scholarly journals Treatment of Common Cold Patients with the Shi-Cha Capsule: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Escalation Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-9 ◽  
Author(s):  
Jing Chang ◽  
Shou-Jin Dong ◽  
Bin She ◽  
Rui-Ming Zhang ◽  
Mao-Bin Meng ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Symptom Score ◽  
Common Cold ◽  
Symptom Duration ◽  
Double Blind ◽  
Main Symptom ◽  
Minor Symptom ◽  
Group A ◽  
Group B

This study was designed to determine the therapeutic efficacy and safety of the Shi-cha capsule, a Chinese herbal formula, in the treatment of patients with wind-cold type common cold. In our multi-center, prospective, double-blind, randomized, placebo-controlled, dose-escalation trial, patients with wind-cold type common cold received 0.6 g of Shi-cha capsule plus 0.6 g placebo (group A), 1.2 g of Shi-cha capsule (group B), or 1.2 g placebo (group C), three times daily for 3 days and followed up to 10 days. The primary end point was all symptom duration. The secondary end points were main symptom duration, minor symptom duration, the changes in cumulative symptom score, main symptom score, and minor symptom score 4 days after the treatment, as well as adverse events. A total of 377 patients were recruited and 360 met the inclusive criteria; 120 patients constituted each treatment group. Compared with patients in group C, patients in groups A and B had significant improvement in the all symptom duration, main symptom duration, minor symptom duration, as well as change from baseline of cumulative symptom score, main symptom score, and minor symptom score at day 4. The symptom durations and scores showed slight superiority of group B over group A, although these differences were not statistically significant. There were no differences in adverse events. The Shi-cha capsule is efficacious and safe for the treatment of patients with wind-cold type common cold. Larger trials are required to fully assess the benefits and safety of this treatment for common cold.

ENDOGENOUS CIRCADIAN RHYTHM OF FIBRINOLYTIC PARAMETERS

1987 ◽  
Author(s):  
M Köhler ◽  
C Mivashita ◽  
A Friedl ◽  
S Littbarski ◽  
M Heiden ◽  
...  
Keyword(s):  
Circadian Rhythm ◽  
Placebo Group ◽  
Fibrinolytic Activity ◽  
Controlled Trial ◽  
Double Blind ◽  
Endogenous Circadian Rhythm ◽  
Test Kit ◽  
Group A ◽  
Group B ◽  
Male Subjects

Recently, the fibrinolytic system was shown to be dependent on complex interactions of several proteins for which specific test systems have been developed. We report on the results in placebo groups of two drug trials which strongly suggest an endogenous circadian rhythm of these parameters. In the first trial, 6 male subjects consecutively received either different heparins or placebo (group A). In a double blind placebo controlled trial, 10 male subjects received either DDAVP or placebo (group B). Blood was obtained before (7:30 a.m.), and 1, 2, 3, 4, 6, 9, 12 h and, only in group A, 15 and 24 h after the injection (8:00 a.m.). Euglobulin precipitate (EP) was prepared immediately after centrifugation. Fibrinolytic activity (FA) and t-PA activity were measured according to Astrup and Miillertz (1952) and Verheijen et al.(l982), respectively. t-PA antigen was measured using a kit from Biopool, Umea. t-PA-inhibitor (INH) was determined using a commercial kit from Kabivitrum and the method described by Chmielewska et al.(l983). Statistical analysis was performed using ANOVA (t-PA antigen) and Kruskal-Wal1is test.Results: In group A, t-PA antigen was significantly higher in the morning than in the evening. In contrast, t-PA activity and FA were low in the morning and gradually increased and reached maxima at 8 p.m. and 11 p.m., respectively. In group B, the same pattern was observed and all diurnal variations were statistically significant. Higher levels of t-PA-INH and t-PA-antigen were observed in the morning, and lower levels of t-PA and fibrinolytic activity. A reversed pattern was seen in the evening ( 8 p.m.). The two different methods for t-PA measurements showed the same variation^ although a c.lO-fold higher level was determined using the Kabivitrum test kit.

scholarly journals Comparison of gabapentin and oxycodone-acetaminophen used for pre-emptive analgesia in patients undergoing double-port thoracoscopic pulmonary surgery: a randomized, double-blind, controlled trial.

