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

Not Applicable

• Conditions: Hepatitis B， Chronic
• Interventions: Drug: Standard - Yinchengao Decoction plus Ganlu Detoxification Pill; Drug: Entecavir or Tenofovir; Drug: Advanced - Supplemented Taohong Huazhuo Decoction; Drug: Standard - Ge Xia Zhu Yu Decoction; Drug: Advanced - Soothe the liver and regulate qi Decoction; Drug: Standard - Chaihu Shugan San; Drug: Advanced - Supplemented Ganbi Decoction; Drug: Standard - Xiaoyao powder; Drug: Advanced - Supplemented Zimu Dan; Drug: Standard - Yiguan Decoction; Drug: Advanced - Guifu Erxian Decoction; Drug: Standard - Fuzilizhong Decoction plus Jinkui Shenqi Bolus; Drug: Advanced - Supplemented Ganji Decoction

• Registration Number: NCT03018821
• Lead Sponsor: Xi'an Traditional Medicine Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-01
• Study Start: 2017-01
• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-10
• Last Update Submitted: 2017-01-10
• Study First Posted: 2017-01-12
• Last Update Posted: 2017-01-12
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard CMF	Standard - Yinchengao Decoction plus Ganlu Detoxification Pill	Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir). 1. Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao 2. Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation 3. Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency. 4. Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney 5. Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney 6. Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis
Standard CMF	Standard - Ge Xia Zhu Yu Decoction	Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir). 1. Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao 2. Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation 3. Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency. 4. Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney 5. Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney 6. Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis
Standard CMF	Standard - Chaihu Shugan San	Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir). 1. Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao 2. Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation 3. Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency. 4. Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney 5. Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney 6. Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis
Standard CMF	Standard - Xiaoyao powder	Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir). 1. Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao 2. Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation 3. Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency. 4. Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney 5. Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney 6. Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis
Standard CMF	Standard - Yiguan Decoction	Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir). 1. Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao 2. Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation 3. Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency. 4. Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney 5. Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney 6. Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis
Standard CMF	Standard - Fuzilizhong Decoction plus Jinkui Shenqi Bolus	Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir). 1. Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao 2. Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation 3. Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency. 4. Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney 5. Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney 6. Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis
Advanced CMF	Advanced - Supplemented Taohong Huazhuo Decoction	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). 1. Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao 2. Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation 3. Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency. 4. Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney 5. Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney 6. Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis
Advanced CMF	Advanced - Soothe the liver and regulate qi Decoction	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). 1. Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao 2. Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation 3. Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency. 4. Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney 5. Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney 6. Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis
Advanced CMF	Advanced - Supplemented Ganbi Decoction	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). 1. Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao 2. Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation 3. Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency. 4. Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney 5. Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney 6. Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis
Advanced CMF	Advanced - Supplemented Zimu Dan	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). 1. Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao 2. Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation 3. Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency. 4. Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney 5. Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney 6. Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis
Advanced CMF	Advanced - Guifu Erxian Decoction	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). 1. Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao 2. Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation 3. Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency. 4. Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney 5. Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney 6. Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis
Advanced CMF	Advanced - Supplemented Ganji Decoction	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). 1. Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao 2. Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation 3. Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency. 4. Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney 5. Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney 6. Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis
Pure Entecavir or Tenofovir	Entecavir or Tenofovir	Use an anti-virus western drug alone (such as Entecavir or Tenofovir).
Advanced CMF	Entecavir or Tenofovir	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). 1. Taohong Huazhuo Decoction for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao 2. Soothe the liver and regulate qi Decoction for the TCM syndrome: Liver depression and qi stagnation 3. Supplemented Ganbi Decoction for the TCM syndrome: Stagnation of liver qi and spleen deficiency. 4. Supplemented Zimu Dan for the TCM syndrome: Yin deficiency of liver and kidney 5. Guifu Erxian Decoction for the TCM syndrome: Yang deficiency of spleen and kidney 6. Supplemented Ganji Decoction for the TCM syndrome: Internal blood stasis
Standard CMF	Entecavir or Tenofovir	Standard Chinese medical formulas (CMF) for the corresponding TCM syndromes, plus an anti-virus treatment of western drugs (such as Entecavir or Tenofovir). 1. Yinchengao Decoction plus Ganlu Detoxification Pill for the Traditional Chinese Medicine (TCM) syndrome: Damp-heat blocking middle jiao 2. Chaihu Shugan San for the TCM syndrome: Liver depression and qi stagnation 3. Xiaoyao powder for the TCM syndrome: Stagnation of liver qi and spleen deficiency. 4. Yiguan Decoction for the TCM syndrome: Yin deficiency of liver and kidney 5. Fuzilizhong Decoction plus Jinkui Shenqi Bolus for the TCM syndrome: Yang deficiency of spleen and kidney 6. Ge Xia Zhu Yu Decoction for the TCM syndrome: Internal blood stasis

Primary Outcome Measures

Name	Time	Method
Traditional Chinese Medicine symptom scale	Change of TCM symptom scale between baseline and sixth months of treatment

Secondary Outcome Measures

Name	Time	Method
The change of liver fibrosis	Chnage of liver fibrosis between baseline and 6th months of treatment	Use change of FibroScan measurement of liver between baseline and 6th months of treatment to express the change of liver fibrosis
Overall effectiveness of treatment defined by the guidelines for prevention and treatment of chronic hepatitis B	Overall effectiveness of treatment between baseline and 6th months of treatment	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.

Trial Locations

Locations (1)

Xi'an Traditional Medicine Hospital; 🇨🇳 Xi'an, Shaanxi, China