Pilot study on the effectiveness of selected natural products from traditional Iranian medicine sources (Bore armani and Raphanus niger Mill. combination/mixture) on the treatment of kidney stones
Evaluating the effect of selected natural product (Bore armani and Raphanus niger Mill. combination/mixture) in the treatment of kidney stones
Design
The pilot study was performed on 10 patients with kidney stones 10 mm and smaller in size, which was 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 . 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
Inclusion criteria: 1- Age 20-60 years 2- Presence of kidney or ureteral stones smaller than 10 mm based on ultrasound report 3- Absence of emergency conditions in the patient 4- Non-pregnancy and lactation in women 5- Blood creatinine less than 1.4 mg / dl 6- No kidney tumors 7- No insulin-dependent diabetes 8- No herbal medicine for kidney stones
Inclusion criteria: 1- Existence of uncontrollable pain 2- Emergency cases of kidney stones or the need for surgical interventions
Intervention groups
Evaluation of the effectiveness of natural medicine and evaluation of possible side effects of the drug during treatment on the size and number of kidney and ureteral stones in patients by ultrasound and blood tests and a questionnaire are evaluated.
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:IRCT20200112046087N3
Registration date:2020-08-12, 1399/05/22
Registration timing:registered_while_recruiting
Last update:2020-08-12, 1399/05/22
Update count:0
Registration date
2020-08-12, 1399/05/22
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
2020-04-20, 1399/02/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Pilot study on the effectiveness of selected natural products from traditional Iranian medicine sources (Bore armani and Raphanus niger Mill. combination/mixture) on the treatment of kidney stones
Public title
A pilot study to evaluate the effectiveness of selected drugs from traditional medicine sources on the treatment of kidney stones
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
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
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
2019-05-05, 1398/02/15
Ethics committee reference number
IR.SBMU.RETECH.REC.1398.050
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
Intervention group: Patients with kidney stones with a size of 10 mm and smaller than those diagnosed by ultrasound and according to their blood and urine tests are included in the plan with the opinion of a doctor. Patients take 2 oral capsules of 500 mg 3 times a day. This capsule contains powder obtained from the aqueous extract of black horseradish and also the powder of Armenian sugar. In this project, toxicological tests, etc. have been performed on the Armenian sugar used in this combination and its safety has been evaluated. . The duration of the intervention is one week.
Category
Treatment - Drugs
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
Medical doctor
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
Web page address
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
Medical doctor
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
Medical doctor
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Blood and urine analysis data and ultrasound results 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
Data will be available after the article is published.
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
After the email to Dr. Ilkhani, the information will be provided at her discretion and with the approval of the research assistant of Shahid Beheshti Faculty of Traditional Medicine.