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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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034810
Enrollment
Unknown
Registered
2020-07-20
Start date
2020-08-15
Completion date
Unknown
Last updated
2020-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hepatitis B

Interventions

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
eGFR;bone mineral density;

Secondary

MeasureTime frame
serum calcium, serum phosphorus;HBsAg, HBeAg, HBVDNA;Characteristics of TCM Syndromes;

Countries

China

Contacts

Public ContactXiaoling Chi

Guangdong Provincial Hospital of Chinese Medicine

chixiaolingqh@163.com+86 020-39318398

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026