scholarly journals A randomized double-blind controlled study on the efficacy and safety of Sangdantongluo granule in the treatment of post-stroke spasticity

2021 ◽  
Author(s):  
le xie ◽  
Yao Xie ◽  
Guo Mao ◽  
Junlin Jiang ◽  
Ting Yao ◽  
...  
Keyword(s):  
Secondary Outcome ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Post Stroke ◽  
Modified Ashworth Scale ◽  
The Common ◽  
To Receive ◽  
Primary Measure ◽  
Ashworth Scale

Abstract BackgroundStroke is the first leading cause of mortality and disability worldwide, and post-stroke spasticity (PSS) is the common complication of stroke. Sangdantongluo Granule, a modern patent Traditional Chinese medicine (TCM), is widely used in clinical practice to treat PSS. Whereas, there is limited evidence of effectiveness for Sangdantongluo Granule to treat PSS. This study will evaluate the clinical efficacy and safety of Sangdantongluo granule in the treatment of PSS. MethodsThis multicenter, randomized, double-blind and placebo-controlled study will recruit 132 participants in China who develops PSS 15 days to 90 days after stroke. Participants will be randomly assigned in an equal ratio to receive either Sangdantongluo granule or placebo for 2 months twice a day orally. The primary measure is the Modified Ashworth Scale (MAS), Secondary outcome measures include Compopsite Spasticity Scale (CSS), Simplified Fugl-Meyer Motor Scale (S-FM), National Institute of Health stroke scale (NIHSS), Modified Rankin Scale (mRS), Modified Barther Index (MBI), and Surface electromyography. Adverse events will be supervised throughout the trial. DiscussionThe results of this study will present whether Sangdantongluo granule is clinical effective and safe for managing PSS.Trial registrationClinicalTrials.gov ChiCTR2100044544. Registered on 23 March 2021.

scholarly journals Efficacy and safety of galcanezumab for prevention of migraine headache in Japanese patients with episodic migraine: A phase 2 randomized controlled clinical trial

2020 ◽  
Vol 3 ◽  
pp. 251581632093257 ◽  
Author(s):  
Fumihiko Sakai ◽  
Akichika Ozeki ◽  
Vladimir Skljarevski
Keyword(s):  
Migraine Headache ◽  
Japanese Patients ◽  
Episodic Migraine ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Controlled Clinical Trial ◽  
Life Questionnaire ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Secondary Endpoints

Objective: This study was designed to assess the efficacy and safety of galcanezumab in comparison with placebo for the prevention of migraine in Japanese patients with episodic migraine. Methods: In this double-blind, placebo-controlled study, which was conducted over 6 months, randomized adult patients received subcutaneous injections of galcanezumab (120 mg n = 115, 240 mg n = 114) or placebo ( n = 230) once monthly. The primary endpoint was the overall mean change from baseline in the number of monthly migraine headache days. The key secondary outcome measures were response rates (≥50%, ≥75%, and 100%); the Migraine-Specific Quality-of-Life Questionnaire Role Function-Restrictive score; monthly migraine headache days requiring acute treatment; and Patient Global Impression of Severity (PGI-S). Results: The mean change from baseline in monthly migraine headache days over months 1–6 was significantly ( p < 0.001) greater for the 120-mg galcanezumab dose (−3.60 days) and the 240-mg galcanezumab dose (−3.36 days) compared with placebo (−0.59 days). Both the 120-mg and 240-mg doses of galcanezumab were superior compared with placebo for each of the key secondary endpoints except for PGI-S (only the 240-mg dose was superior). The most commonly reported treatment-emergent adverse events were local injection-site reactions; erythema, swelling, pruritus, and pain were more commonly reported by patients who were treated with galcanezumab than those treated with placebo. Conclusion: The number of monthly migraine headache days was reduced with both doses of galcanezumab, and both doses were safe and well tolerated in Japanese patients with episodic migraine.

scholarly journals Efficacy and Safety of Tradipitant in Diabetic and Idiopathic Gastroparesis: A Randomized, Placebo-Controlled Study

2020 ◽  
Author(s):  
Jesse L. Carlin ◽  
V. Rose Lieberman ◽  
Arya Dahal ◽  
Madison S. Keefe ◽  
Changfu Xiao ◽  
...  
Keyword(s):  
Unmet Need ◽  
Nausea And Vomiting ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Symptom Index ◽  
Idiopathic Gastroparesis ◽  
Patient Reported ◽  
Cardinal Symptom ◽  
To Receive

