A Single-Arm Study Evaluating the Efficacy of Liquid Acupuncture Therapeutics in Chronic Hepatitis B (CHB)
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|ClinicalTrials.gov Identifier: NCT00815464|
Recruitment Status : Unknown
Verified December 2008 by Yu Medical Garden.
Recruitment status was: Not yet recruiting
First Posted : December 30, 2008
Last Update Posted : December 30, 2008
The purpose of this study is to assess that Liquid Acupuncture(Herb Acupoints Injection) Therapeutics could achieve permanent efficacy response in Chronic Hepatitis B.
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatitis B, Chronic Liver Diseases Virus Diseases Hepatitis Diffuse Hepatic Disease||Device: Liquid Acupuncture (Herb Acupoint Injection)||Not Applicable|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy Study of Liquid Acupuncture(Herb Acupoint Injection) Therapeutics in Chronic Hepatitis B(CHB) Based on Patients' Individual Condition|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||September 2009|
|Estimated Study Completion Date :||March 2010|
Experimental: Antiviral Therapy
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.
Device: Liquid Acupuncture (Herb Acupoint Injection)
Each 4 weeks per one circle.The first 3 weeks for treatment practice(one per week)and the last week for test collection.
Other Name: Antiviral Agents
- 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 ]
- HBsAg titer will decrease continually up to loss after cessation of the treatment. [ Time Frame: one year later ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00815464
|Contact: Ke Heng Yu||+86 firstname.lastname@example.org|
|Contact: Ya Hua Yu||+86 email@example.com|
|Principal Investigator:||Ke Heng Yu||Yu Medical Garden|