PMID- 35341156
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220329
IS  - 1741-427X (Print)
IS  - 1741-4288 (Electronic)
IS  - 1741-427X (Linking)
VI  - 2022
DP  - 2022
TI  - Efficacy and Safety of Chuan Huang Fang Combining Reduced Glutathione in Treating 
      Acute Kidney Injury (Grades 1-2) on Chronic Kidney Disease (Stages 2-4): Study 
      Protocol for a Multicenter Randomized Controlled Clinical Trial.
PG  - 1099642
LID - 10.1155/2022/1099642 [doi]
LID - 1099642
AB  - BACKGROUND: Acute kidney injury (AKI) is a global public health challenge 
      resulting in considerable morbidity and mortality. AKI on chronic kidney disease 
      (CKD) (AKI on CKD, A on C) accounts for about a third of total AKI. For severe 
      AKI grade 3, renal replacement therapy (RRT) should be implemented in time. 
      However, the lack of recognized drug treatment method for AKI grades 1-2 is a 
      crucial problem in clinic. Chuan Huang Fang (CHF) is a Chinese herbal formulation 
      developed for the treatment of A on C from the Shanghai Municipal Hospital of 
      Traditional Chinese Medicine. Our previous studies suggested that CHF might 
      effectively protect renal functions of A on C patients. As a widely used 
      antioxidant in clinic, reduced glutathione (RG) is reported to improve the 
      clinical efficacy of high-flux hemodialysis (HFHD) in severe AKI patients 
      recently. To address the crucial problem mentioned above, thus we design a new 
      clinical protocol of CHF combining RG and try to evaluate the efficacy and safety 
      of this protocol in treating patients diagnosed with CKD stages 2-4 complicated 
      with AKI grades 1-2. METHODS: This is a multicenter randomized controlled 
      clinical trial. We intend to enroll 162 participants, and these participants will 
      be divided into the RG group, the CHF group, and the RG + CHF group randomly 
      assigning 1 : 1 : 1 principle. The RG group will be general treatments combining 
      RG, the CHF group will be general treatments combining CHF, and the RG + CHF 
      group will be general treatments combining RG and CHF. The duration of treatment 
      will last two weeks. The primary evaluation outcome will be the change in the 
      slope of serum creatinine (Scr) over 2 weeks. Secondary evaluation outcomes 
      include changes in blood urea nitrogen (BUN), estimated glomerular filtration 
      rate (eGFR), urinary AKI biomarkers (neutrophil gelatinase-associated lipocalin 
      (NGAL), interleukin-18 (IL-18), gamma-glutamyl transpeptidase (gamma-GT), etc.), 
      traditional Chinese medicine (TCM) symptoms, inflammatory indicators, and 
      oxidative stress indicators. Meanwhile, the vital sign indicators and adverse 
      events (AEs) will be closely observed. These dates will be meticulously recorded 
      and properly handled by investigators throughout the study. Discussion. This 
      study will provide convictive research-derived data to evaluate clinical efficacy 
      and safety of CHF combing RG for CKD stages 2-4 complicated with AKI grades 1-2 
      and provide an evidence-based recommendation for clinicians. The timely 
      completion of this trial will provide a novel drug treatment method for A on C. 
      This trial is registered with ChiCTR2100043311 and registered on February 9, 
      2021.
CI  - Copyright (c) 2022 Ling Chen and Xuezhong Gong.
FAU - Chen, Ling
AU  - Chen L
AUID- ORCID: 0000-0002-0293-5841
AD  - Department of Nephrology, Shanghai Municipal Hospital of Traditional Chinese 
      Medicine, Shanghai University of Traditional Chinese Medicine, 274 Zhijiang 
      Middle Road, Shanghai 200071, China.
FAU - Gong, Xuezhong
AU  - Gong X
AUID- ORCID: 0000-0002-4496-7972
AD  - Department of Nephrology, Shanghai Municipal Hospital of Traditional Chinese 
      Medicine, Shanghai University of Traditional Chinese Medicine, 274 Zhijiang 
      Middle Road, Shanghai 200071, China.
LA  - eng
PT  - Journal Article
DEP - 20220315
PL  - United States
TA  - Evid Based Complement Alternat Med
JT  - Evidence-based complementary and alternative medicine : eCAM
JID - 101215021
PMC - PMC8941542
COIS- The authors declare that they have no potential competing interests.
EDAT- 2022/03/29 06:00
MHDA- 2022/03/29 06:01
PMCR- 2022/03/15
CRDT- 2022/03/28 05:23
PHST- 2021/08/28 00:00 [received]
PHST- 2022/01/11 00:00 [revised]
PHST- 2022/02/22 00:00 [accepted]
PHST- 2022/03/28 05:23 [entrez]
PHST- 2022/03/29 06:00 [pubmed]
PHST- 2022/03/29 06:01 [medline]
PHST- 2022/03/15 00:00 [pmc-release]
AID - 10.1155/2022/1099642 [doi]
PST - epublish
SO  - Evid Based Complement Alternat Med. 2022 Mar 15;2022:1099642. doi: 
      10.1155/2022/1099642. eCollection 2022.