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Trial History Detail on 2011-03-02

CUHK_CCT00018

2005-09-05

Prospective

-

Hepatitis Research Fund

Sundise

-

Angel Chim

Room 36, 2/F, LSK Specialist Clinic South Wing, PWH;

Tel: 2632 4205;

e-mail e-mail: angelchim@cuhk.edu.hk

The Chinese University of Hong Kong

Dr Henry LY Chan

9/F Clinical Science Building, PWH;

Tel: 2632 3307;

e-mail e-mail: hlychan@cuhk.edu.hk

The Chinese University of Hong Kong

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

-

-

Hong Kong

Yes

2005-07-19

Liver cirrhosis

Drug

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

24 weeks

-

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)

18

65

Both Male and Female

Interventional

Non-randomized

Uncontrolled

Open label

Single group

2005-09-06

11

Complete

Improvement in mean MELD score among patients on Formula Pinggan

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.

No

2011-03-02

ChiCTR-TNRC-09000624

2010-05-04


Yes

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