Traditional Chinese medicine syndrome characteristics of chronic hepatitis B patients with renal function damage and bone mineral density reduction after antiviral treatment and improvement of bone mineral density in chronic hepatitis B patients treated with tenofovir alafenamide fumarate

Phase 4

• Conditions: chronic hepatitis B

• Registration Number: ITMCTR2000003502
• Lead Sponsor: Guangdong Provincial Hospital of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Part 1
(1) having a history of chronic hepatitis B.
(2) Nucleoside (acid) antiviral treatment >= 24 weeks.
(3) willing to cooperate with the study and sign the informed consent.
Part 2
(1) having a history of chronic hepatitis B.
(2) Age: 18-65 years old.
(3) Nucleoside (acid) antiviral treatment >= 24 weeks.
(4) combined with bone mineral density decreased.
(5) willing to cooperate with the research and sign the informed consent.

Exclusion Criteria

Part 1
(1) With a definite history of chronic kidney disease or osteoporosis before antiviral therapy.
(2) In addition to antiviral drugs, receiving kidney damage drugs or glucocorticoids that can lead to osteoporosis.
(3) Pregnant or lactating women.
Part 2
(1) With a definite history of chronic kidney disease or osteoporosis before antiviral therapy.
(2) In addition to antiviral drugs, receiving kidney damage drugs or glucocorticoids that can lead to osteoporosis.
(3) Co-infection with HAV, HCV, HDV, HEV or HIV.
(4) Combined with pituitary, parathyroid and other diseases that affect calcium and phosphorus metabolism,or receiving drugs affecting calcium and phosphorus metabolism.
(5) Combined with secondary liver disease caused by severe malnutrition, total parenteral nutrition, weight loss after bariatric surgery, drug, environmental or industrial toxicosis.
(6) Combined with cardiovascular, brain, kidney and other serious organic diseases and severe primary diseases of hematopoietic system.
(7) Patients with poor compliance and unable to adhere to treatment.
(8) combined with liver cancer or cancers of other organs.
(9) Pregnant or lactating women.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
bone mineral density;eGFR;

Secondary Outcome Measures

Name	Time	Method
serum calcium, serum phosphorus;Characteristics of TCM Syndromes;HBsAg, HBeAg, HBVDNA;