Hepatitis B, ChronicCHBNCT00815464
A Single-Arm Study Evaluating the Efficacy of Liquid Acupuncture Therapeutics in Chronic Hepatitis B
A study testing Liquid Acupuncture (Herb Acupoint Injection) in people with Hepatitis B, Chronic and Liver Diseases, run by Yu Medical Garden.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hepatitis B, Chronic, Liver Diseases, Virus Diseases
- What is being tested?
- Liquid Acupuncture (Herb Acupoint Injection)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female subjects aged 18-55 years inclusive.
- Documented chronic hepatitis B infection determined by the presence of serum HBsAg for at least 6 months.
- Serum HBV DNA ≥ 10^4 copies/mL(PRC).
- Use of interferon alfa, thymosin, or antiviral agents less than 1 year and not receive them more than 2 months. (If you expect to stop these agents but worry about the risk, you may ask us to help.)
- Agree not to participate in any other investigational trials or to undertake other HBV systemic antiviral regimens during participation in this study.
- Able to give written informed consent and comply with the requirements of the study.
Who cannot join
- Superinfection/Coinfection with hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV.
- Autoimmune hepatitis (antinuclear antibody titre > 1:160).
- Use of interferon alfa, thymosin, or antiviral agents more than 1 year.
- Pregnant or nursing.
- Any serious or active medical or psychiatric illnesses other than hepatitis B which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. This would include, may not limit to, renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, active infection or cancer.
- Clinical signs of decompensated liver disease at baseline. These may include but are not limited to:serum bilirubin > 2.5 mg/dL (≤ 43 µmol/L), prothrombin time > 2 second prolonged above ULN,serum albumin < 35g/L,history of ascites, variceal bleeding, or encephalopathy,Alanine aminotransferase (ALT) >10 times ULN at screening or history of acute exacerbation leading to transient decompensation.
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- Hepatocellular carcinoma as evidenced by one of the following:
- suspicious foci on ultrasound or radiological examination.
- where no positive ultrasound finding, but serum alpha-fetoprotein > 100ng/mL
- Active alcohol or drug abuse or history of alcohol or drug abuse considered by the investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results.
- Received hepatotoxic drugs (e.g., anabolic steroids, ketaconazole, itraconazole, isoniazid, rifampin, rifabutin) within 2 months prior to study screening or expected to receive these during the course of the study.
- Received nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cis-platinum, pentamidine etc.) or competitors of renal excretion (e.g., probenecid) within 2 months prior to study screening or the expectation that patient will receive any of these during the course of the study.
- Receiving systemic (intravenous or oral) steroids, immuno-suppressant therapies or chemotherapeutic agents within 2 months of study screening or expected to receive these agents during the course of the study.
- Neutrophile granulocyte count <1.0*10e9/L and Platelet count < 30*10e9/L.
- Inability to comply with study requirements.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy Study of Liquid Acupuncture(Herb Acupoint Injection) Therapeutics in Chronic Hepatitis B(CHB) Based on Patients' Individual Condition
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.
Read the detailed 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.
- Being tested
- Liquid Acupuncture (Herb Acupoint Injection)
- Keywords
- Chronic Hepatitis B, Liquid Acupuncture(Herb Acupoint Injection), Therapeutics, Herbalist, Acupoint
- Medical subject headings
- Hepatitis B, Chronic, Liver Diseases, Virus Diseases, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liquid Acupuncture (Herb Acupoint Injection)Device
Also called Antiviral Agents
Each 4 weeks per one circle.The first 3 weeks for treatment practice(one per week)and the last week for test collection.
| Study group | Role | What they receive |
|---|---|---|
| Antiviral Therapy | Experimental | Liquid Acupuncture(Herb Acupoints Injection) Therapeutics was researched and developed by Herbalist Yu Ru Lin in early of 1950s and used by Yu Medical Garden till now. It is an integrated therapeutics,according to individual condition, select the Acupoints(not limit to current used common acupoints) and proper herbs made individually.It is a special medical treatment conception, which theory is utilizing patients' condition, mobilizing their individual internal curability,therefore the final efficacy can be retrieved. Receives: Device: Liquid Acupuncture (Herb Acupoint Injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Permanent Efficacy response after whole treatment circle close(about 24-48 weeks): 1、HBeAg loss(if HBeAg positive) 2、HBV DNA non-detectability (PCR <500 copies/ml) 3、Liver function normal(If Liver function off normal)
Measured: 1-2 years
Secondary outcomes (1)
HBsAg titer will decrease continually up to loss after cessation of the treatment.
