NCT01338714

Brief Summary

The aim of the study is to examine whether the compound herbal formula (RHD-1) is effective on HBV Carrier With Abnormal Liver Function.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2011

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2011

Completed
12 days until next milestone

Study Start

First participant enrolled

May 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 7, 2014

Status Verified

May 1, 2014

Enrollment Period

1.1 years

First QC Date

April 18, 2011

Last Update Submit

May 6, 2014

Conditions

Liver Dysfunction

Keywords

HBV carrierHBV DNA titleChinese MedicineLiver functionRHD-1

Outcome Measures

Primary Outcomes (1)

  • the % change of HBV DNA title

    6 weeks

Secondary Outcomes (1)

  • the % change of GPT

    6 weeks

Study Arms (2)

A foumula

EXPERIMENTAL

Compound Herbal Formula (RHD-1)

Other: Compound Herbal Formula (RHD-1)

B formula

PLACEBO COMPARATOR

dilute Compound Herbal Formula

Other: dilute RHD-1

Interventions

Compound Herbal Formula (RHD-1)OTHER

100 ml/per day

Also known as: Chinese herbal medicine
A foumula
dilute RHD-1OTHER

100 ml/per day

Also known as: Chinese herbal medicine dilute
B formula

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \< GPT \<200 HBV carrier Age: 18-65 yrs old

You may not qualify if:

  • Creatinine \>2.0 mg/dL Total bilirubin \> 2.0mg/dL Not suitable patients diagnosis by physician in charge.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei City Hospital

Taipei, Taiwan, 886, Taiwan

Location

Related Publications (3)

  • Hsu CH, Hwang KC, Chiang YH, Chou P. The mushroom Agaricus blazei Murill extract normalizes liver function in patients with chronic hepatitis B. J Altern Complement Med. 2008 Apr;14(3):299-301. doi: 10.1089/acm.2006.6344.

    PMID: 18370584BACKGROUND

  • Chu CJ, Hussain M, Lok AS. Quantitative serum HBV DNA levels during different stages of chronic hepatitis B infection. Hepatology. 2002 Dec;36(6):1408-15. doi: 10.1053/jhep.2002.36949.

    PMID: 12447866BACKGROUND

  • Lee CJ, Cheng CH, Li YH, Liu CY, Hsu CH. A Chinese medicine, Kuan-Sin-Yin decoction, improves liver function in hepatitis B virus carriers: a randomized, controlled study. J Altern Complement Med. 2013 Dec;19(12):964-9. doi: 10.1089/acm.2013.0136. Epub 2013 Jul 17.

    PMID: 23863086DERIVED

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president

Study Record Dates

First Submitted

April 18, 2011

First Posted

April 19, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2012

Study Completion

September 1, 2012

Last Updated

May 7, 2014

Record last verified: 2014-05

Locations

TW(1)