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

Xi'an Traditional Medicine Hospital

Status

Unknown

Conditions

Hepatitis B， Chronic

Treatments

Drug: Advanced - Supplemented Zimu Dan

Drug: Standard - Fuzilizhong Decoction plus Jinkui Shenqi Bolus

Drug: Advanced - Supplemented Taohong Huazhuo Decoction

Drug: Entecavir or Tenofovir

Drug: Advanced - Supplemented Ganbi Decoction

Drug: Standard - Chaihu Shugan San

Drug: Standard - Ge Xia Zhu Yu Decoction

Drug: Standard - Yiguan Decoction

Drug: Advanced - Soothe the liver and regulate qi Decoction

Drug: Standard - Yinchengao Decoction plus Ganlu Detoxification Pill

Drug: Advanced - Guifu Erxian Decoction

Drug: Advanced - Supplemented Ganji Decoction

Drug: Standard - Xiaoyao powder

Study type

Interventional

Funder types

Other

Identifiers

NCT03018821

XAZYYLS2017-02

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

250 participants in 3 patient groups

Standard CMF

Active Comparator group

Description:

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

Treatment:

Drug: Standard - Yiguan Decoction

Drug: Standard - Yinchengao Decoction plus Ganlu Detoxification Pill

Drug: Standard - Chaihu Shugan San

Drug: Standard - Fuzilizhong Decoction plus Jinkui Shenqi Bolus

Drug: Entecavir or Tenofovir

Drug: Standard - Xiaoyao powder

Drug: Standard - Ge Xia Zhu Yu Decoction

Advanced CMF

Experimental group

Description:

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

Treatment:

Drug: Advanced - Supplemented Ganbi Decoction

Drug: Advanced - Supplemented Zimu Dan

Drug: Advanced - Soothe the liver and regulate qi Decoction

Drug: Advanced - Supplemented Ganji Decoction

Drug: Advanced - Supplemented Taohong Huazhuo Decoction

Drug: Entecavir or Tenofovir

Drug: Advanced - Guifu Erxian Decoction

Pure Entecavir or Tenofovir

Experimental group

Description:

Use an anti-virus western drug alone (such as Entecavir or Tenofovir).