Evaluating the effect of green tea extract on stone formation in patients with calcium oxalate kidney stones
Design
On day zero, sixth and twelfth weeks of the study, in the same laboratory, 10 cc of venous blood sample is taken. After serum separation, the urea and creatinine level in plasma of the participants will be evaluated using specific kits and ELISA method. The Sonography method will be applied for evaluating the size of stones on day of zero, the sixth and twenty first weeks of the study.
Settings and conduct
60 patients with kidney stones from (Velayat hospital, Qazvin University of Medical Sciences, Urology center) will be chosen as the patients group.
Participants/Inclusion and exclusion criteria
Willing to collaboration
Having calcium oxalate kidney stones
Ages between 30-60
Invariability of treatment method and medications in last two months
Normal physical activity level
No pregnancy and lactation
No liver disorders and diabetes
Intervention groups
The participants are divided in to two groups:
first intervention group (patients); oral administration of green tea extract capsules (two times a day, each time: 225 mg) for 12 weeks.
second intervention group (control group); oral administration of distilled water capsules ( two times a day).
Main outcome variables
The size of the stone, analyzing the biochemical factors of blood and urine
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200918048747N1
Registration date:2020-12-07, 1399/09/17
Registration timing:registered_while_recruiting
Last update:2020-12-07, 1399/09/17
Update count:0
Registration date
2020-12-07, 1399/09/17
Registrant information
Name
Alireza Farasat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 6001
Email address
a.farasat@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-26, 1399/07/05
Expected recruitment end date
2020-12-25, 1399/10/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of green tea extract on the size of urinary stone in patients with calcium kidney stones
Public title
Evaluating the effect of green tea extract on the size of urinary stone in patients with calcium kidney stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to collaboration
Having Calcium oxalate kidney stone
Invariability of treatment method and medications in last two months
Normal physical activity level
Exclusion criteria:
Pregnancy and lactation
Patients with liver disorders, diabetes, acute metabolic disorders and allergy
Food supplement consumption from last two months to the end of the study
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation can be made in blocks which was used in this study. The participants are divided in to two groups of control and test using block randomization method. The size of each block will be equal to 2, 4 and 8 samples. After block allocation, the individuals will choose one of the treatments randomly. It should be noted that for the patient, specialist and the researcher, the difference of two treatments will be unclear. The control group will receive only their usual treatment.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this method (single blind), the samples (patients and control groups) don't know the type of intervention or treatment but the researcher or treatment staff are aware.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Qazvin University of Medical Sciences
Street address
Qazvin University of Medical Sciences, Shahid Bahonar St.
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Approval date
2019-09-01, 1398/06/10
Ethics committee reference number
IR.QUMS.REC.1398.136
Health conditions studied
1
Description of health condition studied
Kidney stone
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
The Oxalate, Creatinine and Uric acid level
Timepoint
Before and after intervention
Method of measurement
The detection kit
Secondary outcomes
1
Description
Size of stone
Timepoint
Before and after intervention
Method of measurement
Sonography
Intervention groups
1
Description
The participants are divided in to two groups: first intervention group (patients); oral administration of green tea extract capsules (two times a day, each time: 225 mg) for 12 weeks
Category
Treatment - Other
2
Description
Control group: second intervention group (control group); oral administration of distilled water capsules (two times a day).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat Hospital
Full name of responsible person
Alireza Farasat
Street address
Qazvin University of Medical Sciences, Shahid Bahonar st.
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Mehdi Emam Jome
Street address
Qazinvin University of Medical Sciences, Shahid Bahonar St.
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Alireza Farasat
Position
Professor Assistant
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Qazvin University of Medical Sciences, Shahid Bahonar St.
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
info@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Shabnam Zarei
Position
Master of Science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Sciences, Shahid Bahonar St.
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
Shabnamdiet6@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Shabnam Zarei
Position
Master of science
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Qazvin University of Medical Sciences, Shahid Bahonar St.
City
Qazvin
Province
Qazvin
Postal code
15315-34199
Phone
+98 28 3333 6001
Email
Shabnamdiet6@gmail.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