scholarly journals Total Glucosides of Paeony Capsule Plus Compound Glycyrrhizin Tablets for the Treatment of Severe Alopecia Areata in Children: A Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-5 ◽  
Author(s):  
Dingquan Yang ◽  
Jingwen Zheng ◽  
Yuming Zhang ◽  
Yueli Jin ◽  
Chaonan Gan ◽  
...  
Keyword(s):  
Treatment Group ◽  
Adverse Events ◽  
Alopecia Areata ◽  
Statistical Difference ◽  
Controlled Trial ◽  
Effective Rate ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Total Glucosides Of Paeony

Total glucosides of paeony capsule (TGPC) and compound glycyrrhizin tablets (CGT) are plant extracts of glycosides. We conducted this study to examine the efficacy and safety of TGPC plus CGT for severe alopecia areata in children. 117 subjects were randomly allocated into TGPC plus CGT group or CGT group. For consecutive 12 months, subjects were given oral TGPC and CGT or oral CGT alone. The outcome measures included score of alopecia areata severity, effective rate, and adverse events observed in the 3rd, 6th, and 12th month. We found that the scores of alopecia areata severity of both groups were significantly reduced, and the scores of treatment group were lower than those of control group; for effective rate, there was no statistical difference between the two groups in the 3rd month, while in the 6th and 12th months the treatment group was superior compared with control group; the incidence rate of adverse events between the two groups was not statistically different, and no severe adverse events were observed. In conclusion, TGPC plus CGT appears effective and safe for severe alopecia areata in children.

scholarly journals Efficacy and Safety of Maxing Xianchang Su in the Treatment of Functional Constipation: A Randomized Controlled Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Mi Li ◽  
Lijuan Zhao ◽  
Li Ma ◽  
Wen Zhang ◽  
Hua Huang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Controlled Trial ◽  
Functional Constipation ◽  
Oral Solution ◽  
Controlled Study ◽  
Symptom Improvement ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled

Background. Functional constipation (FC) is one of the prevalent gastrointestinal disorders that affect people of all ages. Long-term FC has significant effects on the quality of life of patients. Although commonly used drugs have reliable short-term effects, they are easily addictive and have side effects. Therefore, pursuing a convenient drug-food homogenous program is critical for FC patients. Maxing Xianchang Su is a functional food based on traditional Chinese medicine. To investigate the efficacy and safety of Maxing Xianchang Su in FC treatment, we conducted a randomized controlled trial. Methods. We carried out a prospective multicenter randomized parallel controlled study in three hospitals in Jiangsu Province, China, from January 2020 to March 2021, which included 206 FC patients. All patients were arbitrarily assigned into a treatment group and a control group at a ratio of 1 : 1; 103 cases in each group. The treatment group was given oral Maxing Xianchang Su, whereas the control group was treated with lactulose oral solution. The course of treatment was two weeks. The two groups of patients were evaluated after six weeks for symptom improvement before and after taking the drug. Furthermore, the safety of Maxing Xianchang Su was assessed. Results. Both groups of patients successfully completed the study without shedding cases. The effective rates of the treatment group and control group after two weeks were 90.6% and 67.0%, respectively. The treatment group had a better curative effect than the control group ( P < 0.05 ). The symptom score of the two groups improved compared with that before the treatment. The difference between the two groups was statistically significant ( P < 0.05 ). During the treatment process, neither group experienced abnormal changes in blood lipid, blood glucose, routine hematuria, or liver and kidney functions. There were no adverse reactions in both groups. Conclusion. Maxing Xianchang Su has a positive effect on FC treatment with reliable mid-term effect and a high level of safety.

