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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard CMF | Active Comparator | Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir).
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| Advanced CMF | Experimental | 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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard - Yinchengao Decoction plus Ganlu Detoxification Pill | Drug | Yinchengao Decoction plus Ganlu Detoxification Pill is one Chinese Medicine Formula for the TCM syndrome: Damp-heat blocking middle jiao. |
| Measure | Description | Time Frame |
|---|---|---|
| Traditional Chinese Medicine symptom scale | Change of TCM symptom scale between baseline and sixth months of treatment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianmei Hao, MD | Contact | 86-29-89626651 | 12479088@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xi'an Traditional Medicine Hospital | Recruiting | Xi'an | Shaanxi | China |
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| Pure Entecavir or Tenofovir | Experimental | Use an anti-virus western drug alone (such as Entecavir or Tenofovir). |
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| Entecavir or Tenofovir | Drug | Western drug for anti-HBV such as Entecavir and Tenofovir |
|
| Standard - Ge Xia Zhu Yu Decoction | Drug | Ge Xia Zhu Yu Decoction is one Chinese Medicine Formula for the TCM syndrome: internal blood stasis. |
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| Advanced - Supplemented Taohong Huazhuo Decoction | Drug | 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. |
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| Standard - Chaihu Shugan San | Drug | Chaihu Shugan San is one Chinese Medicine Formula for the TCM syndrome: Liver depression and qi stagnation. |
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| Advanced - Soothe the liver and regulate qi Decoction | Drug | 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. |
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| Standard - Xiaoyao powder | Drug | Xiaoyao powder is one Chinese Medicine Formula for the TCM syndrome: Stagnation of liver qi and spleen deficiency. |
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| Advanced - Supplemented Ganbi Decoction | Drug | 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. |
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| Standard - Yiguan Decoction | Drug | Yiguan Decoction is one Chinese Medicine Formula for the TCM syndrome: Yin deficiency of liver and kidney. |
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| Advanced - Supplemented Zimu Dan | Drug | 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. |
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| Standard - Fuzilizhong Decoction plus Jinkui Shenqi Bolus | Drug | Fuzilizhong Decoction plus Jinkui Shenqi Bolus is one Chinese Medicine Formula for the TCM syndrome: Yang deficiency of spleen and kidney. |
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| Advanced - Guifu Erxian Decoction | Drug | 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. |
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| Advanced - Supplemented Ganji Decoction | Drug | 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. |
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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 |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C413685 | entecavir |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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