Measured: one year later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2008 (estimated)
- Study startMar 2009
- Primary completionSep 2009 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yu Medical Garden
- Sponsor type
- University, hospital or other
- Investigators
- Ke Heng Yu, Principal investigator, Yu Medical Garden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00815464
- Sponsor's protocol ID
- YMG-PR-001
- Acronym
- CHB
- Status last verified
- Dec 2008
- First submitted
- 29 Dec 2008
- Last updated
- 30 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Study of Liquid Acupuncture(Herb Acupoint Injection) Therapeutics in Chronic Hepatitis B(CHB) Based on Patients' Individual Condition
- ClinicalTrials.gov ID
- NCT00815464
- Acronym / sponsor ID
- CHB / YMG-PR-001
- Keywords
- Chronic Hepatitis B, Liquid Acupuncture(Herb Acupoint Injection), Therapeutics, Herbalist, Acupoint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Yu Medical GardenUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 30 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Antiviral Therapy | Experimental | Device: Liquid Acupuncture (Herb Acupoint Injection)Liquid Acupuncture(Herb Acupoints Injection) Therapeutics was researched and developed by Herbalist Yu Ru Lin in early of 1950s and used by Yu Medical Garden till now. It is an integrated therapeutics,according to individual condition, select the Acupoints(not limit to current used common acupoints) and proper herbs made individually.It is a special medical treatment conception, which theory is utilizing patients' condition, mobilizing their individual internal curability,therefore the final efficacy can be retrieved. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male or female subjects aged 18-55 years inclusive.
- Documented chronic hepatitis B infection determined by the presence of serum HBsAg for at least 6 months.
- Serum HBV DNA ≥ 10^4 copies/mL(PRC).
- Use of interferon alfa, thymosin, or antiviral agents less than 1 year and not receive them more than 2 months. (If you expect to stop these agents but worry about the risk, you may ask us to help.)
- Agree not to participate in any other investigational trials or to undertake other HBV systemic antiviral regimens during participation in this study.
Key exclusion criteria (15 listed)
- Superinfection/Coinfection with hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV.
- Autoimmune hepatitis (antinuclear antibody titre > 1:160).
- Use of interferon alfa, thymosin, or antiviral agents more than 1 year.
- Pregnant or nursing.
- Any serious or active medical or psychiatric illnesses other than hepatitis B which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. This would include, may not limit to, renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, active infection or cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Liquid Acupuncture (Herb Acupoint Injection)Also: Antiviral AgentsEach 4 weeks per one circle.The first 3 weeks for treatment practice(one per week)and the last week for test collection. | Device | Antiviral Therapy |
Primary outcome
Permanent Efficacy response after whole treatment circle close(about 24-48 weeks): 1、HBeAg loss(if HBeAg positive) 2、HBV DNA non-detectability (PCR <500 copies/ml) 3、Liver function normal(If Liver function off normal)
Time frame: 1-2 years
1 secondary outcome
HBsAg titer will decrease continually up to loss after cessation of the treatment.
Time frame: one year later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ke Heng Yu principal investigator
Yu Medical Garden
Questions about this trial
What is this clinical trial studying?
A study testing Liquid Acupuncture (Herb Acupoint Injection) in people with Hepatitis B, Chronic and Liver Diseases, run by Yu Medical Garden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ke Heng Yu (+86 13752305455, hailinhospital@yahoo.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Permanent Efficacy response after whole treatment circle close(about 24-48 weeks): 1、HBeAg loss(if HBeAg positive) 2、HBV DNA non-detectability (PCR <500 copies/ml) 3、Liver function normal(If Liver function off normal) (time frame: 1-2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2008.