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

Primary Purpose

Hepatitis B， Chronic

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Standard - Yinchengao Decoction plus Ganlu Detoxification Pill
Entecavir or Tenofovir
Standard - Ge Xia Zhu Yu Decoction
Advanced - Supplemented Taohong Huazhuo Decoction
Standard - Chaihu Shugan San
Advanced - Soothe the liver and regulate qi Decoction
Standard - Xiaoyao powder
Advanced - Supplemented Ganbi Decoction
Standard - Yiguan Decoction
Advanced - Supplemented Zimu Dan
Standard - Fuzilizhong Decoction plus Jinkui Shenqi Bolus
Advanced - Guifu Erxian Decoction
Advanced - Supplemented Ganji Decoction
Sponsored by
Xi'an Traditional Medicine Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis B， Chronic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Xi'an Traditional Medicine HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard CMF

Advanced CMF

Pure Entecavir or Tenofovir

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Traditional Chinese Medicine symptom scale

Secondary Outcome Measures

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
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.

Full Information

First Posted
January 6, 2017
Last Updated
January 10, 2017
Sponsor
Xi'an Traditional Medicine Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03018821
Brief Title
The Study of Two Different Chinese Traditional Medicine Treatment on Chronic Hepatitis B
Official Title
Efficacy Comparison Between Two Kind of Chinese Herbal Formulas on Traditional Chinese Medicine Syndromes Among Chronic Hepatitis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xi'an Traditional Medicine Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B， Chronic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard CMF
Arm Type
Active Comparator
Arm Description
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
Arm Title
Advanced CMF
Arm Type
Experimental
Arm 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). 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
Arm Title
Pure Entecavir or Tenofovir
Arm Type
Experimental
Arm Description
Use an anti-virus western drug alone (such as Entecavir or Tenofovir).
Intervention Type
Drug
Intervention Name(s)
Standard - Yinchengao Decoction plus Ganlu Detoxification Pill
Intervention Description
Yinchengao Decoction plus Ganlu Detoxification Pill is one Chinese Medicine Formula for the TCM syndrome: Damp-heat blocking middle jiao.
Intervention Type
Drug
Intervention Name(s)
Entecavir or Tenofovir
Intervention Description
Western drug for anti-HBV such as Entecavir and Tenofovir
Intervention Type
Drug
Intervention Name(s)
Standard - Ge Xia Zhu Yu Decoction
Intervention Description
Ge Xia Zhu Yu Decoction is one Chinese Medicine Formula for the TCM syndrome: internal blood stasis.
Intervention Type
Drug
Intervention Name(s)
Advanced - Supplemented Taohong Huazhuo Decoction
Intervention Description
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
Intervention Name(s)
Standard - Chaihu Shugan San
Intervention Description
Chaihu Shugan San is one Chinese Medicine Formula for the TCM syndrome: Liver depression and qi stagnation.
Intervention Type
Drug
Intervention Name(s)
Advanced - Soothe the liver and regulate qi Decoction
Intervention Description
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
Intervention Name(s)
Standard - Xiaoyao powder
Intervention Description
Xiaoyao powder is one Chinese Medicine Formula for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
Intervention Type
Drug
Intervention Name(s)
Advanced - Supplemented Ganbi Decoction
Intervention Description
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
Intervention Name(s)
Standard - Yiguan Decoction
Intervention Description
Yiguan Decoction is one Chinese Medicine Formula for the TCM syndrome: Yin deficiency of liver and kidney.
Intervention Type
Drug
Intervention Name(s)
Advanced - Supplemented Zimu Dan
Intervention Description
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
Intervention Name(s)
Standard - Fuzilizhong Decoction plus Jinkui Shenqi Bolus
Intervention Description
Fuzilizhong Decoction plus Jinkui Shenqi Bolus is one Chinese Medicine Formula for the TCM syndrome: Yang deficiency of spleen and kidney.
Intervention Type
Drug
Intervention Name(s)
Advanced - Guifu Erxian Decoction
Intervention Description
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
Intervention Name(s)
Advanced - Supplemented Ganji Decoction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Traditional Chinese Medicine symptom scale
Time Frame
Change of TCM symptom scale between baseline and sixth months of treatment
Secondary Outcome Measure Information:
Title
The change of liver fibrosis
Description
Use change of FibroScan measurement of liver between baseline and 6th months of treatment to express the change of liver fibrosis
Time Frame
Chnage of liver fibrosis between baseline and 6th months of treatment
Title
Overall effectiveness of treatment defined by the guidelines for prevention and treatment of chronic hepatitis B
Description
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.
Time Frame
Overall effectiveness of treatment between baseline and 6th months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianmei Hao, MD
Phone
86-29-89626651
Email
12479088@qq.com
Facility Information:
Facility Name
Xi'an Traditional Medicine Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianmei Hao, MD
Phone
86-29-89626651
Email
12479088@qq.com

12. IPD Sharing Statement

Learn more about this trial

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

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