone, sperm count, motility, morphology and semen volume in patients with varicocele under the administration of 400 mg Lycium barbarum polysaccharide and the control group under placebo administration.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210415050978N1
Registration date: 2023-03-18, 1401/12/27
Registration timing: retrospective

Last update: 2023-03-18, 1401/12/27
Update count: 0
Registration date
2023-03-18, 1401/12/27
Registrant information
Name
maryam mehdikhanloo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8804 7316
Email address
maryam.m.khanloo@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-26, 1401/04/05
Expected recruitment end date
2022-07-19, 1401/04/28
Actual recruitment start date
2022-06-26, 1401/04/05
Actual recruitment end date
2022-07-19, 1401/04/28
Trial completion date
2022-07-19, 1401/04/28
Scientific title
Investigating the effect of Lycium barbarum polysaccharide on oxidative stress indicators and sperm health in patients with varicocele - a double-blind validated clinical trial study
Public title
Investigating the effect of Lycium barbarum polysaccharide on oxidative stress indicators and sperm health in patients with varicocele - a double-blind validated clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having varicocele grade two
Exclusion criteria:
No history of varicocelectomy
Age
From 18 years old to 65 years old
Gender
Male
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 80
Actual sample size reached: 80
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we are going to collect 80 patients with type 2 varicocele and referred to the infertility center of Afzalipur Hospital in Kerman, and we will use a random number for each case, and then a different color of labels for each group. Install on the files
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, participating patients do not know what group they are in and whether they will receive placebo or medicine. Also, the main researcher himself is not aware of this process, in line with that, the doctor and personnel participating in the project located in Afzalipur Hospital, as well as the statistical consultant and statistical analyst participating in the project have been blinded.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Rafsanjan university of medical sciense, Pesteh Blvd, KHalije fars Blvd, City: Rafsanjan
City
Rafsanjan
Province
Kerman
Postal code
37718175911
Approval date
2022-04-13, 1401/01/24
Ethics committee reference number
IR.RUMS.REC.1401.014

Health conditions studied

1

Description of health condition studied
Grade 2 varicocele
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Percentage of people with grade two varicocele
Timepoint
Day 0 and 90 days after receiving the last dose of the drug
Method of measurement
Diagnosis by doctor and spermogram

Secondary outcomes

empty

Intervention groups

1

Description
Control group: Patients with grade 2 varicocele receiving daily placebo for 60 days
Category
Placebo

2

Description
Intervention group: Patients with grade two varicocele, prescribed with Lycium barbarum at a daily dose of 400 mg for 60 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility Center of Afzalipur Hospital
Full name of responsible person
maryam mehdikhanloo
Street address
Afzalipur Medical Education Center, near Shahid bahonar university, Imam Khomeini Highway
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Fax
Email
maryam.m.khanloo@gmail.com
Web page address
http://ah.kmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
mohammadreza haji zadeh
Street address
Central Organization, Imam Ali Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
info@rums.ac.ir
Web page address
https://rums.ac.ir/#anchor8
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
maryam mehdikhanloo
Position
Master student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
No2, Dead end Nastaran, Majid pour Ave, Vanak Sq
City
Tehran
Province
East Azarbaijan
Postal code
1993919781
Phone
+98 21 8804 7316
Email
maryam.m.khanloo@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
maryam mehdikhanloo
Position
master student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
No2, Dead end Nastaran, Majid pour Ave, Vanak Sq
City
Tehran
Province
Tehran
Postal code
1993919781
Phone
+98 21 8804 7316
Email
maryam.m.khanloo@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
maryam mehdikhanloo
Position
master student
Latest degree
Master
Other areas of specialty/work
Biochemistry
Street address
No2, Dead end Nastaran, Majid pour Ave, Vanak Sq
City
Tehran
Province
Tehran
Postal code
1993919781
Phone
+98 21 8804 7316
Email
maryam.mkhanloo@gmail.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
Due to the presence of personal information such as addiction, failed fertility, registration of past diseases
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
No - There is not 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
No - There is not a plan to make this available
Loading...