Use of an Herbal Preparation to Prevent and Dissolve Kidney Stones

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT00381849
• Collaborator: Himalaya Herbal Healthcare (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 20
• Location: 1
• Arms: 3
• Duration (Months): 50
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

We will investigate the safety and effectiveness of a mixture of 9 east Indian herbs known as Cystone regarding their ability to dissolve existing kidney stones and prevent formation of new ones. Cystine and calcium stone formers will be recruited for a 59 week trial. The first phase of the study will be two 6 weeks periods during which each subject will receive Cystone or placebo in random order (with a one-week wash out between 6 week treatment periods). The remaining 46 weeks, each subject will receive Cystone. End points are changes in urinary chemistries and stone burden by Computerized Tomography (CT) scanning.

Condition or Disease	Intervention/Treatment	Phase
Cystinuria; Nephrolithiasis, Calcium Oxalate	Drug: Cystone; Drug: Sugar Pill (Placebo)	Phase 1/Phase 2

Detailed Description

Cystone will be used in proven cystine and calcium stone forming adults who are not pregnant. Subjects must have a measurable stone by CT. The first phase is a double blind, randomized, placebo controlled cross-over of Cystone and placebo for 6 weeks each separated by a 1 week washout. Entry, 6 and 12 week 24 hour urine supersaturations or cystine, pH and sodium determinations will be collected. Then all patients enter an open label phase of 46 weeks, ensuring a 52-week total exposure to Cystone during the 59 week study. Baseline and 1 year stone quantification CT scans will be performed. End points will be changes in urine chemistry/supersaturation and stone burden. Stone burden was measured by CT, quantitatively for stone density and volume. All CT images were also reviewed in a blinded fashion by a radiologist to score each kidney as increased, no change or decreased stone burden.

Statistics and Randomization: Randomization was accomplished using a table provided by the department of statistics to the study coordinator who was blinded as to whether the patients received placebo or Cystone®. Biochemical and supersaturation results were analyzed via a matched pair analysis using the JMP software package (SAS Instituted, Inc.); P values < 0.05 were deemed significant.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Cystone for Treatment of Nephrolithiasis
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cystone then sugar pill Subject will take Cystone for 6 weeks, then have a 1 week wash out period followed by the sugar pill for another 6 weeks	Drug: Cystone; Participants will take 2 pills, 2 times a day. Each tablet of Cystone contains: Shilapushpha (Didymocarpus pedicellata) 130 mg, Pasanabheda (Saxifraga ligulata Syn. Bergenia ligulata/cilata) 98 mg, Indian madder/ Manjishtha (Rubia cordifolia) 32 mg, Umbrella's edge/ Nagarmusta (Cyperus scariosus) 32 mg, Prickly chaff flower/ Apamarga (Achyranthes aspera) 32 mg, Sedge/ Gojiha (Onosma bracteatum) 32 mg, Purple fleabane/ Sahadeve (Veronoia Cinerea) 32 mg, Lime silicate calx/ Hajrul yahood Bhasma/ Badrashma bhasma) 32 mg, Shilajit 26 mg.; Other Names: Uricare ; Drug: Sugar Pill (Placebo); Participants will take 2 pills, 2 times a day for 6 weeks.
Placebo Comparator: Sugar pill then Cystone Subject will take sugar pill for 6 weeks, then a 1 week wash out followed by the Cystone for another 6 weeks	Drug: Cystone; Participants will take 2 pills, 2 times a day. Each tablet of Cystone contains: Shilapushpha (Didymocarpus pedicellata) 130 mg, Pasanabheda (Saxifraga ligulata Syn. Bergenia ligulata/cilata) 98 mg, Indian madder/ Manjishtha (Rubia cordifolia) 32 mg, Umbrella's edge/ Nagarmusta (Cyperus scariosus) 32 mg, Prickly chaff flower/ Apamarga (Achyranthes aspera) 32 mg, Sedge/ Gojiha (Onosma bracteatum) 32 mg, Purple fleabane/ Sahadeve (Veronoia Cinerea) 32 mg, Lime silicate calx/ Hajrul yahood Bhasma/ Badrashma bhasma) 32 mg, Shilajit 26 mg.; Other Names: Uricare ; Drug: Sugar Pill (Placebo); Participants will take 2 pills, 2 times a day for 6 weeks.
Experimental: Open-label Cystone All subjects will receive Cystone for 46 weeks in the open-label period.	Drug: Cystone; Participants will take 2 pills, 2 times a day. Each tablet of Cystone contains: Shilapushpha (Didymocarpus pedicellata) 130 mg, Pasanabheda (Saxifraga ligulata Syn. Bergenia ligulata/cilata) 98 mg, Indian madder/ Manjishtha (Rubia cordifolia) 32 mg, Umbrella's edge/ Nagarmusta (Cyperus scariosus) 32 mg, Prickly chaff flower/ Apamarga (Achyranthes aspera) 32 mg, Sedge/ Gojiha (Onosma bracteatum) 32 mg, Purple fleabane/ Sahadeve (Veronoia Cinerea) 32 mg, Lime silicate calx/ Hajrul yahood Bhasma/ Badrashma bhasma) 32 mg, Shilajit 26 mg.; Other Names: Uricare

