Investigating the effect of palm kernel on kidney stones passing
Design
A randomized, controlled, double-blind, placebo-controlled clinical trial
Settings and conduct
In this study, patients referred to Imam Reza Hospital Kermanshah Clinic between the ages of 18 and 60 of both sexes with kidney stones smaller than 8 mm and located in upper and middle calyces were studied for three months after obtaining consent. Patients are divided into case and control groups.
In each group, 20 participants in the control group were given conventional kidney stone remedies, such as diuretic and potassium citrate, and the treated group received 10 cc syrup every 8 hours. Patients are monitored monthly by ultrasound, blood and urine examinations and evaluated on the basis of shrinkage or excretion. They follow.
Participants/Inclusion and exclusion criteria
Age over 18 years old. The ability to swallow and eat the syrup used in the design. Have the necessary co-operation in the design. There is no allergen to any herbal remedy. The size of stones must not be larger than 8mm. They must be in middle and/or upper calyx.
Intervention groups
The syrup prepared from date kernel will be prescribed to the intervention group and routine treatment such as diuretics and potassium citrate will be given to the controlled group.
Main outcome variables
Stone size, passing of kidney stones, serological tests (Bun, Cr) and clinical exam for investigation for any complication
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170225032756N2
Registration date:2019-11-05, 1398/08/14
Registration timing:retrospective
Last update:2019-11-05, 1398/08/14
Update count:0
Registration date
2019-11-05, 1398/08/14
Registrant information
Name
Marzieh Marami haji agha
Name of organization / entity
Kermanshah Medical University
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6480
Email address
yshokoohinia@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chanceller for research of Kermanshsh Medical University
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-04-21, 1398/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of syrup of Palm kernel extract on stone size in patients with kidney stones
Public title
Evaluation of the effect of Palm kernel on size of kidney stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age is over 18 years old.
The patient signs the written consent and co-operates during the study. (In cases where the patient is illiterate, the consent form is read by the researcher and, if consent is given, to the patient.)
stone size (less than 8 mm)
number of stones between 1-5
location of stones in the kidneys in middle and/or upper calyx
Exclusion criteria:
Pregnant patients and nursing mothers
Patients who are compelled to take other medications that interfere with recent treatment
Patients with clinical conditions who are at risk of serious health
Patients with severe plant allergy
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization has been done in intervention and control groups by blocking method. Using the Excel sheet, we generated 20 groups with the block size of 2 people in each. Finally, we used the "Random" command to calculate the probability for each group. By sorting the probability, we selected 40 people, each allocated to intervention or those who received routine care.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, blind patients and researchers are kept. Each patient received a sealed envelop containing the relevant code for the type of intervention. Patients will be prescribed to receive whether palmicort syrup or routine treatment from the drugstore in the university clinic. Therefore, although, the nephrologist was not blind, the radiologist and other researchers from school of pharmacy were blind. In addition, as both groups received medication, they are not aware of whether they have received the routine care or new treatment.
Placebo
Used
Assignment
Parallel
Other design features
Doubling Succession and Single Central
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Building No 2, shahid beheshti Blv., Kermanshah University of Medical Sciences, Kermansshah, Iran
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2016-07-13, 1395/04/23
Ethics committee reference number
kums.rec.1395.271
Health conditions studied
1
Description of health condition studied
kidney stone
ICD-10 code
N00-N99
ICD-10 code description
xIv
Primary outcomes
1
Description
the size of kidney stones; size of kidney stones will be assessed by a radiologist using sonography.
Timepoint
every month after starting the treatment until 3 months
Method of measurement
sonography
2
Description
Expulsion of stone
Timepoint
once a month
Method of measurement
sonography
Secondary outcomes
1
Description
Hypertension: in those without history of high blood pressure, recording a blood pressure > 140/90
Timepoint
once a week after the starting of treatment
Method of measurement
measurement in physician office
Intervention groups
1
Description
Intervention group : three times a day, every 8 hours, two tablespoons per meal or 5 cc Contains 4 gr active ingredient.Such patients receive low salt, low fat and low animal protein diet.
Category
Treatment - Drugs
2
Description
Control group: patients receive routing treatment for kidney stones by PI (nephrologist) including diuretics plus potasium citrate. Such patients receive low salt, low fat and low animal protein diet.