The Effect of Compound Herbal Formula (RHD-1) on HBV Carrier With Abnormal Liver Function

NCT ID: NCT01338714

Last Updated: 2014-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-09-30

Brief Summary

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

Detailed Description

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% change HBV DNA title and liver function.

Conditions

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Liver Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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A foumula

Compound Herbal Formula (RHD-1)

Group Type EXPERIMENTAL

Compound Herbal Formula (RHD-1)

Intervention Type OTHER

100 ml/per day

B formula

dilute Compound Herbal Formula

Group Type PLACEBO_COMPARATOR

dilute RHD-1

Intervention Type OTHER

100 ml/per day

Interventions

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Compound Herbal Formula (RHD-1)

100 ml/per day

Intervention Type OTHER

dilute RHD-1

100 ml/per day

Intervention Type OTHER

Other Intervention Names

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Chinese herbal medicine Chinese herbal medicine dilute

Eligibility Criteria

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Inclusion Criteria

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

Exclusion:

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Yang Ming Chiao Tung University

OTHER

Sponsor Role collaborator

Taipei City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Chung-Hua Hsu

vice president

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taipei City Hospital

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 18370584 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12447866 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23863086 (View on PubMed)

Other Identifiers

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100-00-62-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

100001-62-010

Identifier Type: -

Identifier Source: org_study_id

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