2019 ◽  
Author(s):  
Li Li ◽  
XiJuan Li ◽  
JinMei Shen ◽  
LiJun Zhou
Keyword(s):  
Chronic Pain ◽  
Adverse Events ◽  
Controlled Trial ◽  
Opioid Consumption ◽  
Control Group ◽  
Double Blind ◽  
Pulmonary Surgery ◽  
Post Operative Pain ◽  
Group A ◽  
Group B

Abstract Background This study was designed to determine whether gabapentin is not inferior to the oxycodone-acetaminophen group used as pre-emptive analgesia in reducing post-operative pain. The post-operative pain of patients undergoing thoracoscopic pulmonary surgery, a routine operation procedure, is also a clinical problem that urgently needs to be further explored. We hypothesized that gabapentin is not inferior to oxycodone-acetaminophen.Methods Ninety patients were randomly divided into group A,n=30; group B,n=30; and group C,n=30. Patients in group A received oral gabapentin (300 mg) 2 h before surgery, similarly patients in group B received oral oxycodone-acetaminophen (330mg);Group C did not take any oral drugs; all patients were given self-controlled intravenous analgesia after surgery. NRS scores post-operative, opioid consumption 48 hours post-operative, analgesic-related adverse events, post-operative chronic pain after 2 months, were recorded.Results The NRS scores and opioid consumption 48 hours post-operative of intervention groups were significantly lower than the control group, and did not increase analgesic-related adverse events. The incidence of chronic pain 2 months post-operative in groups A and B was significantly lower than group C.Conclusion Oral gabapentin and oxycodone-acetaminophen alleviated the pain post-operative, reduced opioid consumption post-operative,promoted the recovery.

Pregabalin As A Premedicant To Attenuate Pressor Response In Patients Undergoing Laparoscopic Cholecystectomy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

2020 ◽  
Vol 11 (3) ◽  
pp. 3418-3423
Author(s):  
Sweety Agrawal ◽  
Shubdha Bhagat ◽  
Pratibha Deshmukh ◽  
Amol Singham
Keyword(s):  
Laparoscopic Cholecystectomy ◽  
Pressor Response ◽  
Controlled Study ◽  
Double Blind ◽  
Co2 Insufflation ◽  
Ramsay Sedation Scale ◽  
Minute Interval ◽  
Group A ◽  
Group B ◽  
Induction Of Anaesthesia

The present study was done to evaluate the ability of oral pregabalin to attenuate the pressor response to airway instrumentation in patients undergoing laparoscopic cholecystectomy under general anesthesia. Sixty-four adult patients aged between 25-55 year of either gender belonging to ASA-1 or ASA2 physical status weighing 50-70 kg were enrolled in this study. Thirty-two patients each were randomized to group A, or group B. Patients in group A received tablet Pregabalin (150mg) and those in group B received placebo orally one hour before induction of anaesthesia. Heart rate, blood pressure, and sedation were assessed preoperatively before giving the tablets and after 30 minutes, and just before induction of anaesthesia. Intraoperative, pulse rate, mean arterial pressure, ECG in the lead II, SPO2 and ETCO2 were monitored. All the above parameters were noted during laryngoscopy and intubation, 3 minutes after CO2 insufflation, and then at every 10-minute interval till the end of surgery. These parameters were also recorded after extubating the patient. The Ramsay sedation scale was used to assess the sedation at the baseline, one hour after drug intake , one hour after extubation and 4 hour after surgery. Any adverse effects in the postoperative period were recorded. The result of our study shows that pre-emptive administration of oral pregabalin 150 mg significantly reduced the pressor response at the time of laryngoscopy and intubation, after CO2 insufflation and just after extubation. We conclude that oral pregabalin premedication is effective in successful attenuation of hemodynamic pressor response to laryngoscopy, intubation and pneumoperitoneum in patients undergoing laparoscopic cholecystectomy

Pharmacokinetics and Safety Assessment of Anti-HIV Dapivirine Vaginal Microbicide Rings with Multiple Dosing

