PMID- 36540716
OWN - NLM
STAT- MEDLINE
DCOM- 20221222
LR  - 20221222
IS  - 1177-8881 (Electronic)
IS  - 1177-8881 (Linking)
VI  - 16
DP  - 2022
TI  - Efficiency and Safety of Baofei Granules in Chronic Obstructive Pulmonary Disease 
      (Lung and Spleen Qi Deficiency Syndrome): A Multicenter, Randomized, 
      Double-Blind, Placebo-Controlled Phase II Clinical Trial.
PG  - 4251-4267
LID - 10.2147/DDDT.S382285 [doi]
AB  - BACKGROUND: Baofei Granules (BFGs) have been extensively applied in the clinical 
      treatment of chronic obstructive pulmonary disease (COPD) and significantly have 
      affected COPD patients with lung and spleen qi deficiency syndrome. However, the 
      data from previous small-sample clinical trials are limited. This trial aimed to 
      estimate the efficiency and safety of BFGs in COPD with lung and spleen qi 
      deficiency syndrome. METHODS: It is a multicenter, randomized, double-blind, 
      placebo-controlled phase II clinical trial. The 216 stable COPD patients will be 
      divided randomly in a ratio of 1:1. The whole trial period consists of a 4-week 
      introductory period, a 52-week treatment period and a 48-week follow-up. Study 
      visits occur every 4 weeks during the treatment period and every 12 weeks during 
      the follow-up. All the subjects will receive 10g BFGs or placebo three times per 
      day for 56 weeks and be followed up for 48 weeks. The primary efficiency 
      evaluation outcome will be the frequency and duration of AECOPD, and the 
      secondary efficiency evaluation outcome will be pulmonary function tests (PFTs), 
      modified Medical Research Council (mMRC) dyspnoea scale, six-minute walking test 
      (6MWT), COPD assessment test (CAT) score, traditional Chinese medicine (TCM) 
      syndrome score, the frequency of emergency medication, BODE index, and the time 
      to first Clinically important deterioration (CID). The safety evaluation outcomes 
      will be adverse events (AEs), vital signs, physical examination, twelve-lead 
      electrocardiogram (ECG), and laboratory examinations. All the data will be 
      analyzed by SAS9.4. DISCUSSION: This is the first and largest clinical trial that 
      evaluates the efficiency and safety of BFGs for COPD with lung and spleen qi 
      deficiency syndrome. It will provide valuable clinical evidence for 
      recommendations on COPD management by the integrated TCM and western medicine. 
      TRIAL REGISTRATION: CTR20211280. Date: June 09, 2021. 
      http://www.chinadrugtrials.org.cn/clinicaltrials.searchlistdetail.dhtml?id=383a370ecd9f43d7af6f1c8585779e1a.
CI  - (c) 2022 Sun et al.
FAU - Sun, Yuan
AU  - Sun Y
AUID- ORCID: 0000-0002-4900-7030
AD  - Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 
      201203, People's Republic of China.
FAU - Chen, Xuan
AU  - Chen X
AD  - Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 
      201203, People's Republic of China.
FAU - Zhang, Lei
AU  - Zhang L
AD  - Shanghai Innovation Center of TCM Health Service, Shanghai University of 
      Traditional Chinese Medicine, Shanghai, 201203, People's Republic of China.
FAU - Yuan, Wei-An
AU  - Yuan WA
AD  - Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 
      201203, People's Republic of China.
FAU - Chen, Qi
AU  - Chen Q
AD  - Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 
      201203, People's Republic of China.
FAU - Zhang, Yi-Bao
AU  - Zhang YB
AD  - Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 
      201203, People's Republic of China.
FAU - Liu, Lu-Jiong
AU  - Liu LJ
AD  - Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 
      201203, People's Republic of China.
FAU - Zhang, Wei
AU  - Zhang W
AD  - Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 
      201203, People's Republic of China.
FAU - Sun, Meng
AU  - Sun M
AD  - Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 
      201203, People's Republic of China.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20221214
PL  - New Zealand
TA  - Drug Des Devel Ther
JT  - Drug design, development and therapy
JID - 101475745
RN  - 0 (Drugs, Chinese Herbal)
SB  - IM
MH  - Humans
MH  - Qi
MH  - *Drugs, Chinese Herbal/adverse effects
MH  - Spleen
MH  - *Pulmonary Disease, Chronic Obstructive/diagnosis/drug therapy
MH  - Lung
MH  - Medicine, Chinese Traditional
MH  - Double-Blind Method
MH  - Treatment Outcome
PMC - PMC9759976
OTO - NOTNLM
OT  - Baofei Granules
OT  - chronic obstructive pulmonary disease
OT  - efficacy
OT  - safety
OT  - traditional Chinese medicine
COIS- The authors declare that they have no competing interests.
EDAT- 2022/12/22 06:00
MHDA- 2022/12/23 06:00
PMCR- 2022/12/14
CRDT- 2022/12/21 02:15
PHST- 2022/07/13 00:00 [received]
PHST- 2022/11/08 00:00 [accepted]
PHST- 2022/12/21 02:15 [entrez]
PHST- 2022/12/22 06:00 [pubmed]
PHST- 2022/12/23 06:00 [medline]
PHST- 2022/12/14 00:00 [pmc-release]
AID - 382285 [pii]
AID - 10.2147/DDDT.S382285 [doi]
PST - epublish
SO  - Drug Des Devel Ther. 2022 Dec 14;16:4251-4267. doi: 10.2147/DDDT.S382285. 
      eCollection 2022.