Efficacy and safety of Regan Syrup in treatment of common cold (wind-heat syndrome):a multicenter, randomized, double-blind, double-dummy, placebo and positive drug-controlled, parallel, phase Ⅱb clinical trial.
10.19540/j.cnki.cjcmm.20221201.501
- Author:
Yi-Min HU
1
;
Qing-Quan LIU
2
;
Sheng CHEN
3
;
Ye-Yang CHEN
4
;
Lan WANG
5
;
Nan LIU
6
;
Ning CHEN
7
;
You-Yu LONG
8
;
Hui DONG
9
Author Information
1. the Fourth Clinical Medical College of Guangzhou University of Chinese Medicine Shenzhen 518033, China Shenzhen Traditional Chinese Medicine Hospital Shenzhen 518033, China.
2. Beijing Hospital of Traditional Chinese Medicine, Capital Medical University Beijing 100010, China.
3. Shenzhen Traditional Chinese Medicine Hospital Shenzhen 518033, China.
4. Clinical College of Chinese Medicine, Gansu University of Chinese Medicine Lanzhou 730000, China.
5. Dongzhimen Hospital, Beijing University of Chinese Medicine Beijing 100700, China.
6. the First Affiliated Hospital of Guangzhou University of Chinese Medicine Guangzhou 510405, China.
7. Guangdong Second Traditional Chinese Medicine Hospital Guangzhou 510095, China.
8. Second Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin 300150, China.
9. Taian Traditional Chinese Medicine Hospital Taian 271000, China.
- Publication Type:Randomized Controlled Trial
- Keywords:
Regan Syrup;
clinical trial;
common cold(wind-heat syndrome);
efficacy;
safety
- MeSH:
Humans;
Antipyretics/therapeutic use*;
Capsules;
Common Cold/diagnosis*;
Double-Blind Method;
Fever/drug therapy*;
Hot Temperature;
Pharyngitis;
Treatment Outcome
- From:
China Journal of Chinese Materia Medica
2023;48(8):2233-2240
- CountryChina
- Language:Chinese
-
Abstract:
Regan Syrup has the effect of clearing heat, releasing exterior, benefiting pharynx and relieving cough, and previous phase Ⅱ clinical trial showed that the efficacy of Regan Syrup high-dose and low-dose groups was better than that of the placebo group, and there was no statistically significant difference in the safety between the three groups. The present study was conducted to further investigate the efficacy and safety of the recommended dose(20 mL) of Regan Syrup in the treatment of common cold(wind-heat syndrome). Patients who met the inclusion and exclusion criteria were selected and divided into the test group(Regan Syrup+Shufeng Jiedu Capsules placebo), positive drug group(Regan Syrup placebo+Shufeng Jiedu Capsules) and placebo group(Regan Syrup placebo+Shufeng Jiedu Capsules placebo) at a 1∶1∶1 using a block randomization method. The course of treatment was 3 days. A total of 119 subjects were included from six study centers, 39 in the test group, 40 in the positive drug group and 40 in the placebo group. The onset time of antipyretic effect was shorter in the test group than in the placebo group(P≤0.01) and the positive drug group, but the difference between the test group and the positive drug group was not significant. The test group was superior to the positive drug group in terms of fever resolution(P<0.05), and had a shorter onset time of fever resolution than the placebo group, but without obvious difference between the two groups. Compared to the positive drug group, the test group had shortened disappearance time of all symptoms(P≤0.000 1). In addition, the test group was better than the positive drug group and the placebo group in relieving symptoms of sore throat and fever(P<0.05), and in terms of clinical efficacy, the recovery rate of common cold(wind-heat syndrome) was improved in the test group compared to that in the placebo group(P<0.05). On the fourth day after treatment, the total TCM syndrome score in both test group and positive drug group was lower than that in the placebo group(P<0.05). There was no significant difference in the incidence of adverse events between three groups and none of them experienced any serious adverse events related to the study drug. The results indicated that Regan Syrup could shorten the onset time of antipyretic effect, reduce the time of fever resolution, alleviate the symptoms such as sore throat and fever caused by wind-heat cold, reduce the total score of Chinese medicine symptoms, and improve the clinical recovery rate with good safety.