2020 ◽  
Author(s):  
Lungwani Muungo
Keyword(s):  
Ex Vivo ◽  
Oral Treatment ◽  
Plasma Concentrations ◽  
Vaginal Ring ◽  
Vaginal Fluid ◽  
Cervical Tissue ◽  
Double Blind ◽  
Group A ◽  
Group B ◽  
Anti Hiv

Objectives: Self-administered vaginal rings are a promising method for delivery of topical anti-HIV microbicidesand might offer an adherence advantage over daily or coitally-dependent dosage forms such as gels. This trialassessed the safety and pharmacokinetic aspects of the Dapivirine Vaginal Ring-004 when worn as multiple rings oversequential periods of ring use by healthy, sexually-active, HIV-negative women.Methods: This double-blind trial was conducted among 48 women (18-40 years). Participants were randomlyassigned to two groups (A or B) and received (3:1) either the dapivirine or a placebo vaginal ring. Group A used tworings over a 56-day period and Group B used three rings over a 57-day period. Safety evaluations were conductedthroughout the trial. Dapivirine concentrations were measured in plasma, vaginal fluid and cervical tissue samplescollected during and after the 56 days (Group A) or 57 days (Group B) of vaginal ring use.Results: Ring-004 was safe and well tolerated in all participants. The pharmacokinetic profile demonstrated arapid increase in plasma and vaginal fluid concentrations and achieved concentrations in vaginal fluids and cervicaltissue well above the in vitro IC99 in cervical tissue (3.3 ng/mL) that were sustained for a 28 to 35-day ring use period(approximately 3000 times higher in vaginal fluids and 14 -1000 times higher in cervical tissue). Drug levels wereassociated with significant inhibitory activity of genital secretions against HIV ex vivo, a biomarker of pharmacodynamics.Individual plasma dapivirine concentrations did not exceed 553 pg/mL and were well below plasma concentrations atthe maximum tolerated dose for oral treatment (mean Cmax 2286 ng/mL).Conclusions: The consecutive use of several rings over a period of up to 57 days was safe and well tolerated, andPK data indicate that a single Ring-004 is likely to be protective for at least 35 days.

Comparison of the effects of Dexamethasone and Ondansetron on the Reduction of Postoperative Nausea and Vomiting following Cesarean Section under Spinal Anesthesia

2020 ◽  
Vol 15 ◽  
Author(s):  
Arash karimi ◽  
Jahanbakhsh Nejadi ◽  
Mahnaz Shamseh ◽  
Nooshin Ronasi ◽  
Mehdi Birjandi
Keyword(s):  
Cesarean Section ◽  
Spinal Anesthesia ◽  
Postoperative Nausea ◽  
Demographic Data ◽  
Postoperative Nausea And Vomiting ◽  
Nausea And Vomiting ◽  
Elective Cesarean Section ◽  
Double Blind ◽  
Group A ◽  
Group B

Background: Postoperative nausea and vomiting (PONV) is a common complication associated with the use of anesthesia. Several antiemetics are used to reduce the incidence and severity of PONV. The aim of this study is to investigate the role of dexamethasone and ondansetron to treat PONV in patients undergoing cesarean section (c-section) under spinal anesthesia. Methods: This double-blind clinical trial study was performed on patients who were referred to the operating room of Haji Karim Asali Hospital of Khorramabad for elective cesarean section in 2016-17. Upon meeting the inclusion criteria, patients were allotted into two groups (n=60). Group A received 8mg of dexamethasone and group B received 4mg of ondansetron after spinal anesthesia. The Visual Analog Scale (VAS) questionnaire and Depression-Anxiety-Stress Scale (DASS) questionnaire was used for the analysis. Patients with mild to moderate stress, anxiety, and depression were included in the study. Data were analyzed using SPSS 16 software. Results: There was no difference in the demographic data of the two groups. The mean severity of nausea in group A was significantly higher than in group B. The frequency of vomiting in group A was 20 times higher than group B, which was found to be statistically significant, p = 0.018. Concerning the type of delivery with the frequency of nausea, the results showed that the frequency of nausea in group A was 3.24 times higher than group B, however, this difference was not statistically significant, p = 0.106. Conclusion: Based on the results of this study, ondansetron had a significant effect on the alleviation of postoperative nausea and vomiting, as compared to dexamethasone in c-section surgical candidates.