Outcome Measures

Primary Outcome Measures

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

   Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.

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

   Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.

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

   Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.

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

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

   Agatston results are a measure of calcium typically used for measuring coronary artery calcification.

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

   Measurement of kidney stone volume in cubic millimeters.

Secondary Outcome Measures

1. Change in Stone Burden as Assessed by Radiologist at One Year [Baseline, approximately 52 weeks after baseline]

   Stone burden will be quantitated using the stone quantification protocol currently available at Mayo that quantitates kidney stones both by volume and by density measured in Agatston units.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Written informed consent In the cystine arm, all patients will have the diagnosis of cystinuria, made on the basis of a 24-hour urine cystine containing more than 1500 umol of cystine, or a stone compositional analysis of cystine

• Presence of an existing cystine stone in one or both kidneys In the calcium arm, all patients will have a history of a calcium stone as determined by laboratory analysis.

• Medically effective birth control if fertile female

• Able to comply with protocol

Exclusion Criteria:

• Pregnant

• Subjects under age 18 years

• Obstructing stones

• Urinary Tract Infection that cannot be cleared with single course of antibiotic

• Subjects who decline to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Mayo Clinic
• Himalaya Herbal Healthcare
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Stephen B. Erickson, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Stephen B. Erickson, M.D., PI, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT00381849
• Other Study ID Numbers: 2115-05; P50DK083007
• First Posted: Sep 28, 2006
• Last Update Posted: Feb 4, 2016
• Last Verified: Jan 1, 2016

• Keywords provided by Stephen B. Erickson, M.D., PI, Mayo Clinic: Cystone; Uricare; Computerized tomography; Kidney calculi; Supersaturation; Nephrolithiasis; Quantitative CT
• Additional relevant MeSH terms: Nephrolithiasis; Kidney Calculi; Cystinuria

Study Results

Participant Flow

Recruitment Details	Patients with recurring and analytically confirmed kidney stones were recruited from the Mayo Stone Clinic in Rochester, MN.

Arm/Group Title	Calcium Stone Subjects	Cystine Stone Subjects
Arm/Group Description	Subjects with confirmed calcium kidney stone(s)	Subjects with confirmed cystine kidney stone(s)
Period Title: First Intervention
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	10	10
COMPLETED	10	9
NOT COMPLETED	0	1
Period Title: First Intervention
STARTED	10	9
COMPLETED	10	9
NOT COMPLETED	0	0
Period Title: First Intervention
STARTED	10	9
COMPLETED	10	9
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Calcium Stone Subjects	Cystine Stone Subjects	Total
Arm/Group Description	Subjects with confirmed calcium kidney stone(s)	Subjects with confirmed cystine kidney stone(s)	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	8 80%	9 90%	17 85%
>=65 years	2 20%	1 10%	3 15%
Sex: Female, Male (Count of Participants)
Female	6 60%	4 40%	10 50%
Male	4 40%	6 60%	10 50%
Region of Enrollment (participants) [Number]
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	24 Hour Urine Supersaturation of Calcium Oxalate (CaOx)
Description	Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
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

Outcome Measure Data

Analysis Population Description

CaOx was not analyzed for the Cystine Stone subjects.

