Determining the effect of Rudioretic supplement on kidney stone expulsion
Design
160 participants (no=40 per group) are randomly assigned to 2 intervention groups (A- capsule, B- drops) and 2 placebo groups (C- capsule, D- drop) using a random digit table. Study phase 3.
Settings and conduct
This randomized controlled trial will be performed in Fayaz Bakhsh hospital. Inclusion criteria will be checked by a sonographer. Included patients will randomly be assigned to supplement and placebo groups. In the end, sonography will be repeated. Before and after 6 weeks of intervention urine biochemical test, 24h urine volume and urine pH will be determined. At last, the rate of stone expulsion will compare in two groups with SPSS 22 software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age>18, having kidney stone without hydronephrosis, No need for medication. Exclusion criteria: Pregnancy, lactation, Receiving drugs that affect kidney stones.
Intervention groups
Patients in intervention group (A) will receive 2 capsules (500 mg) of Rudioretic every 8 hours with empty stomach. Intervention group (B) will consume 40 drops of Rudioretic every 8 hours. Placebo group (C) will receive placebo capsule every 8 hours and placebo group (D) will receive 40 drops of placebo every 8 hours. Rudioretic capsule and drop contain similar amount of Zea mays, Apium graveolens, Equisetum arvense and Urtica dioica L. Placebo capsules and drop contain maltodextrin. All groups receive supplement or placebo for 6 weeks
Main outcome variables
Excreted kidney stone number
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140804018677N12
Registration date:2021-08-17, 1400/05/26
Registration timing:prospective
Last update:2021-08-17, 1400/05/26
Update count:0
Registration date
2021-08-17, 1400/05/26
Registrant information
Name
soodeh razeghi Jahromi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8500
Email address
razeghi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-11, 1400/06/20
Expected recruitment end date
2022-02-09, 1400/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Rudioretic supplement comparing to placebo on renal stone: A randomized clinical trial
Public title
Rudioretic supplement and kidney stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosed with a kidney stone without hydronephrosis and no need for medication
Age between 18-45 years
Willing to participate in the study
Exclusion criteria:
Pregnancy or lactation
Having known heart disease
Receiving drugs that affect kidney stones
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
160
Randomization (investigator's opinion)
Randomized
Randomization description
The Block Randomization method is used to randomize the patients. For randomization, we will visit www.sealedenvelope.com and use the randomization tab to make a list considering the number of intervention groups, sample size, block size. Block size will be 8 (AABBCCDD and other compositions). The prepared list that contains the pattern of patient allocation will be obtained and used. This site is designed in such a way that there is no limit on the number of groups for random allocation. According to the total number of samples required for the study, which is 160 patients: 40 patients in the intervention group with capsule (A), 40 patients in the intervention group with drop (B), 40 patients in the control group with capsule (C), and patients in the control group with drop. blocks will be randomly Then 160 pockets (40 pockets containing paper containing A, 40 containing B, 40 pockets containing C, and 40 pockets containing D) will be prepared based on sample size. According to a list of blocks, a trained person will be set the row of pockets. After the admission of each patient will be given a pocket and assigned to Group A (intervention 1) or B (intervention 2) or C (control group 1) or D (control group 2). The sampling process will be performed sequentially until the end of the completion of the sample size.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of research and technology deputy of Shahid Beheshti University of Medical Sciences
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Approval date
2019-02-17, 1397/11/28
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.1304
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
Number of excreted kidney stone
Timepoint
Start of intervention and a month later
Method of measurement
Ultrasonography and blood and urine tests
2
Description
Stone size
Timepoint
Start of intervention and a month later
Method of measurement
Sonography
Secondary outcomes
1
Description
urine volume 24 h
Timepoint
Start of intervention and a month later
Method of measurement
Urine 24 h test by BT-1500 autoanalyser
2
Description
Creatinine in urine 24h
Timepoint
Start of intervention and a month later
Method of measurement
Urine 24h test by Pars Azmoon kit
3
Description
oxalate in urine 24 h
Timepoint
Start of intervention and a month later
Method of measurement
urine 24 h test by Darmankau kit
4
Description
Citrate in urine 24 h
Timepoint
Start of intervention and a month later
Method of measurement
urine 24 h test by Darmankau kit
5
Description
Uric acid in urine 24 h
Timepoint
Start of intervention and a month later
Method of measurement
urine 24h test by Pars Azmoon kit
6
Description
Urine specific gravity
Timepoint
Start of intervention and a month later
Method of measurement
Urinalysis by BT-1500 autoanalyser
Intervention groups
1
Description
Supplement group A: will receive 2 capsules of Rudioretic every 8 hours with empty stomach for 6 weeks. Each capsule contain 500 mg of Zea mays, Apium graveolens, Equisetum arvense and Urtica dioica L.
Category
Treatment - Other
2
Description
Supplement group B: will receive 40 drops of Rudioretic every 8 hours with empty stomach for 6 weeks. Rudioretic contain Zea mays, Apium graveolens, Equisetum arvense and Urtica dioica L.
Category
Treatment - Other
3
Description
Placebo group C: will receive 2 capsules of placebo contains maltodextrine every 8 hours for 6 weeks .
Category
Placebo
4
Description
Placebo group D: will receive 40 drops of placebo contains maltodextrine every 8 hours for 6 weeks .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Fayaz Bakhsh hospital
Full name of responsible person
Soodeh Razeghi Jahromi
Street address
No. 7, West Arghavan Ave., Farahzadi Blvd., Qods Town,
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razghei Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razghei Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Soodeh Razghei Jahromi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
No. 7, West Arghavan St., Farahzadi Blv., Qods Town
City
Tehran
Province
Tehran
Postal code
1981619573
Phone
+98 21 2235 7483
Email
soodehrazeghi@gmail.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data would be available to public
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
To all
Under which criteria data/document could be used
No other critaria
From where data/document is obtainable
Email to soodehrazeghi@gmail.com
What processes are involved for a request to access data/document