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

NCT ID: NCT03018821

Last Updated: 2017-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-12-31

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.

Detailed Description

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Conditions

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Hepatitis B, Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard CMF

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

Group Type ACTIVE_COMPARATOR

Standard - Yinchengao Decoction plus Ganlu Detoxification Pill

Intervention Type DRUG

Yinchengao Decoction plus Ganlu Detoxification Pill is one Chinese Medicine Formula for the TCM syndrome: Damp-heat blocking middle jiao.

Entecavir or Tenofovir

Intervention Type DRUG

Western drug for anti-HBV such as Entecavir and Tenofovir

Standard - Ge Xia Zhu Yu Decoction

Intervention Type DRUG

Ge Xia Zhu Yu Decoction is one Chinese Medicine Formula for the TCM syndrome: internal blood stasis.

Standard - Chaihu Shugan San

Intervention Type DRUG

Chaihu Shugan San is one Chinese Medicine Formula for the TCM syndrome: Liver depression and qi stagnation.

Standard - Xiaoyao powder

Intervention Type DRUG

Xiaoyao powder is one Chinese Medicine Formula for the TCM syndrome: Stagnation of liver qi and spleen deficiency.

Standard - Yiguan Decoction

Intervention Type DRUG

Yiguan Decoction is one Chinese Medicine Formula for the TCM syndrome: Yin deficiency of liver and kidney.

Standard - Fuzilizhong Decoction plus Jinkui Shenqi Bolus

Intervention Type DRUG

Fuzilizhong Decoction plus Jinkui Shenqi Bolus is one Chinese Medicine Formula for the TCM syndrome: Yang deficiency of spleen and kidney.

Advanced CMF

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

Group Type EXPERIMENTAL

Entecavir or Tenofovir

Intervention Type DRUG

Western drug for anti-HBV such as Entecavir and Tenofovir

Advanced - Supplemented Taohong Huazhuo Decoction

Intervention Type 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.

Advanced - Soothe the liver and regulate qi Decoction

Intervention Type 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.

Advanced - Supplemented Ganbi Decoction

Intervention Type 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.

Advanced - Supplemented Zimu Dan

Intervention Type 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.

Advanced - Guifu Erxian Decoction

Intervention Type 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.

Advanced - Supplemented Ganji Decoction

Intervention Type 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.

Pure Entecavir or Tenofovir

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

Group Type EXPERIMENTAL

Entecavir or Tenofovir

Intervention Type DRUG

Western drug for anti-HBV such as Entecavir and Tenofovir

Interventions

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Standard - Yinchengao Decoction plus Ganlu Detoxification Pill

Yinchengao Decoction plus Ganlu Detoxification Pill is one Chinese Medicine Formula for the TCM syndrome: Damp-heat blocking middle jiao.

Intervention Type DRUG

Entecavir or Tenofovir

Western drug for anti-HBV such as Entecavir and Tenofovir

Intervention Type DRUG

Standard - Ge Xia Zhu Yu Decoction

Ge Xia Zhu Yu Decoction is one Chinese Medicine Formula for the TCM syndrome: internal blood stasis.

Intervention Type DRUG

Advanced - Supplemented Taohong Huazhuo Decoction

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.

Intervention Type DRUG

Standard - Chaihu Shugan San

Chaihu Shugan San is one Chinese Medicine Formula for the TCM syndrome: Liver depression and qi stagnation.

Intervention Type DRUG

Advanced - Soothe the liver and regulate qi Decoction

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.

Intervention Type DRUG

Standard - Xiaoyao powder

Xiaoyao powder is one Chinese Medicine Formula for the TCM syndrome: Stagnation of liver qi and spleen deficiency.

Intervention Type DRUG

Advanced - Supplemented Ganbi Decoction

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.

Intervention Type DRUG

Standard - Yiguan Decoction

Yiguan Decoction is one Chinese Medicine Formula for the TCM syndrome: Yin deficiency of liver and kidney.

Intervention Type DRUG

Advanced - Supplemented Zimu Dan

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.

Intervention Type DRUG

Standard - Fuzilizhong Decoction plus Jinkui Shenqi Bolus

Fuzilizhong Decoction plus Jinkui Shenqi Bolus is one Chinese Medicine Formula for the TCM syndrome: Yang deficiency of spleen and kidney.

Intervention Type DRUG

Advanced - Guifu Erxian Decoction

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.

Intervention Type DRUG

Advanced - Supplemented Ganji Decoction

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.

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xi'an Traditional Medicine Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Xi'an Traditional Medicine Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jianmei Hao, MD

Role: CONTACT

86-29-89626651

Facility Contacts

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Jianmei Hao, MD

Role: primary

86-29-89626651

Other Identifiers

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XAZYYLS2017-02

Identifier Type: -

Identifier Source: org_study_id

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