Delving into the Latest Updates on Fuzheng Jiedu Granules with Synapse

Overview

Basic Info

Drug Type

Herbal medicine

Synonyms-

Target-

Action-

Mechanism-

Therapeutic Areas

Infectious DiseasesRespiratory Diseases

Active Indication-

Inactive Indication

Acute upper respiratory infection

Originator Organization

Shanghai Yusen New Drug Development Co., Ltd.

Active Organization-

Inactive Organization

Shanghai Yusen New Drug Development Co., Ltd.

License Organization-

Drug Highest PhasePendingPhase 2

First Approval Date-

Regulation-

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Fuzheng Jiedu granules (FZJD) is widely used for COVID-19 in China, with early studies indicating reduced mortality in severe cases. However, with emerging variants and shifted treatment focus on preventing severity and relieving symptoms, high-level clinical evidence, especially for high-risk patients, remains lacking.

METHODS:

A randomized controlled trial (ChiCTR2200058181 ) was performed to assess FZJD's efficacy and safety in high-risk adults with non-severe COVID-19. The primary outcome was the proportion of progression to severe COVID-19 after enrollment, with secondary outcomes focusing on the time to resolution of main symptoms.

RESULTS:

From November 2021 to July 2022, 231 eligible patients were randomized to receive either 15 g of FZJD (n = 119) or placebo (n = 112) thrice daily for 14 days. Patients receiving FZJD (1/101, 1.0 % [95 % CI, 0.0 %, 5.4 %]) had a numerically lower progression proportion to severe COVID-19 than those receiving placebo (2/95, 2.1 % [95 % CI, 0.3 %, 7.4 %]), although with a non-significant difference of -1.1 % (95 % CI, -7.4 %, 6.2 %; p = 0.545) after adjusted by center. FZJD use was associated with significantly shorter time to sustained disappearance of cough (median days, 10.0 vs. 12.0, HR, 1.46 [1.03, 2.07], p = 0.022), fever (median days, 6.0 vs. 7.0, HR, 1.69 [1.03, 2.76], p = 0.031), and chest distress (median days, 7.0 vs. 11.0, HR, 3.28 [1.23, 8.73], p = 0.031). Patients experience comparable adverse events in the two groups (2.7 % in FZJD vs. 1.9 % in placebo).

CONCLUSION:

Among high-risk COVID-19 patients, FZJD showed obvious symptom improvements and numerically lower disease progression than placebo, without additional adverse events.

01 May 2007·Zhongguo Zhong xi yi jie he za zhi Zhongguo Zhongxiyi jiehe zazhi = Chinese journal of integrated traditional and Western medicine

[Clinical observation on effects of Fuzheng Jiedu Granule in treating coronary heart disease patients in long term contact with nickel].

Article

Author: Wei, Zi-Tai ; Zhao, Jian-Xiong

OBJECTIVE:

To study the clinical efficacy of Fuzheng Jiedu Granule (FJG) in coronary heart disease (CHD) patients in long term contact with nickel (Ni) and its effect on electrocardiogram (ECG) and cardial enzymes.

METHODS:

Sixty cases were randomly assigned to two groups with 30 cases in each group, the treatment group treated with FJG plus Western medicine and the control group given Western medicine alone. The therapeutic course in both groups was 4 weeks. Another 15 healthy subjects from the same region were taken as the healthy control. Changes of clinical symptoms and ECG were observed, and the serum levels of creatine kinase (CK), lactic acid (LD), lactic dehydrogenase (LDH), Na+-K+-ATPase, Ca2+-ATPase and Ni were detected before and after treatment.

RESULTS:

The ameliorative effects on symptoms, signs and ECG in the treatment group were superior to those in the control group (P<0.05). Compared with healthy subjects, the serum levels of CK, LD, LDH and Ni were higher and the serum levels of Na+-K+-ATPase and Ca2+-ATPase were lower in patients before treatment; after treatment, the decrease of serum CK, LD, LDH and Ni levels and increase of serum Na+-K+-ATPase and Ca2+-ATPase were more significant in the treatment group than those in the control group (P<0.05 or P<0.01).

CONCLUSION:

FJG can decrease the serum Ni level, recover the activity of myocardial enzymes, thus to improve symptoms and abnormal ECG figures in CHD patients.

01 Aug 2001·Liver

Chinese medicinal herbs for chronic hepatitis B: a systematic review

Review

Author: Heather McIntosh ; Hui Lin ; Jianping Liu

Abstract:Aims/Background: Chronic hepatitis B is a serious health problem worldwide. Chinese medicinal herbs are widely used for treatment of chronic hepatitis B in China and many clinical trials have been conducted. This systematic review is to assess the efficacy and safety of Chinese medicinal herbs for chronic hepatitis B. Methods: Randomised clinical trials comparing Chinese medicinal herbs versus placebo, no intervention, nonspecific treatment, or interferon treatment for chronic hepatitis B with ≥3 months follow‐up were included. No language and blinding limitations were applied. The electronic databases were searched, combined with handsearches on Chinese literature. Data were extracted independently by two reviewers. The methodological quality of trials was assessed by the Jadad‐scale plus allocation concealment. Results: Nine randomised trials (n=936) were included, with only one being of high quality. There was a funnel plot asymmetry (intercept 3.37, p=0.047). Compared to nonspecific treatment or placebo, the herbal compound Fuzheng Jiedu Tang showed an effect on clearance of serum HBsAg (relative risk 5.19, 95% CI 1.24–21.79), HBeAg (10.85, 3.56–33.06), and HBV DNA (8.50, 1.23–58.85). Polyporus umbellatus polysaccharide showed an effect on serum HBeAg (3.06, 1.13–8.29) and HBV DNA (4.14, 1.0–17.19); Phyllanthus amarus showed an effect on serum HBeAg (3.35, 1.49–7.56). Phyllanthus compound and kurorinone showed no significant difference on clearance of serum HBeAg and HBV DNA and on alanine aminotransferase normalisation compared to interferon. No serious adverse event was observed. Conclusions: Chinese medicinal herbs are not recommended for chronic hepatitis B because of the publication bias and low quality of the trials. Rigorously designed, randomised, double‐blind, placebo‐controlled trials are needed.

100 Deals associated with Fuzheng Jiedu Granules

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