PMID- 35979216
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220819
IS  - 2296-858X (Print)
IS  - 2296-858X (Electronic)
IS  - 2296-858X (Linking)
VI  - 9
DP  - 2022
TI  - Jinhua Qinggan granules for non-hospitalized COVID-19 patients: A double-blind, 
      placebo-controlled, and randomized controlled trial.
PG  - 928468
LID - 10.3389/fmed.2022.928468 [doi]
LID - 928468
AB  - BACKGROUND: Key findings from the World Health Organization Expert Meeting on 
      Evaluation of Traditional Chinese Medicine (TCM) in treating coronavirus disease 
      2019 (COVID-19) reported that TCMs are beneficial, particularly for 
      mild-to-moderate cases. The efficacy of Jinhua Qinggan granules (JHQG) in 
      COVID-19 patients with mild symptoms has yet to be clearly defined. METHODS: We 
      conducted a phase 2/3, double-blind, randomized, placebo-controlled trial to 
      evaluate the efficacy and safety of treatment with JHQG in mild, 
      non-hospitalized, laboratory-confirmed COVID-19 patients. Participants were 
      randomly assigned to receive 5 g/sacket of JHQG or placebo granules orally thrice 
      daily for 10 days. The primary outcomes were the improvement in clinical symptoms 
      and a proportion tested negative on viral polymerase chain reaction (PCR) after 
      treatment. Secondary outcomes were the time to recover from clinical symptoms and 
      changes in white blood cells (WBC) and acute phase reactants (C-reactive protein 
      (CRP) and ferritin) on the 10th day after treatment initiation. RESULTS: A total 
      of 300 patients were randomly assigned to receive JHQG (150 patients) and placebo 
      (150 patients). Baseline characteristics were similar in the two groups. In the 
      modified intention-to-treat analysis, JHQG showed greater clinical efficacy 
      (82.67%) on the 10th day of the trial compared with the placebo group (10.74%; 
      rate difference: 71.93%; 95% CI 64.09-79.76). The proportion of patients with a 
      negative PCR after treatment was comparable (rate difference: -4.67%; 95% CI 
      -15.76 to 6.42). In contrast, all changes in WBC, ferritin, and CRP levels showed 
      a statistically significant decline in JHQG (P </= 0.044) after treatment, but not 
      the latter in placebo (P = 0.077). The median time to recovery of 
      COVID-19-related symptoms including cough, sputum, sore throat, dyspnea, 
      headache, nasal obstruction, fatigue, and myalgia was shorter in the JHQG group 
      compared to the placebo group (P < 0.001 for all). Three patients experienced 
      mild-to-moderate adverse events (AEs) duringthe treatment period in the JHQG 
      group. Findings were similar between the modified intention-to-treat and the 
      per-protocol analysis that included only patients who reported 100% adherence to 
      the assigned regimen. CONCLUSION: Based on the time to recover from the 
      COVID-19-related symptoms and AEs, it is concluded that JHQG is a safe and 
      effective TCM for symptomatic relief of patients with mild COVID-19. A 
      symptomatic improvement in the JHQG group patients was observed and JHQG use 
      would have important public health implications in such patients. CLINICAL TRIAL 
      REGISTRATION: The Trial was prospectively registered on www.clinicaltrials.gov 
      with registration number: NCT04723524.
CI  - Copyright (c) 2022 Shah, Fatima, Khan, Ullah, Himani, Wan, Lin, Lau, Liu and Lam.
FAU - Shah, Muhammad Raza
AU  - Shah MR
AD  - Center for Bioequivalence Studies and Clinical Research, Dr. Panjwani Center for 
      Molecular Medicine and Drug Research, International Center for Chemical and 
      Biological Sciences, University of Karachi, Karachi, Pakistan.
FAU - Fatima, Samreen
AU  - Fatima S
AD  - Center for Bioequivalence Studies and Clinical Research, Dr. Panjwani Center for 
      Molecular Medicine and Drug Research, International Center for Chemical and 
      Biological Sciences, University of Karachi, Karachi, Pakistan.
FAU - Khan, Sehrosh Naz
AU  - Khan SN
AD  - Center for Bioequivalence Studies and Clinical Research, Dr. Panjwani Center for 
      Molecular Medicine and Drug Research, International Center for Chemical and 
      Biological Sciences, University of Karachi, Karachi, Pakistan.
FAU - Ullah, Shafi
AU  - Ullah S
AD  - Center for Bioequivalence Studies and Clinical Research, Dr. Panjwani Center for 
      Molecular Medicine and Drug Research, International Center for Chemical and 
      Biological Sciences, University of Karachi, Karachi, Pakistan.
FAU - Himani, Gulshan
AU  - Himani G
AD  - The Indus Hospital Karachi, Karachi, Pakistan.
FAU - Wan, Kelvin
AU  - Wan K
AD  - School of Chinese Medicine of Hong Kong, Baptist University, Kowloon, Hong Kong 
      SAR, China.
FAU - Lin, Timothy
AU  - Lin T
AD  - School of Chinese Medicine of Hong Kong, Baptist University, Kowloon, Hong Kong 
      SAR, China.
FAU - Lau, Johnson Y N
AU  - Lau JYN
AD  - School of Chinese Medicine of Hong Kong, Baptist University, Kowloon, Hong Kong 
      SAR, China.
FAU - Liu, Qingquan
AU  - Liu Q
AD  - Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, 
      Beijing, China.
FAU - Lam, Dennis S C
AU  - Lam DSC
AD  - School of Chinese Medicine of Hong Kong, Baptist University, Kowloon, Hong Kong 
      SAR, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT04723524
PT  - Case Reports
DEP - 20220801
PL  - Switzerland
TA  - Front Med (Lausanne)
JT  - Frontiers in medicine
JID - 101648047
PMC - PMC9376460
OTO - NOTNLM
OT  - COVID-19
OT  - Chinese mineral medicine
OT  - Jinhua Qinggan granules (JHQG)
OT  - Traditional Chinese Medicine
OT  - randomized controlled (clinical) trial
COIS- The authors declare that the research was conducted in the absence of any 
      commercial or financial relationships that could be construed as a potential 
      conflict of interest.
EDAT- 2022/08/19 06:00
MHDA- 2022/08/19 06:01
PMCR- 2022/08/01
CRDT- 2022/08/18 02:14
PHST- 2022/04/25 00:00 [received]
PHST- 2022/07/04 00:00 [accepted]
PHST- 2022/08/18 02:14 [entrez]
PHST- 2022/08/19 06:00 [pubmed]
PHST- 2022/08/19 06:01 [medline]
PHST- 2022/08/01 00:00 [pmc-release]
AID - 10.3389/fmed.2022.928468 [doi]
PST - epublish
SO  - Front Med (Lausanne). 2022 Aug 1;9:928468. doi: 10.3389/fmed.2022.928468. 
      eCollection 2022.