scholarly journals Efficacy and safety of topical diclofenac/menthol gel for ankle sprain: A randomized, double-blind, placebo- and active-controlled trial

2017 ◽  
Vol 45 (2) ◽  
pp. 647-661 ◽  
Author(s):  
Pamela M. Lai ◽  
Agron Collaku ◽  
Kenneth Reed
Keyword(s):  
Ankle Sprain ◽  
Controlled Trial ◽  
Area Under The Curve ◽  
Complete Recovery ◽  
Response To Treatment ◽  
Secondary Outcome ◽  
Application Site ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Adolescents And Adults

Purpose This study was performed to evaluate topical 1% diclofenac/3% menthol gel in treating ankle sprain. Design In this randomized, double-blind, placebo-controlled trial, adolescents and adults with acute ankle sprain (N = 385) applied 4 g of gel containing 1% diclofenac/3% menthol (n = 117), 1% diclofenac (n = 112), 3% menthol (n = 77), or placebo (n = 75) four times daily. The primary outcome was the area under the curve of pain intensity (PI) on movement [0 (no pain) to 10 (extreme pain)] from 24 to 72 hours post-application (AUC1–3 days). Secondary outcomes included pain relief (PR); PI; time to onset of PR, meaningful PR, cooling, and complete recovery; PI difference; sum of PI difference; total PR; reduction in ankle swelling; and the patient’s global assessment of response to treatment. Results There were no statistically significant differences in AUC1–3 between 1% diclofenac/3% menthol and placebo, diclofenac, or menthol gels and no meaningful advantages of 1% diclofenac/3% menthol for any secondary outcome. There was a higher incidence of skin and application-site events with 1% diclofenac/3% menthol than with placebo or 1% diclofenac. Conclusion No significant improvement was observed with topical 1% diclofenac/3% menthol gel compared with placebo, 1% diclofenac, or 3% menthol gel in treating pain from ankle sprain. ClinicalTrials.Gov Identifier: NCT02100670

scholarly journals Methotrimeprazine versus haloperidol in palliative care patients with cancer-related nausea: a randomised, double-blind controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e029942 ◽  
Author(s):  
Janet Rea Hardy ◽  
Helen Skerman ◽  
Jennifer Philip ◽  
Phillip Good ◽  
David C Currow ◽  
...  
Keyword(s):  
Palliative Care ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Response Rates ◽  
Complete Response ◽  
Response To Treatment ◽  
Secondary Outcome ◽  
Double Blind ◽  
Intention To Treat ◽  
Point Reduction

ObjectivesMethotrimeprazine is commonly used for the management of nausea but never tested formally against other drugs used in this setting. The aim was to demonstrate superior antiemetic efficacy.DesignDouble-blind, randomised, controlled trial of methotrimeprazine versus haloperidol.Setting11 palliative care sites in Australia.ParticipantsParticipants were >18 years, had cancer, an average nausea score of ≥3/10 and able to tolerate oral medications. Ineligible patients had acute nausea related to treatment, nausea for which a specific antiemetic was indicated, were about to undergo a procedure or had received either of the study drugs or a change in glucocorticoid dose within the previous 48 hours.InterventionsBased on previous studies, haloperidol was used as the control. Participants were randomised to encapsulated methotrimeprazine 6·25 mg or haloperidol 1·5 mg one time or two times per day and assessed every 24 hours for 72 hours.Main outcome measuresA ≥two-point reduction in nausea score at 72 hours from baseline. Secondary outcome measures were as follows: complete response at 72 hours (end nausea score less than 3), response at 24 and 48 hours, vomiting episodes, use of rescue antiemetics, harms and global impression of change.ResultsResponse to treatment at 72 hours was 75% (44/59) in the haloperidol (H) arm and 63% (36/57) in the methotrimeprazine (M) arm with no difference between groups (intention-to-treat analysis). Complete response rates were 56% (H) and 51% (M). In theper protocolanalysis, there was no difference in response rates: (85% (44/52) (H) and 74% (36/49) (M). Completeper protocolresponse rates were 64% (H) and 59% (M). Toxicity worse than baseline was minimal with a trend towards greater sedation in the methotrimeprazine arm.ConclusionThis study did not demonstrate any difference in response rate between methotrimeprazine and haloperidol in the control of nausea.Trial registration numberACTRN 12615000177550.

scholarly journals Jiao-tai-wan for insomnia symptoms caused by the disharmony of the heart and kidney: a study protocol for a randomized, double-blind, placebo-controlled trial

