Clinical Effectiveness and Safety of Bairui Granules （百蕊颗粒） in Treating Patients with Acute Pharyngitis with Wind-Heat Syndrome： A Multi-Center， Double-Blind， Double-Simulation， Randomized Controlled Trial / 中医杂志

ObjectiveTo evaluate the clinical effectiveness and safety of Bairui Granules （百蕊颗粒） in the treatment of acute pharyngitis with wind-heat syndrome. MethodsA multicenter， double-blind， double-simulation， randomised controlled trial was conducted， in which 162 patients with acute pharyngitis and wind-heat syndrome from 7 centers were recruited， and each center was divided into trial group and control group on the ratio of 2∶1. In the trial group， 108 cases were orally administered with Bairui Granules plus Reyanning Granules （热炎宁颗粒） simulant， and in the control group， 54 cases were orally administered with Reyanning Granules plus Bairui Granules simulant for 5 days， with a follow-up visit on the 6th day. Full analysis set （FAS） analysis and per protocol set （PPS） were used for analysis， respectively. The primary efficacy index was the disappearance rate of sore throat after 5-day treatment； the secondary efficacy indexes were the disappearance rate of sore throat after 3-day treatment， as well as the visual analogue score （VAS） of sore throat before treatment， every day during the treatment， and follow-up on day 6， and the traditional Chinese medicine （TCM） syndrome score was performed before treatment and at the follow-up on day 6. The effectiveness on TCM syndrome was evaluated at the follow-up on day 6， and the changes of vital signs， blood routine， urine routine， liver functions， kidney function， the adverse events before and after the treatment were recorded， and safety analysis set （SS） was analysed. Results162 patients entered the FAS and SS analyses， and 158 cases （105 cases in the trial group and 53 cases in the control group） entered the PPS analysis. FAS analysis showed that the disappearance rate of sore throat after 5-day treatment was 80.56% （87/108） in the trial group and 64.81% （35/54） in the control group， and the difference between groups was statistically significant （χ2 = 5.10， P = 0.0239）. PPS analysis showed that the disappearance rate of sore throat after 5-day treatment was 80.00% （84/105） in the trial group and 64.15% （34/53） in the control group， and the difference between groups was statistically significant （χ2 =4.85， P = 0.0277）. FAS and SS analyses both showed that the difference in disappearance rate of sore throat between groups on 3-day treatment was not statistically significant （P＞0.05）. Compared with those before treatment， the VAS scores of sore throat were lower in both groups during treatment on day 2， 3， 4， 5， and follow-up on day 6 （P＜0.01）， but the difference between groups at each time point was not statistically significant （P＞0.05）. TCM syndrome scores of both groups at the follow-up were lower than that before treatment， and those of the trial group were lower than those of the control group （P＜0.01）. The cure rate and effective rate of TCM syndrome of the trial group were significantly higher than those of the control group （P＜0.01）. There was no significant difference in blood routine， urine routine， liver function， kidney function between groups before and after treatment （P＞0.05）， and no serious adverse events occured in both groups. ConclusionBairui Granules showed clinical effectiveness in the treatment of acute pharyngitis of wind-heat syndrome， and it could significantly improve the clinical symptoms， accelerate the disappearance time of sore throat with good safety.

[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 â ¡b clinical trial].

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.

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 / 中国中药杂志

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.

Efficacy and safety of Lian-Ju-Gan-Mao capsules for treating the common cold with wind-heat syndrome: study protocol for a randomized controlled trial.

BACKGROUND: The common cold is a common and frequent respiratory disease mainly caused by viral infection of the upper respiratory tract. Chinese herbal medicine has been increasingly prescribed to treat the common cold; however, there is a lack of evidence to support the wide utility of this regimen. This protocol describes an ongoing phase II randomized controlled clinical trial, based on the theory of traditional Chinese medicine (TCM), with the objective of evaluating the efficacy and safety of Lian-Ju-Gan-Mao capsules (LJGMC), a Chinese patent medicine, compared with placebo in patients suffering from the common cold with wind-heat syndrome (CCWHS). METHODS/DESIGN: This is a multicenter, randomized, double-blind, placebo-controlled phase II clinical trial. A total of 240 patients will be recruited and randomly assigned to a high-dose group, medium-dose group, low-dose group, and placebo-matched group in a 1:1:1:1 ratio. The treatment course is 3 consecutive days, with a 5-day follow-up. The primary outcome is time to all symptoms' clearance. Secondary outcomes include time to the disappearance of primary symptoms and each secondary symptom, time to fever relief, time to fever clearance, and change in TCM symptom and sign scores. DISCUSSION: This trial is a well-designed study according to principles and regulations issued by the China Food and Drug Administration (CFDA). The results will provide high-quality evidence on the efficacy and safety of LJGMC in treating CCWHS and help to optimize the dose for the next phase III clinical trial. Moreover, the protocol presents a detailed and practical methodology for future clinical trials of drugs developed based on TCM. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR-IPR-15006504 . Registered on 4 June 2015.

