Phytomedicine : international journal of phytotherapy and phytopharmacology · 2025
Huangjia Ruangan granules with entecavir for fibrosis regression in Chroinc Hepatitis B: A multicenter, randomized, double-blind, phase II trial.
СтатьяКлиническое исследование II фазыРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Zhu Xiaojun, Zhang Jinghao, Zhou Zhijia, Liangpunsakul Suthat, Wang Jing, Ge Guohong, Tan Shanzhong, An Xuan, Sun Kewei, Wu Gang, Zhu Liying, Tang Jinmo, Song Xinwen, Zhang Anna, Lv Hui, Jiang Yongfang, Gou Chunyan, Li Man, Sun Xuehua, Gao Yueqiu
Аннотация
BACKGROUND: Huangjia Ruangan Granules (HRG) has shown promising therapeutic effects in treating hepatic fibrosis in China. This study aimed to assess its specific efficacy.
METHODS: This 48-week phase II study was a multicenter, randomized, double-blind, placebo-controlled trial conducted at 14 centers in China (No. ChiCTR2400086796). patients with chronic hepatitis B (CHB) and an Ishak fibrosis score between 2 to 5 were eligible for inclusion. Patients were randomly assigned to three groups (1:1:1 ratio): ETV (0.5 mg/day) + HRG-10g (10g/day, once daily), ETV (0.5 mg/day) + HRG-20g (10 g, twice daily), and ETV (0.5 mg/day) + placebo. The primary outcome was the change in fibrosis stage according to the Ishak scale. Safety assessments were conducted throughout the trial.
RESULTS: A total of 240 participants were randomly allocated to three treatment groups: ETV+HRG-10g (n=80), ETV+HRG-20g (n=79), or ETV+placebo (n=80). After 48 weeks, the ETV+HRG-20g group showed a significantly higher fibrosis regression rate (≥1 stage improvement in histopathology) was in the compared to both the ETV+HRG-10g group (67.09 % vs. 36.25 %; 95 % CI, 15.81-45.6) and the ETV+placebo group (67.09 % vs. 26.25 %; difference, 40.69 %; 95 % CI, 26.55-54.83).
CONCLUSIONS: Combining a 20g dose of the TCM formula HRG with ETV significantly enhances liver fibrosis regression in CHB patients.
METHODS: This 48-week phase II study was a multicenter, randomized, double-blind, placebo-controlled trial conducted at 14 centers in China (No. ChiCTR2400086796). patients with chronic hepatitis B (CHB) and an Ishak fibrosis score between 2 to 5 were eligible for inclusion. Patients were randomly assigned to three groups (1:1:1 ratio): ETV (0.5 mg/day) + HRG-10g (10g/day, once daily), ETV (0.5 mg/day) + HRG-20g (10 g, twice daily), and ETV (0.5 mg/day) + placebo. The primary outcome was the change in fibrosis stage according to the Ishak scale. Safety assessments were conducted throughout the trial.
RESULTS: A total of 240 participants were randomly allocated to three treatment groups: ETV+HRG-10g (n=80), ETV+HRG-20g (n=79), or ETV+placebo (n=80). After 48 weeks, the ETV+HRG-20g group showed a significantly higher fibrosis regression rate (≥1 stage improvement in histopathology) was in the compared to both the ETV+HRG-10g group (67.09 % vs. 36.25 %; 95 % CI, 15.81-45.6) and the ETV+placebo group (67.09 % vs. 26.25 %; difference, 40.69 %; 95 % CI, 26.55-54.83).
CONCLUSIONS: Combining a 20g dose of the TCM formula HRG with ETV significantly enhances liver fibrosis regression in CHB patients.