Other Clinical Trial - A Single-Arm Study Evaluating the Efficacy of

Status Not yet recruiting

Clinical Trial Summary

Study Purpose:

The purpose of this study is to assess that Liquid Acupuncture(Herb Acupoints Injection) Therapeutics could achieve permanent efficacy response in Chronic Hepatitis B.

Efficacy Assessment:

At cessation of the Treatment(about at 24 weeks)comparing Testing Data with the Normal Criteria and their individual baseline.Continue for monitoring the Status 1-5 years.

Data Analysis:

Each 4 weeks collecting Patients' testing data and fill a table.A summary table will be presented as frequency tables for categorical variables as number or percentage.

Clinical Trial Description

Inclusion Criteria & Outcome:

Documented chronic hepatitis B infection positive serum HBV-DNA 10^5 copies/mL & above.

Permanent efficacy response after whole treatment circle close(about 24 weeks,someone may be later than 24 weeks but within 48 weeks)

- HBeAg loss(if HBeAg positive)

- Liver Function normal(if Liver Function off normal)

- HBV DNA non-detectability (PCR <500 copies/ml)

- Image of chronic diffuse hepatic disease will recover up to normal if have.

- HBsAg titer will decrease continually up to loss after cessation of the treatment.

Treatment Procedure:

Patients will be involved in the study for up to 24-48 weeks from enrollment. There is no external sponsor, commercial sponsor nor governmental agency on this study. The study will be conducted only by Dr. Yu, Ke Heng,who is master of the Liquid Acupuncture(Herb Acupoint Injection)practice more than 30 years.About 30 subjects will be involved in the study overall. All the subjects can be filled up worldwide.

Patients will be required to rent apartment or house for staying at the city(Xiamen city,China preferred).Dr. Yu will go to the Patients' site for treatment practice weekly,each 4 weeks is one circle(the first 3 weeks for treatment practice and last week for Test collection).Appointed Hospitals for test must be certificated and qualified(Chang Gang Hospital preferred).Dr. Yu will explain the test results individually. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00815464
Study type	Interventional
Source	Yu Medical Garden
Contact	Ke Heng Yu
Phone	+86 13752305455
Email	hailinhospital@yahoo.com.cn
Status	Not yet recruiting
Phase	N/A
Start date	March 2009
Completion date	March 2010

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

A Single-Arm Study Evaluating the Efficacy of Liquid Acupuncture Therapeutics in Chronic Hepatitis B — CHB

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms