The Study of Two Different Chinese Traditional Medicine Treatment on Chronic Hepatitis B

Study Overview
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Brief Summary
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Although the incidence of Hepatitis B has been decreased a lot recently years, there are still quite a few chronic hepatitis B patients in China. The anti-virus drugs of western medicine such as Entecavir and Tenofovir have been proved effective on decreasing the serum hepatitis B virus (HBV) level, on the other hand, Chinese materia medica showed effective on TCM syndromes of chronic hepatitis B (CHB) such as hypochondriac pain, jaundice and abdominal mass. Besides, the hepatic fibrosis could be delayed after the appropriate treatment of TCM. This study is a multicenter, randomized, open label, parallel group clinical trial to evaluate the efficacy of two different traditional Chinese medicine (TCM) herbal treatment on chronic hepatitis B.

Official Title
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Efficacy Comparison Between Two Kind of Chinese Herbal Formulas on Traditional Chinese Medicine Syndromes Among Chronic Hepatitis Patients

Conditions
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Hepatitis B， Chronic

Intervention / Treatment
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* Drug: Standard - Yinchengao Decoction plus Ganlu Detoxification Pill
* Drug: Entecavir or Tenofovir
* Drug: Standard - Ge Xia Zhu Yu Decoction
* Drug: Advanced - Supplemented Taohong Huazhuo Decoction
* Drug: Standard - Chaihu Shugan San
* Drug: Advanced - Soothe the liver and regulate qi Decoction
* Drug: Standard - Xiaoyao powder
* Drug: Advanced - Supplemented Ganbi Decoction
* Drug: Standard - Yiguan Decoction
* Drug: Advanced - Supplemented Zimu Dan
* Drug: Standard - Fuzilizhong Decoction plus Jinkui Shenqi Bolus
* Drug: Advanced - Guifu Erxian Decoction
* Drug: Advanced - Supplemented Ganji Decoction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18<=age at treatment<=65 years old Was diagnosed as chronic hepatitis B (ICD10:K73.901) and one of the following Chinese syndromes: hypochondriac pain (TCD:BNG010), jaundice(TCD:BNG020) or abdominal mass (TCD:BNG040). Exclusion Criteria: Combined with other virus hepatitis or alcoholic hepatitis Combined with autoimmune disease Combined with liver cancer or cirrhosis Combined with severe hepatitis with or without complications Combined with unstable cardio-cerebrovascular disease Combined with severe lung, kidney, endocrine system, nervous system and hematological system diseases Combined with Tuberculosis Chronic hepatitis patients with ongoing INF treatment Woman with pregnancy or breasting feeding Mental disorder and can not express self clearly Cannot speak Chinese Allergic constitution or allergy to multiple drugs Refuse to enroll into the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard CMF<br>Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir). Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency. Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis | Drug: Standard - Yinchengao Decoction plus Ganlu Detoxification Pill<br>* Yinchengao Decoction plus Ganlu Detoxification Pill is one Chinese Medicine Formula for the TCM syndrome: Damp-heat blocking middle jiao.<br>Drug: Entecavir or Tenofovir<br>* Western drug for anti-HBV such as Entecavir and Tenofovir<br>Drug: Standard - Ge Xia Zhu Yu Decoction<br>* Ge Xia Zhu Yu Decoction is one Chinese Medicine Formula for the TCM syndrome: internal blood stasis.<br>Drug: Standard - Chaihu Shugan San<br>* Chaihu Shugan San is one Chinese Medicine Formula for the TCM syndrome: Liver depression and qi stagnation.<br>Drug: Standard - Xiaoyao powder<br>* Xiaoyao powder is one Chinese Medicine Formula for the TCM syndrome: Stagnation of liver qi and spleen deficiency.<br>Drug: Standard - Yiguan Decoction<br>* Yiguan Decoction is one Chinese Medicine Formula for the TCM syndrome: Yin deficiency of liver and kidney.<br>Drug: Standard - Fuzilizhong Decoction plus Jinkui Shenqi Bolus<br>* Fuzilizhong Decoction plus Jinkui Shenqi Bolus is one Chinese Medicine Formula for the TCM syndrome: Yang deficiency of spleen and kidney.<br>|
| Experimental: Advanced CMF<br>Advanced TCM formulas for corresponding TCM syndromes provided by famous TCM doctors who were national wide known in China, plus an anti-virus western drugs (such as Entecavir or Tenofovir). Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency. Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis | Drug: Entecavir or Tenofovir<br>* Western drug for anti-HBV such as Entecavir and Tenofovir<br>Drug: Advanced - Supplemented Taohong Huazhuo Decoction<br>* Supplemented Taohong Huazhuo Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Damp-heat blocking middle jiao.<br>Drug: Advanced - Soothe the liver and regulate qi Decoction<br>* Soothe the liver and regulate qi Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Liver depression and qi stagnation.<br>Drug: Advanced - Supplemented Ganbi Decoction<br>* Supplemented Ganbi Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Stagnation of liver qi and spleen deficiency.<br>Drug: Advanced - Supplemented Zimu Dan<br>* Supplemented Zimu Dan is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Yin deficiency of liver and kidney.<br>Drug: Advanced - Guifu Erxian Decoction<br>* Guifu Erxian Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Yang deficiency of spleen and kidney.<br>Drug: Advanced - Supplemented Ganji Decoction<br>* Supplemented Ganji Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: internal blood stasis.<br>|
| Experimental: Pure Entecavir or Tenofovir<br>Use an anti-virus western drug alone (such as Entecavir or Tenofovir). | Drug: Entecavir or Tenofovir<br>* Western drug for anti-HBV such as Entecavir and Tenofovir<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Traditional Chinese Medicine symptom scale |  | Change of TCM symptom scale between baseline and sixth months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of liver fibrosis | Use change of FibroScan measurement of liver between baseline and 6th months of treatment to express the change of liver fibrosis | Chnage of liver fibrosis between baseline and 6th months of treatment | 
| Overall effectiveness of treatment defined by the guidelines for prevention and treatment of chronic hepatitis B | Treatments were completely effective, partially effective or not effective after treatment. Complete effective: Alanine aminotransferase normal, HBV DNA, HBeAg and HBsAg are negative Partially effective: Alanine aminotransferase normal, HBV DNA, HBeAg are negative and HBsAg stay positive Not effective: Did not reach any one of what are listed above. | Overall effectiveness of treatment between baseline and 6th months of treatment |