Arm/Group Title	Calcium Stone Subjects	Cystine Stone Subjects
Arm/Group Description	Subjects with confirmed calcium kidney stone(s)	Subjects with confirmed cystine kidney stone(s)
Measure Participants	10	0
CaOx at Baseline	1.83 (0.28)
CaOx after placebo (6 wks)	1.83 (0.42)
CaOx after Cystone (6 wks)	1.87 (0.43)
CaOx at end of Cystone (46 weeks)	1.78 (0.47)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calcium Stone Subjects
	Comments	Paired t test for supersaturation of CaOx between baseline and after 6 weeks' treatment on placebo.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments
	Method	t-test, 1 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Calcium Stone Subjects
	Comments	Paired t test for supersaturation of CaOx between baseline and after 6 weeks' treatment on cystone.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.23
	Comments
	Method	t-test, 1 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Calcium Stone Subjects
	Comments	Paired t test for supersaturation of CaOx between six weeks' treatment on cystone and 6 weeks' treatment on placebo.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.41
	Comments
	Method	t-test, 1 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Calcium Stone Subjects
	Comments	Paired t test for supersaturation of CaOx between baseline and after 46 weeks' treatment on cystone.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.32
	Comments
	Method	t-test, 1 sided
	Comments

2. Primary Outcome

Title	24 Hour Urine Supersaturation of Calcium Phosphate (Brushite)
Description	Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
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

Outcome Measure Data

Analysis Population Description

Brushite was not analyzed for the Cystine Stone subjects.

Arm/Group Title	Calcium Stone Subjects	Cystine Stone Subjects
Arm/Group Description	Subjects with confirmed calcium kidney stone(s)	Subjects with confirmed cystine kidney stone(s)
Measure Participants	10	0
Brushite at Baseline	0.35 (1.04)
Brushite after placebo (6 wks)	0.73 (0.83)
Brushite after Cystone (6 wks)	0.38 (0.98)
Brushite at end of Cystone (46 weeks)	0.09 (1.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calcium Stone Subjects
	Comments	Paired t test for supersaturation of Brushite between baseline and after 6 weeks' treatment on placebo.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.49
	Comments
	Method	t-test, 1 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Calcium Stone Subjects
	Comments	Paired t test for supersaturation of Brushite between baseline and after 6 weeks' treatment on cystone.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.64
	Comments
	Method	t-test, 1 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Calcium Stone Subjects
	Comments	Paired t test for supersaturation of Brushite between six weeks' treatment on cystone and 6 weeks' treatment on placebo.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.72
	Comments
	Method	t-test, 1 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Calcium Stone Subjects
	Comments	Paired t test for supersaturation of Brushite between baseline and after 46 weeks' treatment on cystone.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.84
	Comments
	Method	t-test, 1 sided
	Comments

3. Primary Outcome

Title	24 Hour Urine Supersaturation of Calcium Phosphate (Hydroxyapatite)
Description	Urine is often supersaturated, which favors precipitation of crystalline phases such as calcium oxalate. However, crystals do not always form in supersaturated urine because supersaturation is balanced by crystallization inhibitors that are also present. Supersaturation is calculated by measuring the concentration of all the ions that can interact. Once these concentrations are known, a computer program can calculate the theoretical supersaturation with respect to the important crystalline phases, eg, calcium oxalate.
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

Outcome Measure Data

Analysis Population Description

Hydroxyapatite was not analyzed for the Cystine Stone subjects.

Arm/Group Title	Calcium Stone Subjects	Cystine Stone Subjects
Arm/Group Description	Subjects with confirmed calcium kidney stone(s)	Subjects with confirmed cystine kidney stone(s)
Measure Participants	10	0
Hydroxyapatite at Baseline	4.25 (2.02)
Hydroxyapatite after placebo (6 wks)	5.03 (1.23)
Hydroxyapatite after Cystone (6 wks)	4.65 (1.86)
Hydroxyapatite at end of Cystone (46 weeks)	4.09 (2.06)

4. Secondary Outcome

Title	Change in Stone Burden as Assessed by Radiologist at One Year
Description	Stone burden will be quantitated using the stone quantification protocol currently available at Mayo that quantitates kidney stones both by volume and by density measured in Agatston units.
Time Frame	Baseline, approximately 52 weeks after baseline

Outcome Measure Data

Analysis Population Description

One subject in the Calcium group was excluded from the CT analysis because of bilateral stone removal surgery during the study.

Arm/Group Title	Calcium Stone Subjects	Cystine Stone Subjects
Arm/Group Description	Subjects with confirmed calcium kidney stone(s)	Subjects with confirmed cystine kidney stone(s)
Measure Participants	9	9
Right kidney no change in stone burden	6	7
Right kidney stone burden increased	2	2
Right kidney stone burden decreased	1	0
Left kidney no change in stone burden	2	2
Left kidney stone burden increased	6	5
Left kidney stone burden decreased	1	2

5. Primary Outcome

Title	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

Outcome Measure Data

Analysis Population Description

Cystine excretion was not applicable to the Calcium Stone subjects.