2020 ◽  
Author(s):  
Congcong Zeng ◽  
Xi Liu ◽  
Lufeng Hu ◽  
Yuan Feng ◽  
Nengzhi Xia ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Outcome Measures ◽  
Study Protocol ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Resonance Spectroscopy ◽  
Double Blind ◽  
Drug Intervention ◽  
Double Blind Placebo ◽  
Insomnia Symptoms

Abstract Background: Insomnia seriously affects people’s normal lives and work. However, effective treatment strategies are scarce. The purpose of this study is to explore the efficacy and safety of Jiao-tai-wan (JTW) for ameliorating insomnia symptoms caused by disharmony of the heart and kidney. Design: This is a randomized, double-blind, placebo-controlled pilot clinical trial. One hundred twenty-four participants suffering from insomnia symptoms will randomly assigned to the JTW or placebo group in an equal ratio. The participants will be asked to take JTW or placebo granules twice a day for 1 week. All data will be gathered at baseline and at the end of drug intervention. The primary outcome measures will be the mean change in the Pittsburgh sleep quality index (PSQI) from baseline to the end of drug intervention. Secondary outcome measures will include the the altered sleep parameters in polysomnography, 1H-magnetic resonance spectroscopy (1H-MRS) evalution, the Disharmony of Heart and Kidney Scoring System score and blood tests, including the levels of serum adenosine and melatonin. A laboratory test will be taken before and after treatment to assess the safety of JTW. Discussion: The outcomes of this study will confirm the efficacy of JTW for the treatment of insomnia symptoms, and will also be used to monitor the safety of JTW. Trial registration: Chinese Clinical Trial Registry, ChiCTR1800019239.Registered on 1st November 2018- Retrospectively registered, http://www.chictr.org.cn/. Keywords: Jiao-tai-wan, Insomnia, Traditional herbal medicine, Randomized controlled trial, Study protocol, Pattern identification Protocol version: Manuscript based on study protocol version 1.3, 1 November 2018.

scholarly journals Primary Prophylaxis to Prevent Tuberculosis Infection in Prison Inmates:A Randomized, Double-Blind, Placebo-Controlled Trial

2019 ◽  
Author(s):  
Roberto Dias de Oliveira ◽  
Andrea da Silva Santos ◽  
Cassia Barbosa Reis ◽  
Alessandra de Cássia Leite ◽  
Flávia Patussi Correia Sacchi ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Primary Prophylaxis ◽  
Tuberculosis Infection ◽  
Secondary Outcome ◽  
Double Blind ◽  
Middle Income ◽  
High Exposure ◽  
Double Blind Placebo ◽  
Clinical Benefits

Abstract Background. In many low- and middle-income countries, tuberculosis incidence in prisons is high, exposing incarcerated populations to an elevated risk of tuberculosis infection. Methods. We conducted a randomized, double-blind, placebo-controlled trial among HIV-negative male inmates of a high tuberculosis burden prison to determine whether twice-weekly isoniazid (900 mg) for 12 months prevents tuberculosis infection. The primary outcome was QuantiFERON–TB Gold Plus (QFT) conversion to ≥0.35 IU/ml at 6 months; the secondary outcome was conversion at any time point. Alternative QFT positivity thresholds (≥0.7, ≥2.0, and ≥4.0 IU/ml) were investigated as exploratory endpoints. Results. In total, 467 participants were randomly assigned to isoniazid (N=258) or placebo (N=209). In an interim analysis of participants who had completed six months of follow-up (N=171), QFT conversion occurred in 20.7% (19/92) and 21.5% (17/79) of participants in isoniazid and placebo arms (efficacy: 4.0%; P=0.88). The trial was then stopped for futility, and the remaining participants underwent QFT testing. Among all participants with a second QFT test at 6-months, conversion occurred in 19.7% (26/132) and 30.3% (37/122) of participants in isoniazid and placebo arms (efficacy: 35.1%; P=0.04). Protection was also seen among all individuals with a follow-up QFT (5/132 [3.8%] vs 14/122 [11.5%]; efficacy: 67.0%, P=0.01). In exploratory analyses, the isoniazid arm had significantly lower rates of conversion at ≥2.0 IU/ml (67.0% efficacy, P=0.01), but not at other cutoff values. Discontinuations and losses to follow-up were high in both arms (isoniazid, 126/258 [48.8%]; placebo, 87/209 [41.6%]; P=0.14), due to elective withdrawal (24.0% vs 21.5%; P=0.60) and transfer or release from prison (19.0% vs 18.2%; P=0.92). Conclusions. Our results suggest that 900 milligrams of isoniazid given twice weekly may confer partial protection against QFT conversion in high exposure environments; however, discontinuation rates in both arms were high, which would limit the clinical benefits of this prevention method.

