Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00163

2 Trial Registration Date

2008-04-22

i Registration Status

Prospective

3 Secondary IDs

Nil

4 Source(s) of Funding

Nil

5 Primary Sponsor

Division of Urology, Department of Surgery, The Chinese University of Hong Kong

6 Secondary Sponsor

NA

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Ng Chi Fai

ii Address

iii Phone

Phone: 26322625, Fax: 26377974,

iv Email

e-mail: ngcf@surgery.cuhk.edu.hk

v Affiliation

Associate Professor, Department of Surgery

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Ng Chi Fai

ii Address

iii Phone

Phone: 26322625, Fax: 26377974,

iv Email

e-mail: ngcf@surgery.cuhk.edu.hk

v Affiliation

Associate Professor, Department of Surgery

vi Country

9 Official Scientific Title of the Study

Effect of Shi Wei on urine biochemistry and crystallization properties in renal stone formers

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Nil

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2007-10-04

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Renal stone

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Shi Wei

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

7 days

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion criteria 1.Male patients (age 30-70 years, body weight 55-80 kg) either have recurrent stone disease or new stone former. 2.They are idiopathic stone-formers (includes calcium oxalate, calcium phosphate & uric acid) that is, without underlying urological anomalies such as, medullar sponge kidney, gastrointestinal disorders, hyperparathyroidism or other hypercalcemic disorders, sarcoidosis, Paget's disease, renal tubular acidosis, primary hyperoxaluria, gout or other hyperuricemic disorders, or drugs inducing nephrolithiasis.

ii Exclusion Criteria

Exclusion criteria 1.Patient with active urinary infection, obstruction or hematuria during the study period 2.change of any medication for other medical diseases during the study period 3.Abnormal renal function (Serum creatinine levels that are more than 1.5 times upper limit of normal range, UML.) 4.abnormal liver function (ALT > 1.5 x UNL associated with alkaline phosphatase > 2.5 x UNL are not eligible for the study)

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2008-05-02

21 Target Sample Size

100

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

The effects of Shi Wei on the biochemistry of early morning urine in idiopathic calcium renal stone formers.

24 Secondary Outcome

The effects of Shi Wei on quantity, size and aggregation of stone crystals in vivo by image analysis.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2009-11-20

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

nil

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Trial History Detail on 2009-11-19