Library study of kidney stone dissolving medicaments in Persian medicine and evaluation of a related multi-ingredient formulation in dissolving calcium kidneystones; a double-blind randomized clinical trial
Preparation of new herbal formulations for kidney stones
Design
Sixty patients will be divided into two groups of 30, one group will receive medication for 6 weeks and the control group will receive a placebo. At the beginning and end of the study, the results of the analysis of urine and blood samples and imaging will be examined.
Settings and conduct
The study is done in Motahhari and Imam Reza clinics affiliated to Shiraz University of Medical Sciences.After examining the patient and confirming the conditions for admission to the study and obtaining informed consent, the doctor will provide the patient with a medicine or placebo.
Participants/Inclusion and exclusion criteria
Age 18 years and older
5 mm calcium kidney stones in the lower lobe
Willingness to participate in the study
No pregnancy and lactation
Lack of acute and chronic renal failure
Intervention groups
30 patients in intervention group consume 2 capsules of freeze dried water extract of 6 plants daily. 30 patients in control group consumes 2 capsules of wheat flour as placebo daily.
Main outcome variables
kidney function test, liver function test, Ca and P serum levels, urine analysis, 24 h urine volume and stone diameter
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191212045709N1
Registration date:2020-09-29, 1399/07/08
Registration timing:registered_while_recruiting
Last update:2020-09-29, 1399/07/08
Update count:0
Registration date
2020-09-29, 1399/07/08
Registrant information
Name
Ramin Ansari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4255
Email address
ansariramin94@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-15, 1398/10/25
Expected recruitment end date
2020-11-21, 1399/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Library study of kidney stone dissolving medicaments in Persian medicine and evaluation of a related multi-ingredient formulation in dissolving calcium kidneystones; a double-blind randomized clinical trial
Public title
Library study of kidney stone dissolving medicaments in Persian medicine and evaluation of a related multi-ingredient formulation in dissolving calcium kidneystones; a double-blind randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 years and older
Calcium kidney stones with a size of 5 mm or more based on imaging results
Lack of confirmed history of acute renal failure
Lack of confirmed history of chronic kidney disease
having no present urinary tract infection
no concurrent use of medications including:®Sankol، ®Rowatinex and Cystone®
no pregnancy or breast feeding
Exclusion criteria:
Age 18 years and older
Calcium kidney stones with a size of 5 mm or more based on imaging results
Lack of confirmed history of acute renal failure
Lack of confirmed history of chronic kidney disease
having no present urinary tract infection
no concurrent use of medications including:®Sankol، ®Rowatinex and Cystone®
no pregnancy or breast feeding
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 60 patients were randomly divided in to two groups of
30 each in a randomized double-blind placebo-controlled design using permuted block randomization method.
The sample size and randomization were done by a computer-
generated statistical program. Minimum sample size for each
group was 13 patients. All patients received either 2 capsules of
drug or identical-looking placebos at a dose of 2 capsules
once daily for a period of 6 weeks.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be a double blind trial and only the evaluator knows the results and the code of the drug or placebo group.The capsules of the drug group and the placebo are quite similar in appearance.The drug and placebo groups will be separated by receiving a code.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
anvari str- zand blvd- shiraz
City
shiraz
Province
Fars
Postal code
7139745197
Approval date
2019-11-06, 1398/08/15
Ethics committee reference number
IR.SUMS.REC.1398.924
Health conditions studied
1
Description of health condition studied
renal stone
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
liver function test- renal function test-Ca and P serum level, urine analysis, 24 hour urine volume and stone diameter
Timepoint
At the beginning of the study and one month after the end of the course of medication
Method of measurement
KUB- URINE ANALYSIS-BLOOD ANALYSIS
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group consumes 2 capsules (one in the morning and one at night) of freeze dried water extract of 6 plants including: Tribulus terrestris-Foeniculum vulgare-Pimpinella anisum- Cucumis sativus-Cucurbita pepo-Apium graveolens. the control group consumes 2 capsules of wheat flour as placebo daily. Blood sample and 24 hours urine of patients will analized at the beginning and end of the study and the imaging will be done for analizing the size and number of stones.