Abstract 12868: Morphine Decreases Ticagrelor Concentrations but Not Its Effects: A Randomized, Double-Blind, Placebo-Controlled Trial

Circulation ◽  
2015 ◽  
Vol 132 (suppl_3) ◽  
Author(s):  
Eva-Luise Hobl ◽  
Birgit Reiter ◽  
Thomas Stimpfl ◽  
Christian Schoergenhofer ◽  
Michael Schwameis ◽  
...  
Keyword(s):  
Drug Interactions ◽  
Active Metabolite ◽  
Drug Exposure ◽  
Controlled Trial ◽  
Plasma Concentrations ◽  
Area Under The Curve ◽  
Blood Platelet ◽  
Loading Dose ◽  
Double Blind ◽  
Double Blind Placebo

Introduction: Our recent drug interaction trial with clopidogrel showed that morphine decreases the concentrations and effects of clopidogrel, which could lead to treatment failure in susceptible individuals. This study examined possible drug-drug interactions between ticagrelor and morphine. Hypothesis: We hypothesized that the pharmacodynamic consequences of drug-drug interactions would be less between morphine and ticagrelor. Methods: Twenty-four healthy subjects received a loading dose of 180mg ticagrelor together with placebo or 5mg morphine intravenously in a randomized, double-blind, placebo-controlled, cross-over trial. Pharmacokinetics were determined by liquid chromatography tandem mass spectrometry, and ticagrelor effects were measured by platelet function tests. Results: Concomitant i.v. injection of morphine slows drug resorption of ticagrelor and its active metabolite (p<0.05) by one hour and decreases plasma levels of ticagrelor and its active metabolite (by 25-31%; p < 0.03) and the drug exposure (area under the curve by 22-23%; p < 0.01). Importantly, however, the effects of ticagrelor on platelet aggregation in whole blood, platelet plug formation, and vasodilator-stimulated phosphoprotein (VASP) phosphorylation are not affected by morphine. Conclusions: Morphine co-administration moderately decreases ticagrelor plasma concentrations but does not inhibit ist effects. Therefore, a 180 mg loading dose of ticagrelor appears to provide consistent and reliable platelet inhibition when morphine has to be given for pain relief.

scholarly journals Press needle for the Prevention of Aspiration Pneumonia in Elderly People: Study Protocol for a Randomized Double-Blind Placebo-Controlled trial.

2021 ◽  
Author(s):  
Soichiro Kaneko ◽  
Akiko Kikuchi ◽  
Shin Takayama ◽  
Ryutaro Arita ◽  
Yumika Seki ◽  
...  
Keyword(s):  
Elderly People ◽  
Aspiration Pneumonia ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Lower Limbs ◽  
Secondary Outcome ◽  
Swallowing Function ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Investigation Period

Abstract Background: Pneumonia is the fifth most common cause of death among the Japanese, with 97% of deaths occurring among elderly people aged 65 years or older. The incidence ratio of aspiration pneumonia is high for elderly people. Therefore, prophylaxis is important in geriatric medicine. In our previous studies, we reported that stimulation to the acupoints at ST36 and KI3 of the lower limbs with press needle improved the swallowing function of patients with dysphagia. The improvement of swallowing function may prevent aspiration pneumonia. The aim of this study is to investigate the protective efficacy of using press needle stimulation in the lower limbs for aspiration pneumonia.Methods/design: This is a multi-center, randomized double-blind placebo-controlled trial. A total of 140 patients with cerebrovascular disorder with a history of aspiration pneumonia will be recruited from six centers and randomly assigned to either the real press needle group or the sham press needle group in a 1:1 ratio. The press needle will be replaced twice a week. Treatment will be administered bilaterally at acupoints ST36 and KI3. The primary outcome is the frequency of onset of aspiration pneumonia. The secondary outcome is improvement of the latent time of swallowing reflex (LTSR). The investigation period is of 12-month. The primary outcome will be evaluated throughout the period, and secondary outcomes will be assessed at baseline, 1st month, 6th month, and at the end of the investigation period.Discussion: This study will evaluate the effects of press needle on prevention of aspiration pneumonia and improvement of swallowing function of patients. The results of this study will help support the prophylaxis of aspiration pneumonia.Trial registration: UMIN000023123, registered on July 12th, 2016; https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000026460

scholarly journals A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Huang Qi Gui Zhi Wu Wu Tang granules in patients with rheumatoid arthritis

