The Study of Two Different Chinese Traditional Medicine Treatment on Chronic Hepatitis B
Efficacy Comparison Between Two Kind of Chinese Herbal Formulas on Traditional Chinese Medicine Syndromes Among Chronic Hepatitis Patients
1 other identifier
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P75+ for not_applicable
Started Jan 2017
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 6, 2017
CompletedFirst Posted
Study publicly available on registry
January 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJanuary 12, 2017
January 1, 2017
9 months
January 6, 2017
January 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Traditional Chinese Medicine symptom scale
Change of TCM symptom scale between baseline and sixth months of treatment
Secondary Outcomes (2)
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
Overall effectiveness of treatment between baseline and 6th months of treatment
Study Arms (3)
Standard CMF
ACTIVE COMPARATORStandard 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
EXPERIMENTALAdvanced 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
EXPERIMENTALUse an anti-virus western drug alone (such as Entecavir or Tenofovir).
Interventions
Yinchengao Decoction plus Ganlu Detoxification Pill is one Chinese Medicine Formula for the TCM syndrome: Damp-heat blocking middle jiao.
Western drug for anti-HBV such as Entecavir and Tenofovir
Ge Xia Zhu Yu Decoction is one Chinese Medicine Formula for the TCM syndrome: internal blood stasis.
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.
Chaihu Shugan San is one Chinese Medicine Formula for the TCM syndrome: Liver depression and qi stagnation.
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.
Xiaoyao powder is one Chinese Medicine Formula for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
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.
Yiguan Decoction is one Chinese Medicine Formula for the TCM syndrome: Yin deficiency of liver and kidney.
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.
Fuzilizhong Decoction plus Jinkui Shenqi Bolus is one Chinese Medicine Formula for the TCM syndrome: Yang deficiency of spleen and kidney.
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.
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.
Eligibility Criteria
You may qualify if:
- \<=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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Xi'an Traditional Medicine Hospital
Xi'an, Shaanxi, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2017
First Posted
January 12, 2017
Study Start
January 1, 2017
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
January 12, 2017
Record last verified: 2017-01