Efficacy and Safety of Non-Steroidal Anti-Androgens in Patients with Metastatic Prostate Cancer: Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 15 (1) ◽  
pp. 34-47 ◽  
Author(s):  
Muhammed Rashid ◽  
Madhan Ramesh ◽  
K. Shamshavali ◽  
Amit Dang ◽  
Himanshu Patel ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Quality Assessment ◽  
Cochrane Library ◽  
Control Group ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Significant Difference

Background: Prostate cancer (PCa) is the sixth primary cause of cancer death. However, conflicts are present about the efficacy and safety of Non-steroidal anti-androgens (NSAA) for its treatment. The aim of this study was to assess the efficacy and safety of NSAAs versus any comparator for the treatment of advanced or metastatic PCa (mPCa). Methodology: MEDLINE and the Cochrane Library were searched. References of included studies and clinicaltrials.gov were also searched for relevant studies. Only English language studies after 1990 were considered for review. Randomized controlled trials (RCTs) examining the efficacy and safety of NSAAs as compared with any other comparator including surgery or chemotherapy in mPCa patients were included. The outcomes include efficacy, safety and the tolerability of the treatment. The Cochrane Risk of Bias Assessment Tool was used for quality assessment. Two authors were independently involved in the selection, extraction and quality assessment of included studies and disagreements were resolved by discussion or by consulting a third reviewer. Results: Fifty-eight out of 1307 non-duplicate RCTs with 29154 patients were considered for the review. NSAA showed significantly better progression-free survival [PFS] (Hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.46-0.78; P=0.0001), time to distant metastasis or death [TTD] (HR, 0.80; 95% CI 0.73-0.91; p<0.0001), objective response (Odds ratio [OR], 1.64; 95% CI 1.06-2.54; P=0.03) and clinical benefits (OR, 1.33; 95% CI 1.08-1.63; P=0.006) as compared to the control group. There was no significant difference observed between the groups in terms of overall survival (HR, 0.95; 95%CI, 0.87-1.03; P=0.18) and time to progression (HR, 0.93; 95% CI 0.77-1.11; P=0.43). Treatment-related adverse events were more with the NSAA group, but the discontinuation due to lack of efficacy reason was 43% significantly lesser than the control group in patients with mPCa. Rest of the outcomes were appeared to be non-significant. Conclusion: Treatment with NSAA was appeared to be better efficacious with respect to PFS, TTD, and response rate with considerable adverse events when compared to the control group in patients with metastatic PCa.

The Effect of Lavender Oil on Perioperative Pain, Anxiety, Depression, and Sleep after Microvascular Breast Reconstruction: A Prospective, Single-Blinded, Randomized, Controlled Trial

2021 ◽  
Author(s):  
Ronnie L. Shammas ◽  
Caitlin E. Marks ◽  
Gloria Broadwater ◽  
Elliot Le ◽  
Adam D. Glener ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Breast Reconstruction ◽  
Controlled Trial ◽  
Depression Scale ◽  
Control Group ◽  
Lavender Oil ◽  
Entire Cohort ◽  
Randomized Controlled ◽  
Anxiety Depression

Abstract Background Psychosocial distress, depression, or anxiety can occur in up to 50% of women after a breast cancer diagnosis and mastectomy. The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction. Methods This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or placebo (coconut oil) throughout their hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards–Campbell Sleep Questionnaire, and the visual analogue scale. Results Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression (p = 0.21), sleep (p = 0.86), or pain (p = 0.30) scores. No adverse events (i.e., allergic reaction) were captured, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores (p < 0.001), while depression scores were significantly higher postoperatively as compared with preoperatively (p = 0.005). Conclusion In the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

Water exchange-assisted vs. carbon dioxide-insufflated single-balloon enteroscopy: randomized controlled trial

Endoscopy ◽  
2021 ◽  
Author(s):  
Shaopeng Liu ◽  
Tao Dong ◽  
Yupeng Shi ◽  
Hui Luo ◽  
Xianmin Xue ◽  
...  
Keyword(s):  
Carbon Dioxide ◽  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Water Exchange ◽  
Controlled Trial ◽  
Control Group ◽  
Balloon Enteroscopy ◽  
Randomized Controlled ◽  
Single Balloon ◽  
Single Balloon Enteroscopy

