The goal of present study is the evaluation of the effect of Alhagi maurorum on urolithiasis in children. In this study, children over 2 years old with urinary stone (with size greater than 2 mm) which didn't reply to usual care (Potassium Citrate) and have inclusion criteria after receiving informed consent enter to study. They will receive Alhagi maurorum (0.5 cc/kg- Nader Company) for a month . At the end, results (reducing the size of stone or dispose of it in an ultrasound examination) will be discussed. Parents also will be explained that in unresponsive to therapy patients, treatment should be continued for up to 6 months. But in order to avoid long-term use of the drug and the imposition of side effects, an alternative treatment is SANKOL drop or sweat camelthorn. Inclusion criteria: children older than 2 years with urinary stone that have not responded to treatment with poly citrate. Exclusion criteria: unwillingness to cooperate; history of allergy to herbal medicines. This study is nonrandomized clinical trial. The study will be done on 30 children with urinary stone.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050333428N3
Registration date:2017-06-12, 1396/03/22
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-06-12, 1396/03/22
Registrant information
Name
Elham Bakhtiari
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3727 3943
Email address
bakhtiarie@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Expected recruitment start date
2017-07-06, 1396/04/15
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Alhagi maurorum on urinary tract stones improvement in children over two years
Public title
effect of Alhagi maurorum on urinary tract stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children older than 2 years with urinary stone that have not responded to treatment with poly citrate
Exclusion criteria:
lack of willingness to cooperate; history of allergy to herbal medicines
Age
From 2 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Mashhad University of Medical Sciences
Street address
Azadi squere, Mashhad
City
Mashhad
Postal code
Approval date
2017-05-03, 1396/02/13
Ethics committee reference number
IR.MUMS.fm.REC.1396.37
Health conditions studied
1
Description of health condition studied
urolithiasis
ICD-10 code
N20.2
ICD-10 code description
Calculus of kidney with calculus of ureter
Primary outcomes
1
Description
size of stone
Timepoint
before and one month after intervention
Method of measurement
sonogarghy
Secondary outcomes
empty
Intervention groups
1
Description
intervention group: Alhagi maurorum, 0.5 cc/kg, Nader Company, one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Nephrology Clinic of Dr Sheikh Hospital
Full name of responsible person
Dr. Anoush Azarfar
Street address
Dr. Sheikh Hospital, Gharani BLV,Mashhad
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Azadi Squere, Mashhad University of Medical Sciences
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Anoush Azarfar
Position
Pediatric Nephrology specialists
Other areas of specialty/work
Street address
Gharani BLV, Dr Sheikh Hospital
City
Mashahd
Postal code
Phone
+98 51 3727 3943
Fax
Email
Azarfara@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Anoush Azarfar
Position
Pediatric Nephrology specialists
Other areas of specialty/work
Street address
Gharani BLV, Dr Sheikh Hospital
City
Mashhad
Postal code
Phone
+98 51 3727 3943
Fax
Email
Azarfara@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Anoush Azarfar
Position
spacialist medicine
Other areas of specialty/work
Street address
Dr Sheikh Hospital
City
Mashhad
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)