1. Home
  2. Approved trials
  3. » فارسی

Clinical trial on the effectiveness of Talkhab spring water on urine indices in idiopathic calcium oxalate stone former

Protocol summary

Summary
Objective: Non-randomized clinical trial on the effectiveness of Talkhab spring water in urine indices of idiopathic calcium oxalate stone former. Study population: Males aged over 18 with idiopathic calcium oxalate stone disease. Inclusion criteria: Male; history of idiopathic calcium oxalate stone formers; contraindications of supplements such as citrate, vitamin D, vitamin C, calcium, and medications; not taking too much salt; absence of any possible complications of metabolic disorders such as diabetes, hepatitis, cardiac failure; no complications of urinary tract such as hydronephrosis, nephrolithiasis, azotemia, and renal colic. Exclusion criteria: No complications of idiopathic calcium oxalate stone; no use of supplements such as citrate, vitamin D, vitamin C, calcium and medications; taking too much salt; having any possible complications of metabolic diseases such as diabetes, hepatitis, and cardiac failure; having urolithiasis such as urinary tract, nephrolithiasis, azotemia, and renal colic. Sample: Sixty samples were allocated to the intervention (n=30) and control (n=30) groups. Study intervention: Use of Talkhab spring water in patients sustaining idiopathic calcium oxalate stone. The study outcome: Urine indices and volume were evaluated before and 24 hours after the intervention. Urine calcium levels were compared in each group to determine the effect of Talkhab spring water on the patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015121325507N1
Registration date: 2015-12-26, 1394/10/05
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-12-26, 1394/10/05
Registrant information
Name
Ali Serous
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3841 4499
Email address
m-jiriaie@mscstu.scu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Arak University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial on the effectiveness of Talkhab spring water on urine indices in idiopathic calcium oxalate stone former
Public title
Effectiveness of spring water for treatment of nephrolithiasis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Male; history of idiopathic calcium oxalate stone formers; contraindications of supplements such as citrate, vitamin D, vitamin C, calcium, and medications; not taking too much salt; absence of any possible complications of metabolic disorders such as diabetes, hepatitis, cardiac failure; no complications of urinary tract such as hydronephrosis, nephrolithiasis, azotemia, and renal colic. Exclusion criteria: No complications of idiopathic calcium oxalate stone; no use of supplements such as citrate, vitamin D, vitamin C, calcium and medications; taking too much salt; having any possible complications of metabolic diseases such as diabetes, hepatitis, and cardiac failure; having urolithiasis such as urinary tract, nephrolithiasis, azotemia, and renal colic.
Age
From 18 years old to 90 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Vice Chancellor for Research, Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
3819693345
Approval date
2015-04-21, 1394/02/01
Ethics committee reference number
IR.ARAKMU.REC.1394.221

Health conditions studied

1

Description of health condition studied
kidney stones
ICD-10 code
N20.0
ICD-10 code description
Stone in kidney

Primary outcomes

1

Description
Urinary indices
Timepoint
24 hours before and after use of Talkhab spring water
Method of measurement
Urinalysis

Secondary outcomes

1

Description
Urine volume
Timepoint
24 hours before and after use of Talkhab spring water
Method of measurement
Urinalysis

Intervention groups

1

Description
Intervention group: Patients with idiopathic calcium oxalate stone received Talkhab spring water on a daily basis. Measurement of urine calcium before and 24 hours after the intervention.
Category
Treatment - Drugs

2

Description
Control group: Patients with idiopathic calcium oxalate stone received natural water on a daily basis. Measurement of urine calcium before and 24 hours after the intervention.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Ali Sirous
Street address
Valiasr Hospital- Pyrozi Avenue
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research of Arak University of Medical Sciences
Full name of responsible person
Ali Asghar Yaghobi
Street address
Vice Chancellor for Research, Arak University of Medical Sciences, A'lam-Al-Hoda Street,Shahid Shiroodi Street
City
Arak
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 of Arak 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
Arak University of Medical Sciences
Full name of responsible person
Ali Sirous
Position
Urologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Phone
+98 86 3313 6058
Fax
Email
m-jiriaie@mscstu.scu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Parvin Soltani
Position
Urologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Phone
+98 86 3224 9801
Fax
Email
Soltaniparvin@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Ali Sirous
Position
Urologist
Other areas of specialty/work
Street address
Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Phone
+98 86 3313 6058
Fax
Email
m-jiriaie@mscstu.scu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...