Investigating the effect of hydroalcoholic extract of purslane plant compared to placebo on the level of cardiac biomarkers in dialysis patients: a double-blind clinical trial study
Determining the effect of hydroalcoholic extract of purslane plant on heart biomarkers of dialysis patients
Design
Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 88 patients, using an online site for random assignment.
Settings and conduct
This study will be conducted in Yasuj city. Considering that all the patients covered by Yasuj University of Medical Sciences are 88, all of them will be included in the study as available and will be divided into two groups by random block allocation. The study will be double-blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age at least 30 years; dialysis for at least 3 months and at least twice a week.
Exclusion criteria:
Presence of active malignancy, presence of uncontrolled infection
Intervention groups
For the intervention group, 500 mg of purslane plant will be given in capsule form twice a day for 4 weeks. The control group will be given a placebo in addition to the standard treatment during the intervention period.
Investigating the effect of hydroalcoholic extract of purslane plant compared to placebo on the level of cardiac biomarkers in dialysis patients: a double-blind clinical trial study
Public title
The effect of purslane on the heart of dialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Dialysis for at least 3 months
Perform dialysis at least 2 times a week
Exclusion criteria:
Presence of active malignancy
Uncontrolled active infection
Age
From 30 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, all dialysis patients of Yasuj city will be included if they meet the inclusion criteria. Then they will be divided into two intervention and control groups through random blocks. Groups will be divided into A and B codes. Group A will be considered intervention and group B will be considered as control. Random allocation will be done by https://www.sealedenvelope.com. Each of the qualified people is assigned to one of the groups according to the created list. Blocks of different sizes (2, 4, 6, and 8) will be created to avoid the risk of predictable allocation of individuals to different groups. Blocks of doubles would be AB, blocks of four would be ABAB, blocks of six would be AABABB, and blocks of eight would be ABBABABA.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, to ensure that the participants and the researcher are not aware of the allocation of groups, a placebo with the same shape, color, smell and taste as purslane hydroalcoholic extract will be used. The packaging of the active supplement and the placebo is coded and the same, and only one independent person who has no role in the process of conducting the study maintains the codes. Participants are randomly assigned to intervention and control groups, and the medicine is distributed by a nurse who is not aware of their contents. Until the end of the study, researchers and participants will be unaware of the type of intervention they received.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Shahid Motahari
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2024-12-25, 1403/10/05
Ethics committee reference number
IR.YUMS.REC.1403.131
Health conditions studied
1
Description of health condition studied
نارسایی مزمن کلیوی
ICD-10 code
N18.4
ICD-10 code description
Chronic kidney disease, stage 4 (severe)
Primary outcomes
1
Description
Alanine Aminotransferase
Timepoint
Before and Immediately After the Intervention
Method of measurement
Laboratory Kit
2
Description
Aspartate Aminotransferase
Timepoint
Before and Immediately After the Intervention
Method of measurement
Laboratory Kit
3
Description
Creatine Kinase
Timepoint
Before and Immediately After the Intervention
Method of measurement
Laboratory Kit
4
Description
Lactate Dehydrogenase
Timepoint
Before and Immediately After the Intervention
Method of measurement
Laboratory Kit
5
Description
Pro- Brain Natriuretic Peptide
Timepoint
Before and Immediately After the Intervention
Method of measurement
Laboratory Kit
6
Description
Blood Urea Nitrogen
Timepoint
Before and Immediately After the Intervention
Method of measurement
Laboratory Kit
7
Description
Creatinine
Timepoint
Before and Immediately After the Intervention
Method of measurement
Laboratory Kit
8
Description
Cholesterol
Timepoint
Before and Immediately After the Intervention
Method of measurement
Laboratory Kit
9
Description
Triglyceride
Timepoint
Before and Immediately After the Intervention
Method of measurement
Laboratory Kit
10
Description
Troponin I
Timepoint
Before and Immediately After the Intervention
Method of measurement
Laboratory Kit
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: using hydroalcoholic extract of purslane plant with a dose of 500 mg, orally, twice a day for 4 weeks
Category
Treatment - Drugs
2
Description
Control group: receiving placebo along with standard treatment during the intervention
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Jalil Hospital
Full name of responsible person
Masoumeh Alizadeh
Street address
Emam Reza
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7001
Email
shahidjalil@yums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Seyeed Amin Hoseini Motlagh
Street address
Shahid Motahari
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
research@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Rozina Abbasi Larki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Zarei Educational Campus, Beach Park Near Imam Sajjad (AS) Hospital, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3323 5153
Email
kian1380@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Rozina Abbasi Larki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Zarei Educational Campus, Beach Park Near Imam Sajjad (AS) Hospital, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3323 5153
Email
kian1380@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Rozina Abbasi Larki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Zarei Educational Campus, Beach Park Near Imam Sajjad (AS) Hospital, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3323 5153
Email
kian1380@yahoo.com
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
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
Title and more details about the data/document
After The Completion Of The Study, Only The Data On The Main Outcomes Will Be Shared.
When the data will become available and for how long
Two Months After Completing The Study
To whom data/document is available
After Completing The Study, All Academic People Related to The Subject Can Access The Data
Under which criteria data/document could be used
Using The Information And Results of The Study With Legal Citation to The Article Will Be Unimpeded.
From where data/document is obtainable
The Corresponding Author is Dr. Rozina Abbasi Laraki
Email: kian1380@yahoo.com
What processes are involved for a request to access data/document
Applicants Must Submit Their Official Application Via Organizational Email to The Corresponding Author's email. If The Author Approves The Information, She Will Provide The Information to the Applicant Within Two Weeks.