A safety and effectiveness research of Yinhua Pinggan granule of Qingjie Xuantou lung defense prescription for treatment of patients with upper respiratory tract infection accompanied by syndrome of pathogen stagnated in lung-defense phase: a randomized double blinded, positive drug parallel controlled and multicentric clinical trial / 中国中西医结合急救杂志

Objective To evaluate the safety and efficacy of Yinhua Pinggan granule of Qingjie Xuantou lung defense prescription in the treatment of patients with upper respiratory tract infection accompanied by traditional Chinese medicine (TCM) syndrome of pathogen stagnated in lung-defense phase and to explore the best effective dose.Methods A randomized double blinded, positive drug parallel controlled and multicentric clinical trial was conducted, 270 patients with upper respiratory infection were collected from the First Affiliated Hospital of Zhejiang Chinese Medical University, Affiliated Hospital of Jiangxi Medical University, the Second Affiliated Hospital of Tianjin University of TCM, Tongde Hospital of Zhejiang Province, and Fujian Province Institute of TCM, after screening only 242 cases were consistent with the criteria of enrollment into the Per-Protocol Set (PPS) population, and they were divided into three groups: high dose observation group (82 cases), low dose observation group (79 cases) and control group (81 cases). The high and low dose observation groups were treated with Yinhua Pinggan granule (5 g per bag), high dose means once 1 bag orally taken 3 times a day, low dose indicates once 1 bag taken twice a day; the control group was treated with Yinqiao Jiedu granule (5 g per bag) once 1 bag, 3 times a day; the curative effects of the above groups were all evaluated after consecutive oral administration of the drug respectively for 1 therapeutic course (3 days). The main efficacy evaluation indexes included the TCM syndrome total score and the total score of main symptoms of upper respiratory tract infection; the secondary efficacy evaluation indexes included the situations of patients with different scores of main symptoms of fever and chills, and of disappearance of TCM symptoms; the clinical comprehensive therapeutic effect and the changes of proportion of neutrophils were observed and the safety of drugs was evaluated.Results In PPS population, after treatment the TCM syndrome total score and the total score of main symptoms in the control group and the high and low dose observation groups were all significantly lower than those before treatment, on the 3rd day statistical significant differences were shown (4.4±3.9 vs. 15.5±4.6, 3.7±3.2 vs. 15.0±4.3, 3.0±2.7 vs. 15.2±3.9, 2.8±2.6 vs. 9.7±2.7, 2.3±2.1 vs. 9.5±2.5, 2.0±1.9 vs. 9.6±2.4, respectively, all P < 0.01). After treatment for 1 day, the numbers of patients with 6 score in the control group and the high and low dose observation groups were reduced significantly compared with those before treatment in main symptoms of fever with chills (7 vs. 32 cases, 6 vs. 31 cases, 4 vs. 28 cases, respectively); 3 days after treatment, compared with those before treatment, the numbers of patients with main symptoms of fever with chills score being 0 were significantly increased in the above three groups (65, 73, 77 cases vs. 0 cases, respectively), the numbers of patients with the score being 3 were significantly decreased (16 vs. 47 cases, 5 vs. 46 cases, 5 vs. 52 cases, respectively); the control and high dose observation group had no patients with the score being 6, there was only 1 case with the score being 6 in the low dose observation group. The results showed that the treatments of high and low dose observation groups and the control group all could alleviate the clinical symptoms, and the changes of numbers of patients with the scoresbeing 0 and 3 in high and low dose groups were more significant than those in the control group (respectively 73, 77 vs. 65 cases, 5, 5 vs. 16 cases, allP < 0.05), showing that the antipyretic effect of Yinhua Pinggan granule was superior to that of the Yinqiao Jiedu granule. The disappearance rates of fever with chills symptoms in high and low dose observation groups were significantly higher than that in the control group [respectively 93.9% (77/82), 92.4% (73/79) vs. 80.2% (65/81), allP < 0.05]. The TCM syndrome cure and obvious effect rate and effective rate in high and low dose observation groups were higher than those in the control group [respectively 87.80% (72/82), 79.75% (63/79) vs. 74.07% (60/81) and 98.78% (81/82), 96.20% (76/79) vs. 96.30% (78/81)]; the cure and marked effective rate and effective rate of controlling symptoms of upper respiratory tract infection in high and low dose observation groups were higher than those in the control group [respectively 78.05% (64/82), 74.68% (59/79) vs. 65.43% (78/81) and 98.78% (81/82), 96.20% (76/79) vs. 96.30% (78/81)], comparisons of efficacy among the three groups possessed clinical practical significance, but the differences were not statistically significant (allP > 0.05). The percentages of neutrophils in high and low dose observation groups and control group were significantly lower than those before treatment (respectively 0.61±0.08 vs. 0.63±0.08, 0.62±0.08 vs. 0.64±0.08, 0.61±0.09 vs. 0.64±0.09, allP < 0.05). Yinhua Pinggan granule was safe in the prescribed course of treatment and range of therapeutic dose.Conclusions Yinhua Pinggan granule is a safe and effective drug in the treatment of patients with upper respiratory tract infection accompanied by syndrome of pathogen stagnated in lung-defense phase.