Protocol summary

Study aim
Evaluating the effect of selected natural product (Bore armani and Raphanus niger Mill. combination/mixture) compared to placebo in the treatment of kidney stones
Design
A randomized, double-blind, placebo-controlled clinical trial study was performed on 70 patients with kidney stones 10 mm smaller than those diagnosed by ultrasound.
Settings and conduct
Patients with kidney and ureteral stones with a size of less than 10 mm who refer to Shariat Panahi Clinic, after the doctor's opinion, enter this study of two blind sides (the patient and the researcher are blind). Patients drink the medicine half an hour before breakfast and half an hour before lunch and half an hour before dinner in the evening with a glass of warm water sweetened with a tablespoon of honey. In order to evaluate the effectiveness and safety of the drug, it will be evaluated.
Participants/Inclusion and exclusion criteria
Patients with kidney stones 10 mm in size and smaller than those diagnosed by ultrasound are performed. Inclusion criteria: 1. Age: 20-60 years 2. Kidney or ureteral stones less than 10 mm in size, according to ultrasound reports 3. Absence of emergency conditions in the patient 4. Non-pregnancy and lactation in women 5-Creatinine blood less than 1.4 mg / dl 6. No kidney tumors 7. No insulin-dependent diabetes 8. Not taking any herbal medicine to excrete kidney stones Exclusion criteria: 1- Uncontrollable pain 2. Emergency cases of kidney stone or need for surgical intervention
Intervention groups
We will compare the effect of natural medicine and placebo during treatment on the patients with a size less than 10 kidney stone
Main outcome variables
Comparison of renal stone size by renal ultrasound and 24-hour urinary calcium, magnesium, citrate and oxalate levels, also liver enzymes (ALT,AST), creatinine, blood urea nitrogen (BUN) in the two groups before and after drug administration.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200112046087N2
Registration date: 2020-05-18, 1399/02/29
Registration timing: prospective

Last update: 2020-05-18, 1399/02/29
Update count: 0
Registration date
2020-05-18, 1399/02/29
Registrant information
Name
Hanieh Babaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8877 3521
Email address
haniehbabaei92@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of selected natural product (Bore armani and Raphanus niger Mill. combination/mixture) compared to placebo in the treatment of kidney stones, a double-blind study
Public title
Evaluation of the efficacy of natural product with placebo on renal stone therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Kidney or ureteral stones less than 10 mm in size, according to ultrasound reports Pregnancy and lactation in women No kidney tumors Lack of emergency conditions in the patient No insulin-dependent diabetes Not taking any herbal medicine for kidney stones Blood creatinine less than 1.4 mg/dl 20-60 years
Exclusion criteria:
Severe urinary tract infection Emergency cases of kidney stones or the need for surgical intervention
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 70
More than 1 sample in each individual
Number of samples in each individual: 1
Patients with kidney stones smaller than 10 mm
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization. Block randomization is used with 4 blocks, which will be used to generate random sequences using Random Allocation software. Due to randomly generated sequences, patients enter the control and intervention groups. As these patients will be referred by the treating physician to the planter, a list of the names of the nominees will be provided with a row number, and a coin will be used to decide whether or not to assign the numbers to the intervention group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this plan, the drug and placebo are prepared by the pharmacist. After preparing the drug, the pharmacist will insert a specific code of the medicine on the bottle. These codes are only available to the pharmacist, and no one knows what kind of medicine (medicine or placebo) until the end of the study. The shape and size of all drugs are the same and indistinguishable. Therefore, the project implementer uses the drugs randomly for each patient. At the end of the study, after collecting the data, with the help of a pharmacist, the codes related to the drug and the drug facade are distinguished from each other, but information about the drug and placebo is hidden for the analyzer. Only at the end of the study, The codes are decrypted and the necessary information is provided to the executor.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical sciences, Daneshju Blv.
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2020-02-09, 1398/11/20
Ethics committee reference number
IR.SBMU.REC.1398.160

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 size of the stone
Timepoint
Before entering the study (before starting the drug) and 8 days after starting the drug
Method of measurement
Kidney ultrasound

Secondary outcomes

empty

Intervention groups

1

Description
Patients with kidney stones 10 mm in size and smaller than those diagnosed by ultrasound are screened by a physician based on their blood and urine tests. Patients take 2 oral capsules 3 times a day. This capsule contains the500 mg powder of blue horseradish extract and the Armenian borax powder in equal proportions. The drug was previously developed under a separate approved plan. In that plan, toxicological tests, etc., have been performed on the Armenian boulder used in this compound, and its safety has been evaluated. The intervention lasts one week.
Category
Treatment - Drugs

2

Description
Patients with kidney stones 10 mm in size and smaller than those diagnosed by ultrasound are screened by a physician based on their blood and urine tests. Patients take 2 placebo capsules 3 times, before each meal for one week. The prescribed capsule in the control group contains 500 mg of powdered dry Sangag bread. Which is packaged in exactly the same way as the intervention capsules
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Faculty of Traditional Medicine (Shariat Panahi Health School)
Full name of responsible person
Reza Ilkhani
Street address
No. 8, Shams Alley, Vali-e Asr Ave, The Faculty of Traditional Medicine of Shahid Beheshti University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
ilkhanir@sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti Faculty of Traditional Medicine
Full name of responsible person
Somayeh Esmaeili
Street address
No. 8, Shams Alley, Vali-e Asr Ave, The Faculty of Traditional Medicine of Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
sesmaeili@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti Faculty of Traditional Medicine
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
Reza ilkhani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Alley, Vali-e Asr Ave, The Faculty of Traditional Medicine of Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
ilkhanir@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Ilkhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Alley, Vali-e Asr Ave, The Faculty of Traditional Medicine of Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
ilkhanir@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Reza Ilkhani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 8, Shams Alley, Vali-e Asr Ave, The Faculty of Traditional Medicine of Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
ilkhanir@sbmu.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Information on changes in urinary, blood, and sonographic parameters of patients
When the data will become available and for how long
1401
To whom data/document is available
Researchers working in academic and academic institutions
Under which criteria data/document could be used
Request a printed article and oral explanations and guidance by email and academic identity
From where data/document is obtainable
In charge of Dr. Reza Ilkhani's plan. Email: ilkhanir@sbmu.ac.ir
What processes are involved for a request to access data/document
Email information to Dr. Ilkhani will be provided if he so desires and with the research assistant of Shahid Beheshti Traditional School of Medicine approve
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