<b>Background and study aims</b> Single-balloon enteroscopy (SBE) is a valuable but difficult modality for the diagnosis and treatment of small-bowel diseases. The water exchange (WE) method has the advantage of facilitating intubation during colonoscopy. Here, we evaluated the effects of WE on procedure-related variables related to SBE. <b>Patients and methods</b> This randomized controlled trial was conducted in a tertiary-care referral center in China. Patients with attempt at total enteroscopy (ATE) were randomly allocated to undergo WE-assisted (WE group) or carbon dioxide-insufflated enteroscopy (CO<sub>2</sub> group). All patients were planned to undergo both antegrade and retrograde procedures. The primary outcome was the total enteroscopy rate (TER). Secondary outcomes included maximal insertion depth, positive findings, procedural time and adverse events. <b>Results</b> In total, 110 patients were enrolled, with 55 in each group. Baseline characteristics between the two groups were comparable. TER was achieved in 58.2% (32/55) of the WE group and 36.4% (20/55) of the control group (p=0.022). The estimated intubation depth was 521.2±101.4 cm in the WE group and 481.6±95.2 cm in the CO<sub>2</sub> group (p=0.037). The insertion time was prolonged in the WE group compared with CO<sub>2</sub> group (178.9±45.1 min vs. 154.2±27.6 min, p<0.001). Endoscopic findings and adverse events were comparable between the two groups. <b>Conclusions</b> The WE method improved TER and increased intubation depth during SBE. The use of WE did not increase complications of enteroscopy. Clinical trial registation: https://clinicaltrials.gov/， NCT01942863.

scholarly journals Evaluation on immediate analgesic efficacy and safety of Kai-Hou-Jian spray (children’s type) in treating sore throat caused by acute pharyngitis and tonsillitis in children: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Yan-ning Ma ◽  
Cheng-liang Zhong ◽  
Si-yuan Hu ◽  
Qiu-han Cai ◽  
Sheng-xuan Guo
Keyword(s):  
Clinical Trial ◽  
Sore Throat ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Effective Rate ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Acute Pharyngitis ◽  
Randomized Controlled ◽  
Parallel Group

Abstract Background Acute pharyngitis and tonsillitis are common respiratory diseases for which children seek medical care. Their main clinical manifestation is sore throat which interferes with patients’ quality of life. However, there is no proven effective or safe method to treat it. It is necessary to find an excellent strategy to reduce sore throat and reduce the burden of acute illness. We designed the randomized controlled trial with the characteristics of traditional Chinese medicine (TCM) to determine the clinical positioning of Kai-Hou-Jian spray (children’s type) (KHJS) through evidence-based research. This trial aims to evaluate the immediate analgesic efficacy of KHJS on sore throat caused by acute pharyngitis and tonsillitis (wind-heat syndrome/heat exuberance in lung and stomach syndrome) in children and to observe its safety. Methods/design This is a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. It will include 240 children with acute pharyngitis/tonsillitis from 7 study sites across China. All participants are randomly assigned to two parallel treatment groups, one with KHJS and the other with placebo sprays, for 5 consecutive days. The primary outcome is the time of analgesic onset. Secondary outcomes include duration of analgesic effect, area under time curve of 0–3 h Wong-Baker FACES Pain Rating Scale (WBS) score (AUC0-3 h), rate of analgesic onset, rate of disappearance of sore throat, changes of WBS score (in days), effective rate of pharyngeal signs, and effective rate of TCM syndrome. The incidence of adverse events during the trial is the primary safety outcome. In addition, vital signs and laboratory tests before and after medication are monitored. Discussion To our knowledge, this will be the first clinical trial to explore the immediate analgesic efficacy of a Chinese patent medicine spray for acute pharyngitis/tonsillitis induced sore throat in children in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it prove the efficacy and safety of KHJS in the treatment of sore throat caused by acute pharyngitis/tonsillitis in children, but it might also provide evidence for the treatment of acute sore throat with Chinese herbal medicine. Trial registration A multicenter, randomized, double-blind, very low-dose, parallel controlled trial for the immediate analgesic effect and safety of Kai-Hou- Jian spray (children's type) in the treatment of sore throat caused by acute pharyngitis and tonsillitis in children. Chinese Clinical Trial Registry ChiCTR2000031599. Registered on 5 April 2020

scholarly journals Efficacy and safety of duloxetine for postoperative pain after total knee arthroplasty in centrally sensitized patients: study protocol for a randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Shicheng Wang ◽  
Wensheng Wang ◽  
Long Shao ◽  
Jing Ling
Keyword(s):  
Clinical Trial ◽  
Total Knee Arthroplasty ◽  
Randomized Controlled Trial ◽  
Pain Control ◽  
Controlled Trial ◽  
Control Group ◽  
Efficacy And Safety ◽  
Randomized Controlled ◽  
Total Knee ◽  
Postoperative Residual

