Patient recruitment
Dear friend:
Hello!
The randomized, double-blind, loaded, placebo-controlled, multicenter clinical study on the efficacy and safety of Zhuling polysaccharide capsules combined with Entecavir in the treatment of chronic hepatitis B with low-level viremia, sponsored by Hubei Mengyang Pharmaceutical Co., Ltd., is currently being conducted at Beijing You'an Hospital affiliated with Capital Medical University, Beijing Ditan Hospital affiliated with Capital Medical University, Zhejiang Hospital, and Shijiazhuang Fifth Hospital. The approval number of the drug is: National Pharmaceutical Approval Letter Z20184032. We are now publicly recruiting clinical research subjects to the society.
For those who meet the inclusion criteria, we will provide 48 weeks of treatment with Zhuling polysaccharide capsules/Zhuling polysaccharide capsule mimetics and corresponding free examinations. The examination includes blood routine examination, urine routine examination, liver function, kidney function, HBV-DNA, five items of hepatitis B (quantitative), pregnancy examination (women of childbearing age), 12 lead ECG, abdominal B ultrasound, alpha fetoprotein (AFP), etc.
Through this clinical study, you may obtain relief of symptoms, virological and serological markers related to low level viremia of chronic hepatitis B B for this disease. You will receive a subject transportation allowance after all clinical trial visits are completed.
According to the revised "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 Edition)" developed by the Infectious Disease Branch of the Chinese Medical Association and the Hepatology Branch of the Chinese Medical Association, the diagnostic criteria for hypoviremia in chronic hepatitis B.
1） HBsAg positivity lasts for more than 6 months;
2）Serum hepatitis B B e antigen (HBeAg) or hepatitis B B e antibody (anti HBe) is positive, or HBV-DNA is detected;
3）HBV-DNA< 2000 IU/mL.
You will also receive
Experienced experts closely observe and treat your condition
Inclusion Criteria
If you meet:
(1) Compliant with the revised Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 Edition) issued by the Infectious Disease Branch of the Chinese Medical Association and the Hepatology Branch of the Chinese Medical Association, clinically diagnosed as a patient with chronic hepatitis B;
(2) Traditional Chinese medicine syndrome differentiation is liver and gallbladder damp heat syndrome;
(3) Age range from 18 to 70 years old (including upper and lower limits), regardless of gender;
(4) Subjects of childbearing age are willing to voluntarily take adequate contraceptive measures from the date of signing the informed consent form until 3 months after the last dose, and agree to use non pharmacological complete contraception during the study period;
(5) Individuals who have been using entecavir for antiviral treatment for at least 6 consecutive months or more in the past;
(6) Agree not to change the current antiviral treatment plan during this research process;
(7) 10 IU/mL< HBV DNA< 2000 IU/mL;
(8) Outpatient patients;
(9) Sign informed consent and voluntarily participate in this clinical study.
contact information
If you meet the above conditions and voluntarily participate, please contact us, or go to the Integrated Traditional Chinese and Western Medicine Center of Beijing You'an Hospital affiliated to Capital Medical University, the Integrated Traditional Chinese and Western Medicine Center of Beijing Ditan Hospital affiliated to Capital Medical University, the Department of infectious diseases of Zhejiang Hospital, and the outpatient/ward doctor office of the First Department of Infection (Department of Traditional Chinese Medicine Hepatology) of Shijiazhuang Fifth Hospital to understand the details of the study. A special person will be assigned to introduce the purpose, content, procedures, risks, benefits, and other specific contents of the study, as well as the situation that is not suitable for participating in the study.
General contact person:
Teacher Xia 18518085251/Teacher Yang 15824898317
Contact person for each hospital:
Teacher (Beijing You'an Hospital Affiliated to Capital Medical University)15835768893
Teacher Zhang (Beijing Ditan Hospital Affiliated to Capital Medical University)13019233196
Teacher Luo (Zhejiang Hospital)15967189490
Teacher Wang (Shijiazhuang Fifth Hospital)15226877527