scholarly journals Management of walled-off necrosis with nasocystic irrigation with hydrogen peroxide versus biflanged metal stent: randomized controlled trial

2021 ◽  
Vol 09 (07) ◽  
pp. E1108-E1115
Author(s):  
Sudhir Maharshi ◽  
Shyam Sunder Sharma ◽  
Sandeep Ratra ◽  
Bharat Sapra ◽  
Dhruv Sharma
Keyword(s):  
Hydrogen Peroxide ◽  
Adverse Events ◽  
Clinical Success ◽  
Controlled Trial ◽  
Procedure Time ◽  
Metal Stent ◽  
Technical Success ◽  
Group A ◽  
Group B ◽  
Walled Off Necrosis

Abstract Background and study aims Walled-off necrosis (WON) is a known complication of acute necrotizing pancreatitis (ANP). There is no study comparing nasocystic irrigation with hydrogen peroxide (H2O2) versus biflanged metal stent (BMS) in the management of WON. The aim of this study was to compare the clinical efficacy of both the treatment strategies. Patients and methods This study was conducted on patients with symptomatic WON who were randomized to nasocystic irrigation with H2O2 (Group A) and BMS placement (Group B). Primary outcomes were clinical and technical success while secondary outcomes were procedure time, adverse events, need for additional procedures, duration of hospitalization, and mortality. Results Fifty patients were randomized into two groups. Group A (n = 25, age 37.8 ± 17.6 years, 16 men) and Group B (n = 25, age 41.8 ± 15.2 years, 17 men). There were no significant differences in baseline characteristics between the two groups. The most common etiology of pancreatitis was alcohol, observed in 27 (54 %) patients. Technical success (100 % vs 96 %, P = 0.98), clinical success (84 % vs 76 %, P = 0.76), requirement of additional procedures (16 % vs 24 %, P = 0.70) and adverse events (4 vs 7, P = 0.06) were comparable in both the groups. The duration to clinical success (34.4 ± 12 vs 14.8 ± 10.8 days, P = 0.001) and procedure time (36 ± 15 vs 18 ± 12 minutes, P = 0.01) were longer in Group A compared to Group B. Conclusions Nasocystic irrigation with H2O2 and BMS are equally effective in the management of WON but time to clinical success and procedure time is longer with nasocystic irrigation.

scholarly journals Effectiveness and safety of secukinumab in 608 patients with psoriatic arthritis in real life: a 24-month prospective, multicentre study

RMD Open ◽  
2021 ◽  
Vol 7 (1) ◽  
pp. e001519
Author(s):  
Roberta Ramonda ◽  
Mariagrazia Lorenzin ◽  
Antonio Carriero ◽  
Maria Sole Chimenti ◽  
Raffaele Scarpa ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Adverse Events ◽  
Disease Activity ◽  
Biological Treatment ◽  
Retention Rate ◽  
Real Life ◽  
Drug Retention ◽  
Group A ◽  
Group B ◽  
Drug Retention Rate