Arm/Group Title	Calcium Stone Subjects	Cystine Stone Subjects
Arm/Group Description	Subjects with confirmed calcium kidney stone(s)	Subjects with confirmed cystine kidney stone(s)
Measure Participants	0	10
Cystine at Baseline	2770 (947)
Cystine after placebo (6 wks)	3183 (1898)
Cystine after Cystone (6 wks)	2948 (2021)
Cystine at end of Cystone (46 weeks)	4140 (2398)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cystine Stone Subjects
	Comments	Paired t test for urinary cystine between baseline and after 6 weeks' treatment on placebo.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.69
	Comments
	Method	t-test, 1 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cystine Stone Subjects
	Comments	Paired t test for urinary cystine between baseline and after 6 weeks' treatment on cystone.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.25
	Comments
	Method	t-test, 1 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cystine Stone Subjects
	Comments	Paired t test for urinary cystine between six weeks' treatment on cystone and 6 weeks' treatment on placebo.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.15
	Comments
	Method	t-test, 1 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cystine Stone Subjects
	Comments	Paired t test for urinary cystine between baseline and after 46 weeks' treatment on cystone.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.20
	Comments
	Method	t-test, 1 sided
	Comments

6. Primary Outcome

Title	Stone Density as Measured by Agatston Score Via Computerized Tomography
Description	Agatston results are a measure of calcium typically used for measuring coronary artery calcification.
Time Frame	Baseline, approximately 52 weeks after baseline

Outcome Measure Data

Analysis Population Description

One subject was excluded from CT analysis because of bilateral stone removal surgery during the study

Arm/Group Title	Calcium Stone Subjects	Cystine Stone Subjects
Arm/Group Description	Subjects with confirmed calcium kidney stone(s)	Subjects with confirmed cystine kidney stone(s)
Measure Participants	9	10
Baseline Right Kidney Agatston Score	49.75 (60.24)	2,107 (4,417)
52 week Right Kidney Agatston Score	56.13 (74.23)	2,183 (4,157)
Baseline Left Kidney Agatston Score	166.13 (143.16)	383 (560)
52 week Left Kidney Agatston Score	247.71 (371.46)	1,801 (2,741)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calcium Stone Subjects
	Comments	Right Kidney Stone Density; P-value comparing one year to baseline
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.85
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Calcium Stone Subjects
	Comments	Left Kidney Stone Density; P-value comparing one year to baseline
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.63
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cystine Stone Subjects
	Comments	Right Kidney Stone Density; P-value comparing one year to baseline
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.97
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cystine Stone Subjects
	Comments	Left Kidney Stone Density; P-value comparing one year to baseline
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.15
	Comments
	Method	t-test, 2 sided
	Comments

7. Primary Outcome

Title	Volume of Kidney Stones as Measured on Computerized Tomography
Description	Measurement of kidney stone volume in cubic millimeters.
Time Frame	Baseline, approximately 52 weeks after baseline

Outcome Measure Data

Analysis Population Description

One subject was excluded from CT analysis because of bilateral stone removal surgery during the study.

Arm/Group Title	Calcium Stone Subjects	Cystine Stone Subjects
Arm/Group Description	Subjects with confirmed calcium kidney stone(s)	Subjects with confirmed cystine kidney stone(s)
Measure Participants	9	10
Baseline Right Kidney Stone Volume	45.5 (52.03)	1,602 (3,335)
52 Week Right Kidney Stone Volume	52.75 (66.44)	1,677 (3,139)
Baseline Left Kidney Stone Volume	141.25 (198.98)	301 (422)
52 Week Left Kidney Stone Volume	174.25 (265.73)	2,064 (688)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Calcium Stone Subjects
	Comments	Right Kidney Stone Volume; P-value comparing one year to baseline
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.81
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Calcium Stone Subjects
	Comments	Left Kidney Stone Volume; P-value comparing one year to baseline
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.78
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cystine Stone Subjects
	Comments	Right Kidney Stone Volume; P-value comparing one year to baseline
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.96
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cystine Stone Subjects
	Comments	Left Kidney Stone Volume; P-value comparing one year to baseline
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.13
	Comments
	Method	t-test, 2 sided
	Comments

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	Subject self reported any adverse effects.
Arm/Group Title	Calcium Stone Subjects		Cystine Stone Subjects
Arm/Group Description	Subjects with confirmed calcium kidney stone(s)		Subjects with confirmed cystine kidney stone(s)
All Cause Mortality
	Calcium Stone Subjects		Cystine Stone Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Calcium Stone Subjects		Cystine Stone Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Calcium Stone Subjects		Cystine Stone Subjects
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

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.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.