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Trial record 89 of 314 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Xi'an Traditional Medicine Hospital
Sponsor:
Information provided by (Responsible Party):
Xi'an Traditional Medicine Hospital
ClinicalTrials.gov Identifier:
NCT03018821
First received: January 6, 2017
Last updated: January 10, 2017
Last verified: January 2017
  Purpose
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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy Comparison Between Two Kind of Chinese Herbal Formulas on Traditional Chinese Medicine Syndromes Among Chronic Hepatitis Patients

Resource links provided by NLM:


Further study details as provided by Xi'an Traditional Medicine Hospital:

Primary Outcome Measures:
  • Traditional Chinese Medicine symptom scale [ Time Frame: Change of TCM symptom scale between baseline and sixth months of treatment ]

Secondary Outcome Measures:
  • The change of liver fibrosis [ Time Frame: 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 [ Time Frame: 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.



Estimated Enrollment: 250
Study Start Date: January 2017
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Drug: 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.
Drug: Entecavir or Tenofovir
Western drug for anti-HBV such as Entecavir and Tenofovir
Drug: Standard - Ge Xia Zhu Yu Decoction
Ge Xia Zhu Yu Decoction is one Chinese Medicine Formula for the TCM syndrome: internal blood stasis.
Drug: Standard - Chaihu Shugan San
Chaihu Shugan San is one Chinese Medicine Formula for the TCM syndrome: Liver depression and qi stagnation.
Drug: Standard - Xiaoyao powder
Xiaoyao powder is one Chinese Medicine Formula for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
Drug: Standard - Yiguan Decoction
Yiguan Decoction is one Chinese Medicine Formula for the TCM syndrome: Yin deficiency of liver and kidney.
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.
Experimental: 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
Drug: Entecavir or Tenofovir
Western drug for anti-HBV such as Entecavir and Tenofovir
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.
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.
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.
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.
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.
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.
Experimental: Pure Entecavir or Tenofovir
Use an anti-virus western drug alone (such as Entecavir or Tenofovir).
Drug: Entecavir or Tenofovir
Western drug for anti-HBV such as Entecavir and Tenofovir

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03018821

Contacts
Contact: Jianmei Hao, MD 86-29-89626651 12479088@qq.com

Locations
China, Shaanxi
Xi'an Traditional Medicine Hospital Recruiting
Xi'an, Shaanxi, China
Contact: Jianmei Hao, MD    86-29-89626651    12479088@qq.com   
Sponsors and Collaborators
Xi'an Traditional Medicine Hospital
  More Information

Responsible Party: Xi'an Traditional Medicine Hospital
ClinicalTrials.gov Identifier: NCT03018821     History of Changes
Other Study ID Numbers: XAZYYLS2017-02
Study First Received: January 6, 2017
Last Updated: January 10, 2017

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Liver Extracts
Tenofovir
Entecavir
Hematinics
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on September 21, 2017