Abstract Background Postoperative residual knee pain after total knee arthroplasty (TKA) is a significant factor that contributes to patient dissatisfaction. Patients with preoperative central sensitization (CS) may be more susceptible to unexplained chronic pain after TKA, and duloxetine has been reported to be effective in post-TKA pain control in patients with CS. However, there remains limited evidence to support this off-label use in routine clinical practice. Hence, we designed this randomized, placebo-controlled, triple-blind clinical trial to evaluate the effects of preoperative screening and targeted duloxetine treatment of CS on postoperative residual pain compared with the care-as-usual control group. Methods This randomized controlled trial includes patients with knee osteoarthritis on a waiting list for primary unilateral TKA. Patients with preoperative CS will be randomly allocated to the perioperative duloxetine treatment group (duloxetine group) or the care-as-usual control group (placebo group). Patients in the duloxetine group will receive a half-dose of preemptive duloxetine (30 mg/day) for a week before surgery and a full-dose of duloxetine (60 mg/day) for six weeks after surgery. The primary outcome is the intensity of residual pain at six months after TKA, including the visual analogue scale, 11-point numeric rating scale, the sensory dimension of the brief pain inventory, and the pain subscale of the Knee injury and Osteoarthritis Outcome Score. The secondary outcome measures will include the pain and function related outcomes. All of the patients will be followed up at one, three, and six months after surgery. All adverse events will be recorded and immediately reported to the primary investigator and ethics committee to decide if the patient needs to drop out from the trial. Discussion This clinical trial will convey the latest evidence of the efficacy and safety of the application of duloxetine in postoperative pain control in CS patients who are scheduled for TKA. The study results will be disseminated at national and international conferences and published in peer-reviewed journals. Trial registration Chinese Clinical Trial Registry (http://www.chictr.org.cn) registration number: ChiCTR2000031674. Registered 07 April 2020.

2021 Mark Coventry Award: Use of a smartphone-based care platform after primary partial and total knee arthroplasty: a prospective randomized controlled trial

2021 ◽  
Vol 103-B (6 Supple A) ◽  
pp. 3-12 ◽  
Author(s):  
David A. Crawford ◽  
Paul J. Duwelius ◽  
Michael A. Sneller ◽  
Michael J. Morris ◽  
Jason M. Hurst ◽  
...  
Keyword(s):  
Emergency Department ◽  
Treatment Group ◽  
Knee Arthroplasty ◽  
Care Management ◽  
Controlled Trial ◽  
Emergency Department Visits ◽  
Control Group ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Total Knee

Aims The purpose is to determine the non-inferiority of a smartphone-based exercise educational care management system after primary knee arthroplasty compared with a traditional in-person physiotherapy rehabilitation model. Methods A multicentre prospective randomized controlled trial was conducted evaluating the use of a smartphone-based care management system for primary total knee arthroplasty (TKA) and partial knee arthroplasty (PKA). Patients in the control group (n = 244) received the respective institution’s standard of care with formal physiotherapy. The treatment group (n = 208) were provided a smartwatch and smartphone application. Early outcomes assessed included 90-day knee range of movement, EuroQoL five-dimension five-level score, Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS JR) score, 30-day single leg stance (SLS) time, Time up and Go (TUG) time, and need for manipulation under anaesthesia (MUA). Results Overall, 90-day mean flexion was not significantly different between the control (121° (SD 11.7°)) and treatment groups (121o; p = 0.559); 90-day mean SLS was 22.7 seconds (SD 9.8) in controls and 24.3 seconds (SD 20.8) in treatment (p = 0.519); 90-day mean TUG times were 10.1 seconds (SD 4.8) in control and 9.3 seconds (SD 3.3) in treatment (p = 0.139). Mean KOOS JR scores were significantly different between control group (73.6 (SD 13.4)) and treatment group (70.4 (SD 12.6); p = 0.026). MUAs were performed in nine (3.7%) patients in the control group and four (1.9%) in the treatment group (p = 0.398). Physiotherapy was performed by 230 (94.4%) of control group and 123 (59.3%) of treatment group (p < 0.001). There were no significant differences between groups in postoperative urgent care visits, or readmissions within 90 days, with significantly fewer emergency department visits in the treatment group (16 (8.2%) vs five (2.5%), p = 0.014). Conclusion The use of the smartwatch/smartphone care platform demonstrated non-inferiority of clinically significant outcomes to traditional care models, while requiring significantly less postoperative physiotherapy and fewer emergency department visits. This platform could aid in decreasing postoperative costs, while improving patient engagement and communication with the healthcare team. Cite this article: Bone Joint J 2021;103-B(6 Supple A):3–12.