ObjectivesTo evaluate in a multicentric Italian cohort of patients with psoriatic arthritis (PsA) on secukinumab followed for 24 months: (1) the long-term effectiveness and safety of secukinumab, (2) the drug retention rate and minimal disease activity (MDA), (3) differences in the outcomes according to the biological treatment line: biologic-naïve patients (group A) versus multifailure (group B) patients.MethodsConsecutive patients with PsA receiving secukinumab were evaluated prospectively. Disease characteristics, previous/ongoing treatments, comorbidities and follow-up duration were collected. Disease activity/functional/clinimetric scores and biochemical values were recorded at baseline (T0), 6(T6), 12(T12) and 24(T24) months. Effectiveness was evaluated overtime with descriptive statistics; multivariate Cox and logistic regression models were used to evaluate predictors of drug-discontinuation and MDA at T6. Infections and adverse events were recorded.Results608 patients (41.28% men; mean (SD) age 52.78 (11.33)) were enrolled; secukinumab was prescribed as first-line biological treatment in 227 (37.34%) patients, as second (or more)-line biological treatment in 381 (62.66%). Effectiveness of secukinumab was shown with an improvement in several outcomes, such as Ankylosing Spondylitis Disease Activity Score (T0=3.26 (0.88) vs T24=1.60 (0.69) ;p=0.02) and Disease Activity Index for Psoriatic Arthritis (T0=25.29 (11.14) vs T24=7.69 (4.51); p<0.01). At T24, group A showed lower Psoriasis Area Severity Index (p=0.04), erythrocyte sedimentation rate and C reactive protein (p=0.03 ;p=0.05) and joint count (p=0.03) compared with group B. At T24, MDA was achieved in 75.71% of group A and 70.37% of group B. Treatment was discontinued in 123 (20.23%) patients, mainly due to primary/secondary loss of effectiveness, and in 22 due to adverse events. Retention rate at T24 was 71% in the whole population, with some difference depending on secukinumab dosage (p=0.004) and gender (p=0.05).ConclusionsIn a real-life clinical setting, secukimumab proved safe and effective in all PsA domains, with notable drug retention rate.

scholarly journals Incidence of Bacteriuria after Urodynamic Study with or without Antibiotic Prophylaxis in Women with Urinary Incontinence

2017 ◽  
Vol 39 (10) ◽  
pp. 534-540 ◽  
Author(s):  
Elizabeth Hirakauva ◽  
Ana Bianchi-Ferraro ◽  
Eliana Zucchi ◽  
Marcio Kajikawa ◽  
Manoel Girão ◽  
...  
Keyword(s):  
Urinary Incontinence ◽  
Placebo Group ◽  
Urinary Tract ◽  
Antibiotic Prophylaxis ◽  
Urine Culture ◽  
Placebo Control ◽  
Urodynamic Study ◽  
Group A ◽  
Group B ◽  
Group D

Introduction The presence of bacteria in urine is called bacteriuria, which may be symptomatic or asymptomatic. The manipulation of the urinary tract during urodynamic study (UDS), which is an invasive procedure, can result in urinary tract infection (UTI). Studies on the use of prophylactic antibiotics for UDSs are contradictory. Some investigators concluded that they were valuable and others did not. The objective of this study is to evaluate the efficacy of antibiotic prophylaxis before UDS. This is a placebo-control randomized double-blind study. Methods Two-hundred and seventeen women affected by urinary incontinence were eligible for this study. All patients had presented negative urine culture previous to the UDS. They were randomized in four groups: group A received placebo, group B received 500 mg of levofloxacin, group C received 80 mg trimethoprim and 400 mg sulfamethoxazole and group D received 100 mg of nitrofurantoin. A urine culture was performed 14 days after the UDS. Results We observed asymptomatic bacteriuria after the UDS in five patients in group A, one in group B, one in group C and one in group D. Only one patient on group A had symptomatic bacteriuria. We didn't observe statistical difference between the groups. When we recategorized the patients in two groups, the incidence of bacteriuria was significantly higher in the placebo group compared with the antibiotic group. Conclusion The conclusion is that antibiotic prophylaxis before the UDS did not reduce the incidence of UTI in women within the target population.

The effect of external ventricular drain tunneling length on CSF infection rate in pediatric patients: a randomized, double-blind, 3-arm controlled trial

2021 ◽  
pp. 1-8
Author(s):  
Esmaeil Mohammadi ◽  
Sara Hanaei ◽  
Sina Azadnajafabad ◽  
Keyvan Tayebi Meybodi ◽  
Zohreh Habibi ◽  
...  
Keyword(s):  
Infection Rate ◽  
Pediatric Patients ◽  
Controlled Trial ◽  
External Ventricular Drain ◽  
Hazard Ratio ◽  
Spontaneous Discharge ◽  
Standard Group ◽  
Double Blind ◽  
Group A ◽  
Group B

