Effect of Jiuwei Zhuhuang Powder on Cough Resolution in Children with Upper Respiratory Tract Infections: A Multicenter Randomized Controlled Trial.
10.1007/s11655-021-3462-x
- Author:
Hui LUO
1
;
Gui-Hua SONG
2
;
Xiao-Jian MA
3
;
Meng-Meng SUN
2
;
Man ZHANG
4
;
Jian-Rong XIE
5
;
Shao PENG
6
Author Information
1. Institute for Tibetan Medicine, China Tibetology Research Center, Beijing, 100101, China.
2. Department of Pediatrics, the First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, 450000, China.
3. Department of Pediatrics, Huaihe Hospital of Henan University, Zhengzhou, 450000, China.
4. Department of Pediatrics, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, 475000, China.
5. School of Statistics, Renmin University of China, Beijing, 100872, China.
6. Department of Pediatrics, the First Affiliated Hospital of Zhengzhou University, Zhengzhou, 475000, China. Pengshaodh630@126.com.
- Publication Type:Randomized Controlled Trial
- Keywords:
Jiuwei Zhuhuang Powder;
Tibetan medicine;
child cough;
randomized controlled trial;
upper respiratory tract infection
- MeSH:
Child;
Cough/drug therapy*;
Drugs, Chinese Herbal;
Humans;
Nonprescription Drugs;
Powders;
Respiratory Tract Infections/drug therapy*
- From:
Chinese journal of integrative medicine
2022;28(5):387-393
- CountryChina
- Language:English
-
Abstract:
OBJECTIVE:To assess the effectiveness of Jiuwei Zhuhuang Powder (JWZH), a Tibetan patent medicine in treating upper respiratory tract infection (URTI) associated cough in children.
METHODS:The study was a multicenter, randomized, open-label, controlled trial. A total of 142 children aged 2 to 14 years old, with URTI-associated cough within 48 h of onset, were randomly assigned to two groups at a 1:1 ratio by computer-generated randomization sequence. Children were treated with JWZH (1 to 1.5 g, twice to thrice daily) in the treatment group or conventional treatment (Pediatric Paracetamol, Artificial Cow-bezoar and Chlorphenamine Maleate Granules, 0.25 to 1 g, thrice daily) in the control group for 5 days. The primary endpoints were the time to cough resolution and 4-day cough resolution rate. The secondary endpoints were the daily improvement in symptom scores and cough resolution rate during the study period.
RESULTS:A total of 138 children were included in the intention-to-treat analysis, with 71 cases in the treatment group and 67 cases in the control group. Compared with the conventional treatment, the children receiving JWZH had a shorter time to cough resolution [hazard ratio, 2.10; 95% confidence interval (CI), 1.29-3.40; P=0.003]. The median time to cough resolution for children receiving JWZH was shorter than that of the conventional treatment (2 days vs. 3 days; P<0.001). The 4-day cough resolution rate in the JWZH group was higher than that of the control group (94.4% vs. 74.6%; risk difference: 19.8%, 95% CI: 8.1%-31.5%; relative risk: 1.265, 95% CI: 1.088-1.470; P=0.001). There were no statistically significant differences in the improvement of other symptoms caused by URTI (P>0.05). Adverse events was reported in 5.6% (4/71) and 4.5% (3/67) in participants of JWZH and PPACCM groups (P>0.05), respectively, which were all mild and resolved without treatment.
CONCLUSION:JWZH seemed to be a safe and effective therapy for URTI-associated cough in children. (Trial registration No. ChiCTR2000039421).