Pulsed Ultrasounds Reduce Pain and Disability, Increasing Rib Fracture Healing, in a Randomized Controlled Trial

Pain Medicine ◽  
2018 ◽  
Vol 20 (10) ◽  
pp. 1980-1988
Author(s):  
Norberto Santana-Rodríguez ◽  
Bernardino Clavo ◽  
Pedro Llontop ◽  
María D Fiuza ◽  
Joaquín Calatayud-Gastardi ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Controlled Trial ◽  
Pain Medication ◽  
Control Group ◽  
Work Activity ◽  
Randomized Controlled ◽  
Medication Intake ◽  
Bone Callus

AbstractIntroductionRib fractures are an important health issue worldwide, with significant, pain, morbidity, and disability for which only symptomatic treatment exists.ObjectivesBased on our previous experimental model, the objective of the current study was to assess for the first time whether pulsed ultrasound (PUS) application could have beneficial effects on humans.MethodsProspective, double-blinded, randomized, controlled trial of 51 patients. Four were excluded, and 47 were randomized into the control group (N = 23) or PUS group (N = 24). The control group received a PUS procedure without emission, and the PUS group received 1 Mhz, 0.5 W/cm2 for 1 min/cm2. Pain level, bone callus healing rate, physical and work activity, pain medication intake, and adverse events were blindly evaluated at baseline and one, three, and six months.ResultsThere were no significant differences at baseline between groups. PUS treatment significantly decreased pain by month 1 (P = 0.004), month 3 (P = 0.005), and month 6 (P = 0.025), significantly accelerated callus healing by month 1 (P = 0.013) and month 3 (P < 0.001), accelerated return to physical activity by month 3 (P = 0.036) and work activity (P = 0.001) by month 1, and considerably reduced pain medication intake by month 1 (P = 0.057) and month 3 (P = 0.017). No related adverse events were found in the PUS group.ConclusionsThis study is the first evidence that PUS treatment is capable of improving rib fracture outcome, significantly accelerating bone callus healing, and decreasing pain, time off due to both physical activity and convalescence period, and pain medication intake. It is a safe, efficient, and low-cost therapy that may become a new treatment for patients with stable rib fractures.

Clustered Randomized Controlled Trial of a Hand Hygiene Intervention Involving Pocket-Sized Containers of Alcohol-Based Hand Rub for the Control of Infections in Long-Term Care Facilities

2011 ◽  
Vol 32 (1) ◽  
pp. 67-76 ◽  
Author(s):  
Wing Kin Yeung ◽  
Wai San Wilson Tam ◽  
Tze Wai Wong
Keyword(s):  
Treatment Group ◽  
Hand Hygiene ◽  
Controlled Trial ◽  
Control Group ◽  
Term Care ◽  
Randomized Controlled ◽  
Serious Infections ◽  
Care Facilities ◽  
To Receive