OBJECTIVE The role of tunneling an external ventricular drain (EVD) more than the standard 5 cm for controlling device-related infections remains controversial. METHODS This is a randomized, double-blind, 3-arm controlled trial done in the Children’s Medical Center in Tehran, Iran. Pediatric patients (< 18 years old) with temporary hydrocephalus requiring an EVD and no evidence of CSF infection or prior EVD insertion were enrolled. Patients were randomly assigned (1:1:1) into the following arms: 5-cm (standard; group A); 10-cm (group B); or 15-cm (group C) EVD tunnel lengths. The investigators, parents, and person performing the analysis were masked. The surgeon was informed of the length of the EVD by the monitoring board just before operation. Patients were followed until the EVD’s fate was established. Infection rate and other complications related to EVDs were assessed. RESULTS A total of 105 patients were enrolled in three random groups (group A = 36, group B = 35, and group C = 34). The EVD was removed because there was no further need in most cases (67.6%), followed by conversion to a new EVD or ventriculoperitoneal shunt (15.2%), infection (11.4%), and spontaneous discharge without further CSF diversion requirement (5.7%). No statistical difference was found in infection rate (p = 0.47) or EVD duration (p = 0.81) between the three groups. No group reached the efficacy point sooner than the standard group (group B: hazard ratio 1.21, 95% CI 0.75–1.94, p = 0.429; group C: hazard ratio 1.03, 95% CI 0.64–1.65, p = 0.91). CONCLUSIONS EVD tunnel lengths of 5 cm and longer did not show a difference in the infection rate in pediatric patients. Indeed, tunneling lengths of 5 cm and greater seem to be equally effective in preventing EVD infection. Clinical trial registration no.: IRCT20160430027680N2 (IRCT.ir)

scholarly journals Prospective Parallel Randomized, Double-Blind, Double-Dummy Controlled Clinical Trial Comparing Clomiphene Citrate and Metformin as the First-Line Treatment for Ovulation Induction in Nonobese Anovulatory Women with Polycystic Ovary Syndrome

2005 ◽  
Vol 90 (7) ◽  
pp. 4068-4074 ◽  
Author(s):  
Stefano Palomba ◽  
Francesco Orio ◽  
Angela Falbo ◽  
Francesco Manguso ◽  
Tiziana Russo ◽  
...  
Keyword(s):  
Polycystic Ovary ◽  
Clomiphene Citrate ◽  
Controlled Clinical Trial ◽  
Line Treatment ◽  
First Line ◽  
Ovary Syndrome ◽  
Double Blind ◽  
Group A ◽  
Group B ◽  
First Line Treatment

Abstract Context: Although metformin has been shown to be effective in the treatment of anovulation in women with polycystic ovary syndrome (PCOS), clomiphene citrate (CC) is still considered to be the first-line drug to induce ovulation in these patients. Objective: The goal of this study was to compare the effectiveness of metformin and CC administration as a first-line treatment in anovulatory women with PCOS. Design: We describe a prospective parallel randomized, double-blind, double-dummy controlled clinical trial. Setting: The study was conducted at the University “Magna Graecia” of Catanzaro, Catanzaro, Italy. Patients: One hundred nonobese primary infertile anovulatory women with PCOS participated. Interventions: We administered metformin cloridrate (850 mg twice daily) plus placebo (group A) or placebo plus CC (150 mg for 5 d from the third day of a progesterone withdrawal bleeding) (group B) for 6 months each. Mean outcome measures: The main outcome measures were ovulation, pregnancy, abortion, and live-birth rates. Results: The subjects of groups A (n = 45) and B (n = 47) were studied for a total of 205 and 221 cycles, respectively. The ovulation rate was not statistically different between either treatment group (62.9 vs. 67.0%, P = 0.38), whereas the pregnancy rate was significantly higher in group A than group B (15.1 vs. 7.2%, P = 0.009). The difference found between groups A and B regarding the abortion rate was significant (9.7 vs. 37.5%, P = 0.045), whereas a positive trend was observed for the live-birth rate (83.9 vs. 56.3%, P = 0.07). The cumulative pregnancy rate was significantly higher in group A than group B (68.9 vs. 34.0%, P &lt; 0.001). Conclusions: Six-month metformin administration is significantly more effective than six-cycle CC treatment in improving fertility in anovulatory nonobese PCOS women.

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