Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00018

2 Trial Registration Date

2005-09-05

i Registration Status

Prospective

3 Secondary IDs

4 Source(s) of Funding

Hepatitis Research Fund

5 Primary Sponsor

Sundise

6 Secondary Sponsor

Function

Please specify

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

i Name

Angel Chim

ii Address

iii Phone

Room 36, 2/F, LSK Specialist Clinic South Wing, PWH; Tel: 2632 4205; e-mail: angelchim@cuhk.edu.hk

iv Email

e-mail

v Affiliation

vi Country

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

i Name

Dr Henry LY Chan

ii Address

iii Phone

9/F Clinical Science Building, PWH; Tel: 2632 3307; e-mail: hlychan@cuhk.edu.hk

iv Email

e-mail

v Affiliation

vi Country

9 Official Scientific Title of the Study

A Pilot Study of Formula Pinggan in the Treatment of Liver Cirrhosis

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2005-07-19

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Liver cirrhosis

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Formula Pinggan 1.6g (i.e. 2 x 0.8 gm tablet) three times daily

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

24 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

-

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: age 18-70; liver cirrhosis of various etiology with MELD score >10; evidence of liver cirrhosis prior to screening documented by evidence of cirrhosis by previous liver biopsy prior to screening, evidence of cirrhosis by ultrasound, CT scan or MRI, or evidence of portal hypertension by endoscopic oesophageal varices, ascites, hypersplenism; Inactive liver disease with ALT < 5x upper limit of normal (<290 IU/l). Exclusion: history or presence of hepatocellular carcinoma; presence of grade 3 or 4 hepatic encephalopathy; serious medical or psychiatric illnesses; active alcohol or substance abuse; pregnancy, lactation or refusal to use safe contraception methods among female of reproductive age; concomitant use of interferon, anti-viral agents, corticosteroid or immunosuppressive agents; previous use or allergy to Formula Pinggan; serious laboratory abnormality (serum bilirubin > 51 umol/l; serum albumin < 25 g/l, serum creatinine > 1.5x ULN (168 umol/l), hemoglobin < 9.0 g/dl for men and < 8.0 g/dl for women)

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Uncontrolled

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2005-09-06

21 Target Sample Size

11

22 Recruitment Status

Recruiting

23 Primary Outcome

Improvement in mean MELD score among patients on Formula Pinggan

24 Secondary Outcome

1. Improvement in Child-Pugh score. 2. Proportion of patients with improved MELD and Child-Pugh scores. 3. Cirrhotic complications including bleeding varices, spontaneous bacterial peritonitis, hepatic encephalopathy. 4. Mortality. 5. Safety.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-03-02

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

None

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Trial History Detail on 2005-09-05