Objective.To investigate the effectiveness of a multifaceted hand hygiene program involving the use of pocket-sized containers of antiseptic gel in long-term care facilities (LTCFs) with elderly residents.Methods.In this clustered randomized controlled trial, Hong Kong LTCFs for elderly persons were recruited via snowball sampling. Staff hand hygiene adherence was directly observed, and residents' infections necessitating hospitalization were recorded. After a 3-month preintervention period, LTCFs were randomized to receive pocket-sized containers of alcohol-based gel, reminder materials, and education for all HCWs (treatment group) or to receive basic life support education and workshops for all healthcare workers (HCWs) (control group). A 2-week intervention period (April 1-15, 2007) was followed by 7 months of postintervention observations.Results.In the 3 treatment LTCFs, adherence to hand rubbing increased from 5 (1.5%) of 333 to 233 (15.9%) of 1,465 hand hygiene opportunities (P = .001) and total hand hygiene adherence increased from 86 (25.8%) of 333 to 488 (33.3%) of 1,465 opportunities (P = .01) after intervention; the 3 control LTCFs showed no significant change. In the treatment group, the incidence of serious infections decreased from 31 cases in 21,862 resident-days (1.42 cases per 1,000 resident-days) to 33 cases in 50,441 resident-days (0.65 cases per 1,000 resident-days) (P = .002), whereas in the control group, it increased from 16 cases in 32,726 resident-days (0.49 cases per 1,000 resident-days) to 85 cases in 81,177 resident-days (1.05 cases per 1,000 resident-days) (P = .004). In the treatment group, the incidence of pneumonia decreased from 0.91 to 0.28 cases per 1,000 resident-days (P = .001) and the death rate due to infection decreased from 0.37 to 0.10 deaths per 1,000 resident-days (P = .01); the control group revealed no significant change.Conclusions.A hand hygiene program involving the use of pocket-sized containers of antiseptic gel and education could effectively increase adherence to hand rubbing and reduce the incidence of serious infections in LTCFs with elderly residents.

scholarly journals Evaluation on Immediate Analgesic Efficacy and Safety of Kai-Hou-Jian Spray (Children 'S Type) In Treating Sore Throat Caused By Acute Pharyngitis and Tonsillitis In Children: Study Protocol For A Randomized Controlled Trial

2021 ◽  
Author(s):  
Yan-ning Ma ◽  
Cheng-liang Zhong ◽  
Siyuan Hu ◽  
Qiu-han Cai ◽  
Sheng-xuan Guo
Keyword(s):  
Randomized Controlled Trial ◽  
Sore Throat ◽  
Rating Scale ◽  
Controlled Trial ◽  
Analgesic Efficacy ◽  
Effective Rate ◽  
Efficacy And Safety ◽  
Acute Pharyngitis ◽  
Randomized Controlled ◽  
Parallel Group

Abstract Background: Acute pharyngitis and tonsillitis are common respiratory diseases for which children seek medical care. Their main clinical manifestation is sore throat which interferes with patients’ quality of life. However, there is no proven effective or safe method to treat it. It is necessary to find an excellent strategy to reduce sore throat and reduce the burden of acute illness. We designed the randomized controlled trial with the characteristics of traditional Chinese medicine (TCM) to determine the clinical positioning of Kai-Hou-Jian spray (children 's type) (KHJS) through evidence-based research. This trial aims to evaluate the immediate analgesic efficacy of KHJS on sore throat caused by acute pharyngitis and tonsillitis (wind-heat syndrome/heat exuberance in lung and stomach syndrome) in children, and to observe its safety. Methods/design: This is a prospective, multicenter, randomized, double-blind, parallel-group, placebo-controlled trial. It will include 240 children with acute pharyngitis/tonsillitis from 7 study sites across China. All participants are randomly assigned to two parallel treatment groups, one with KHJS and the other with placebo sprays, for 5 consecutive days. The primary outcome is the time of analgesic onset. Secondary outcomes include duration of analgesic effect, area under time curve of 0-3 hours Wong-Baker FACES Pain Rating Scale (WBS) score (AUC0-3h), rate of analgesic onset, rate of disappearance of sore throat, changes of WBS score (in days), effective rate of pharyngeal signs, and effective rate of TCM syndrome. The incidence of adverse events during the trial is the primary safety outcome. In addition, vital signs and laboratory tests before and after medication are monitored.Discussion: To our knowledge, this will be the first clinical trial to explore the immediate analgesic efficacy of a Chinese patent medicine spray for acute pharyngitis/tonsillitis induced sore throat in children in a multicenter, randomized, double-blinded, parallel-group, placebo-controlled manner. Not only might it prove the efficacy and safety of KHJS in the treatment of sore throat caused by acute pharyngitis/tonsillitis in children, but it might also provide evidence for the treatment of acute sore throat with Chinese herbal medicine.Trial registration: ChiCTR2000031599. Registered on 5 April 2020, http://www.chictr.org.cn/showproj.aspx?proj=50385

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