2018 ◽  
Author(s):  
Yang Liu ◽  
Yi-Ru Wang ◽  
Zhi-jie Xi ◽  
Yang Yu ◽  
Li Liu ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Decision Making ◽  
Controlled Trial ◽  
Rate Of Change ◽  
Secondary Outcome ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Multicenter Randomized Controlled Trial

Abstract Background: Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by swelling, pain, and synovial damage. Effective methods lack in the treatment of RA. A traditional prescription in use for thousands of years in China, Huang Qi Gui Zhi Wu Wu Tang (HQGZWWT) granule is still chosen to relive pain and prevent joint malformation in RA patients. However, no evidence-based medical research has been organized to assess the effectiveness and safety of HQGZWWT granules for RA. Methods/design: We will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to determine whether HQGZWWT granules can relieve pain and protect joints. We will randomly divide 120 patients with active arthritis for 3 months. Main measurements include ratio of 50 of ACR (American College of Rheumatology), change of DAS (28) from baseline to 3 months, and SHARP scores of van der Heijde from baseline to 12 months. SecondarymeasurementsincludeACR20, ACR70, Health Assessment Questionnaire-Disability Index (HAQ-DI), arthritis pain score, and Patient Global Assessment of Arthritis. The time points are set as baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months. In addition, the rate of change (score) in the ACR50 and DAS28 from the baseline to 2-week, 1-month, 2-month, 6-month, and 12-month follow-up are also the secondary outcome measures. Discussion: The findings of this research will elucidate the efficacy and safety of HQGZWWT granules and provide an alternative treatment for RA. In addition, our data will benefit the clinical decision-making on active RA and possibly be incorporated into future guidelines. Trial registration: ClinicalTrials.gov ID: NCT03593837. Keywords: Traditional Chinese medicine, Huang Qi Gui Zhi wu wu granules, placebo, active rheumatoid arthritis, multicenter, randomized controlled trial.

scholarly journals Treatment of acute bronchitis in adults with extract of Pelargonium Sidoides: a randomised, double-blind, placebo controlled trial

2007 ◽  
pp. 49-55
Author(s):  
A. G. Chuchalin ◽  
B. Berman ◽  
V. Lemakher
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Controlled Trial ◽  
Alternative Therapy ◽  
Acute Bronchitis ◽  
Complete Recovery ◽  
Primary Outcome Measure ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Pelargonium Sidoides

Acute bronchitis is a wide-spread disease. Although it is generally caused by viruses, antibiotics are used for its treatment too much often. So it is very important to evaluate alternative therapy of acute bronchitis. The aim of the trial was to assess efficacy and safety of Pelargonium Sidoides (EPs 7630 is a registered trademark of Dr. Willmar Schwabe GmbH & Co, Karlsruhe, Germany) compared to placebo in patients with acute bronchitis. Study design: randomised, double-blind, placebo controlled trial with planned interim analysis. The trial centres: 6 outpatient medical centres. Patients: 124 adult patients with acute bronchitis, onset of the disease ≤ 48 h, and severity of symptoms ≥ 5 according to BSS scale gave written informed concert. EPs 7630 or placebo were administered in the dose of 30 drops t.i.d. during 7 days. The primary outcome measure was BSS scoring at the 7th day of the treatment. BSS scoring decreased by 7.2 ± 3.1 in the EPs 7630 group (n = 64) vs 4.9 ± 2.7 in the placebo group (n = 60). 95 % confidence interval (CI, 1.21, 3.56) for difference of the effects between two groups demonstrated significant improvement in the EPs 7630 in 7 days of the treatment compared to the placebo group (p < 0.0001). The EPs 7630 patients had parameters of complete recovery for every of 5 individual symptoms reliably higher compared to placebo patients. During the first 4 days of the treatment therapeutic effect was noted in 68.8 % of the EPs 7630 group vs 33.3 % of the placebo group (p < 0.0001). Health-related quality of life improved better in the EPs 7630 patients compared to the placebo group. Adverse events were found in 25 of 124 patients: 15 / 64 in the EPs 7630 group and 10 / 60 in the placebo group. All the adverse events were considered as non-serious. The efficacy of EPs 7630 in treatment of adults with acute bronchitis was higher compared to placebo. It could be an efficient alternative drug in therapy of acute bronchitis at the absence of indications for antibiotics administration.

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