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

Hepatitis B, Chronic Clinical Trial

Official title:

Efficacy Comparison Between Two Kind of Chinese Herbal Formulas on Traditional Chinese Medicine Syndromes Among Chronic Hepatitis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03018821
• Other study ID #: XAZYYLS2017-02
• Status: Recruiting
• Phase: N/A
• First received: January 6, 2017
• Last updated: January 10, 2017
• Start date: January 2017
• Est. completion date: December 2017

Study information

• Verified date: January 2017
• Source: Xi'an Traditional Medicine Hospital
• Contact: Jianmei Hao, MD
• Phone: 86-29-89626651
• Email: 12479088[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

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.
• Entecavir or Tenofovir
Western drug for anti-HBV such as Entecavir and Tenofovir
• Standard - Ge Xia Zhu Yu Decoction
Ge Xia Zhu Yu Decoction is one Chinese Medicine Formula for the TCM syndrome: internal blood stasis.
• 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.
• Standard - Chaihu Shugan San
Chaihu Shugan San is one Chinese Medicine Formula for the TCM syndrome: Liver depression and qi stagnation.
• 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.
• Standard - Xiaoyao powder
Xiaoyao powder is one Chinese Medicine Formula for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
• 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.
• Standard - Yiguan Decoction
Yiguan Decoction is one Chinese Medicine Formula for the TCM syndrome: Yin deficiency of liver and kidney.
• 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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
China	Xi'an Traditional Medicine Hospital	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xi'an Traditional Medicine Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Traditional Chinese Medicine symptom scale		Change of TCM symptom scale between baseline and sixth months of treatment	No
Secondary	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	Chnage of liver fibrosis between baseline and 6th months of treatment	No
Secondary	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.	Overall effectiveness of treatment between baseline and 6th months of treatment	No