Efficacy and Safety of Regan Tangjiang for Treating the Common Cold With Wind-heat Syndrome: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled Phase 2b Study

Efficacy and Safety of Regan Tangjiang for treating the common cold with wind-heat syndrome: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled Phase 2b Study

开始日期2017-03-01

申办/合作机构

Beijing Da-an Bio-technology Co., Ltd.

CTR20132670 / Recruiting临床2期

热感糖浆与安慰剂对照治疗感冒（风热证）随机、双盲、多中心临床试验

初步评价热感糖浆治疗风热感冒的有效性、安全性

开始日期2013-08-24

申办/合作机构

江西本草天工科技有限责任公司

[+1]

100 项与热感糖浆相关的临床结果

登录后查看更多信息

100 项与热感糖浆相关的转化医学

登录后查看更多信息

100 项与热感糖浆相关的专利（医药）

登录后查看更多信息

项与热感糖浆相关的文献（医药）

2023-04-01·Zhongguo Zhong yao za zhi = Zhongguo zhongyao zazhi = China journal of Chinese materia medica

[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].

Article

作者: Dong, Hui ; Hu, Yi-Min ; Chen, Ye-Yang ; Liu, Qing-Quan ; Chen, Sheng ; Chen, Ning ; Wang, Lan ; Long, You-Yu ; Liu, Nan

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.

2000-02-01·Diagnostic Microbiology and Infectious Disease4区 · 医学

Assessment of the FAN anaerobic bottle for culture of continuous ambulatory peritoneal dialysis fluid using the BacT/Alert system

4区 · 医学

Article

作者: G.K.M. Harding ; P. Van Caeseele ; M.J. Alfaa

The purpose of this study was to determine if the newly available FAN anaerobic bottle (FANAN) alone would be comparable to the combination of the FAN aerobic (FANAE) plus the standard BacT/Alert anaerobic (REGAN) bottles for culture of continuous ambulatory peritoneal dialysis (CAPD) fluid from patients with CAPD peritonitis. CAPD fluid (10 mL) was injected into each bottle, which was then monitored by the BacT/Alert instrument by using a 7-day protocol. Aerobic and anaerobic terminal subculture were performed on all bottles before they were classified as being culture negative. There were 181 effluents received that were suitable for analysis. Growth was detected in 76 (42%) effluents by at least one method. FANAE was the single best medium detecting 84/96 (88%) of all organisms whereas the FANAN and REGAN each detected 69/96 (72%). The combination of FANAE and REGAN bottles detected 92/96 (96%) isolates, which was significantly better than the FANAN or FANAE alone for isolate recovery (p < 0.001). The isolates that were missed by the FANAN but that were recovered by either FANAE or REGAN were all facultative anaerobes commonly detected in CAPD fluids. Terminal subculture revealed otherwise undetected pathogens in 3.9% of positive effluents, usually Pseudomonas aeruginosa. Based on our data, FANAE was the single best bottle for detection of CAPD peritonitis and, in combination with an anaerobic bottle, detected growth from the most effluents. FANAN alone could not substitute for the FANAE/REGAN combination. Although terminal subculture remains controversial, we recommend routine aerobic subculture to ensure that no P. aeruginosa isolates are missed.

1995-09-01·Journal of Cataract and Refractive Surgery2区 · 医学

Effect of age and astigmatism on the AMO Array multifocal intraocular lens

2区 · 医学

Article

作者: Jacobi, P C ; Konen, W

Multifocal intraocular lenses (MIOLs) have been designed to provide better uncorrected near visual acuity than monofocal IOLs. However, the increase in depth of focus is combined with a significant decrease in contrast sensitivity and glare. We implanted a new zonal-progressive MIOL (AMO Array) in 31 eyes of 25 patients whose mean age was 60.8 +/- 13.5 years. At 12.1 +/- 2.4 months postoperatively, the uncorrected visual acuity averaged 0.56 +/- 0.09 (20/32) for distance and 0.54 +/- 0.12 (20/40) for near focus. Seventy-five percent of patients achieved a best corrected distance visual acuity of > or = 0.9 (20/22). With distance correction only, mean near visual acuity was 0.72 +/- 0.17 (20/25). Best corrected near acuity reached 0.89 +/- 0.11 (20/22), requiring an additional near add of +1.0 to +2.0 diopters (D). We observed an age-dependent difference in the depth of focus. In younger patients (46 +/- 6 years), the pseudoaccommodation range was 6.25 D; acuity attained was > or = 0.4 (20/50). In older patients (71 +/- 7 years), visual acuity at the near focus was substantially reduced (two lines). Regan contrast sensitivity was lower for MIOL patients at all contrast levels, but the difference was statistically significant only at very low contrast (11%). Contrast sensitivity and glare were dependent on the patient's age but did not change with the amount of postoperative astigmatism. Younger patients were very satisfied with the results of MIOL implantation, and the small loss of contrast sensitivity was counterbalanced by the advantage of improved depth of focus and uncorrected near visual acuity.

100 项与热感糖浆相关的药物交易

登录后查看更多信息

研发状态

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
普通感冒	临床2期	中国	大百汇生物科技（深圳）有限公司	2013-08-24
普通感冒	临床2期	中国	江西本草天工科技有限责任公司	2013-08-24