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Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones

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ClinicalTrials.gov Identifier: NCT00381849
Recruitment Status : Completed
First Posted : September 28, 2006
Results First Posted : August 6, 2012
Last Update Posted : February 4, 2016
Sponsor:
Collaborators:
Himalaya Herbal Healthcare
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Stephen B. Erickson, M.D., Mayo Clinic

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions: Cystinuria
Nephrolithiasis, Calcium Oxalate
Interventions: Drug: Cystone
Drug: Sugar Pill (Placebo)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients with recurring and analytically confirmed kidney stones were recruited from the Mayo Stone Clinic in Rochester, MN.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Calcium Stone Subjects Subjects with confirmed calcium kidney stone(s)
Cystine Stone Subjects Subjects with confirmed cystine kidney stone(s)

Participant Flow for 4 periods

Period 1:   First Intervention
    Calcium Stone Subjects   Cystine Stone Subjects
STARTED   10   10 
COMPLETED   10   10 
NOT COMPLETED   0   0 

Period 2:   Wash Out
    Calcium Stone Subjects   Cystine Stone Subjects
STARTED   10   10 
COMPLETED   10   9 
NOT COMPLETED   0   1 
Withdrawal by Subject                0                1 

Period 3:   Second Intervention
    Calcium Stone Subjects   Cystine Stone Subjects
STARTED   10   9 
COMPLETED   10   9 
NOT COMPLETED   0   0 

Period 4:   Open-label
    Calcium Stone Subjects   Cystine Stone Subjects
STARTED   10   9 
COMPLETED   10   9 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Calcium Stone Subjects Subjects with confirmed calcium kidney stone(s)
Cystine Stone Subjects Subjects with confirmed cystine kidney stone(s)
Total Total of all reporting groups

Baseline Measures
   Calcium Stone Subjects   Cystine Stone Subjects   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   10   20 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   8   9   17 
>=65 years   2   1   3 
Gender 
[Units: Participants]
     
Female   6   4   10 
Male   4   6   10 
Region of Enrollment 
[Units: Participants]
     
United States   10   10   20 


  Outcome Measures

1.  Primary:   24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)   [ Time Frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment ]

2.  Primary:   24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)   [ Time Frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment ]

3.  Primary:   24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)   [ Time Frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment ]

4.  Primary:   24 Hour Urinary Cystine Excretion   [ Time Frame: baseline, after 6 weeks treatment on placebo, after 6 weeks treatment on cystone, at end of 46 weeks of open label cystone treatment ]

5.  Primary:   Stone Density as Measured by Agatston Score Via Computerized Tomography   [ Time Frame: Baseline, approximately 52 weeks after baseline ]

6.  Primary:   Volume of Kidney Stones as Measured on Computerized Tomography   [ Time Frame: Baseline, approximately 52 weeks after baseline ]

7.  Secondary:   Change in Stone Burden as Assessed by Radiologist at One Year   [ Time Frame: Baseline, approximately 52 weeks after baseline ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
There were no serious adverse events and no adverse events. Power of the study was diminished by failure of patients to return all required 24 hour urine samples. The botanical authenticity of Cystone was not documented.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Beverly Tietje, Study Coordinator
Organization: Mayo Clinic
phone: 507-255-0401
e-mail: tietje.beverly@mayo.edu


Publications of Results:

Responsible Party: Stephen B. Erickson, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00381849     History of Changes
Other Study ID Numbers: 2115-05
P50DK083007 ( U.S. NIH Grant/Contract )
First Submitted: September 27, 2006
First Posted: September 28, 2006
Results First Submitted: April 12, 2011
Results First Posted: August 6, 2012
Last Update Posted: February 4, 2016