AbstractBackground and AimsThere is a high unmet need for the treatment of gastroparesis and studies of NK1-R antagonists suggest potential benefit in reducing the symptoms of nausea and vomiting. We hypothesized that tradipitant, an NK1-R antagonist, would be effective in treating patients with idiopathic or diabetic gastroparesis.MethodsIn a randomized, double-blind, placebo-controlled study across 47 U.S. sites, 152 gastroparesis patients were randomized to receive oral 85mg BID tradipitant (n=77) or placebo (n=75) daily for four weeks. Symptoms were assessed using a daily symptom dairy, Gastroparesis Cardinal Symptom Index (GCSI), and other patient reported questionnaires.ResultsPatients receiving tradipitant had a significant decrease in nausea score at Week 4 compared to placebo (−1.2 improvement vs −0.7, respectively, p=0.0099), and a significant increase in nausea-free days (28.8% increase on tradipitant vs 15.0% on placebo p=0.0160). Patients with both nausea and vomiting at baseline (n=101) showed an even greater decrease in nausea score (−1.4 improvement on tradipitant vs −0.4 on placebo p<0.0001) and an increase in nausea free days (32.3% improvement on tradipitant vs 7.6% on placebo p=0.0003). 32.9% of patients treated with tradipitant were nausea responders (average nausea score ≤ 1 at week 4) compared to 11.8% of patients on placebo (p=0.0013). 46.6% of patients treated with tradipitant had a greater than 1-point improvement in GCSI score compared to 23.5% of patients on placebo (p=0.0053).ConclusionsTradipitant treatment resulted in statistically and clinically meaningful improvements in nausea and overall gastroparesis symptoms. These robust efficacy results suggest tradipitant has the potential to become a useful pharmacological treatment for gastroparesis.

scholarly journals Efficacy and Safety of Cordyceps militaris as an Adjuvant to Duloxetine in the Treatment of Insomnia in Patients With Depression: A 6-Week Double- Blind, Randomized, Placebo-Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Jiaojiao Zhou ◽  
Xu Chen ◽  
Le Xiao ◽  
Jingjing Zhou ◽  
Lei Feng ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Depression Scale ◽  
Cordyceps Militaris ◽  
Secondary Outcome ◽  
Controlled Study ◽  
Depression Symptom ◽  
Hamilton Depression Scale ◽  
Efficacy And Safety ◽  
Double Blind

Background: Insomnia is a common clinical manifestation in patients with depression. Insomnia is not only a depression symptom but also an independent risk factor for recurrence. Cordyceps militaris (C. militaris) is thought to have the potential to treat insomnia. This study aimed to examine the efficacy and safety of duloxetine with C. militaris in improving sleep symptoms in patients with depression.Methods: This study was a single-center, randomized, double-blind, placebo-controlled study that recruited outpatients admitted to Beijing Anding hospital from January 2018 to January 2019. Major depressive disorder (MDD) with insomnia was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and Mini-International Neuropsychiatric Interview (M.I.N.I.). Eligible subjects will be randomly assigned to two treatment groups in a 1:1 ratio, and receive treatment and follow-up of about 6 weeks of duloxetine plus Cordyceps militaris or placebo, respectively. The severity of depression and insomnia was evaluated at baseline and at 1, 2, 4, and 6 weeks using the 17-item Hamilton Depression Scale (HAMD-17) and Athens Insomnia Scale (AIS).Results: A total of 59 subjects were included in the study (31 in the placebo group and 28 in the C. militaris group). 11 (18.6%) participants withdrew during the study period, 5 (17.9%) in the C. militaris group, and 6 (19.3%) in the placebo group. Depressive and sleep symptoms in all patients reduced over time. We found that the total scores of AIS and its subscales decreased more in the placebo group compared to the C. militaris group (p &lt; 0.05). Secondary outcome revealed that there were no significant differences between the two groups in total HAMD-17 and its sleep factor scores (p &gt; 0.05) at 1, 2, 4, and 6 weeks after treatment initiation. The incidences of adverse events were not significantly different between the two groups (all p &gt; 0.05).Conclusion:C. militaris at the current dose and duration did not improve sleep symptoms in patients with depression, but it is safe with rare side effects.

scholarly journals Prevention of Relapse in Reflux Esophagitis: A Placebo Controlled Study of Ranitidine 150 mg BID and 300 mg BID

1997 ◽  
Vol 11 (1) ◽  
pp. 83-88 ◽  
Author(s):  
John H Hegarty ◽  
Lars Halvorsen ◽  
Bouke P Hazenberg ◽  
Andrzej Nowak ◽  
Colin L Smith ◽  
...  
Keyword(s):  
Reflux Esophagitis ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Parallel Group ◽  
Symptomatic Relapse ◽  
To Receive ◽  
Prevention Of Relapse ◽  
Relapse Rates

OBJECTIVE:To compare the efficacy and safety of long term use of ranitidine 150 mg bid, 300 mg bid and placebo in prevention of endoscopic and symptomatic relapse of reflux esophagitis in an international, double-blind, placebo controlled, parallel group study.PATIENTS AND METHODS:A total of 279 patients at least 18 years old from hospital out-patient departments with healed esophagitis (grade 0) with no or mild symptoms entered the study. Patients were randomly allocated to receive ranitidine 150 mg, 300 mg or placebo twice daily for 48 weeks. Patients returned for symptom assessments at eight-week intervals and for re-endoscopy every 16 weeks.RESULTS:Both ranitidine regimens were significantly more effective than placebo in preventing endoscopic and symptomatic relapse of reflux esophagitis (P=0.003 for ranitidine 150 mg bid; P<0.001 for ranitidine 300 mg bid). No statistically significant differences were observed in relapse rates between the two ranitidine regimens. The percentage of patients with endoscopic relapse (grade 2) after 48 weeks were 60%, 37% and 27% for placebo, ranitidine 150 mg bid and ranitidine 300 mg bid, respectively (P=0.002 for ranitidine 150 mg bid versus placebo; P<0.001 for ranitidine 300 mg bid versus placebo). Ranitidine was well tolerated.CONCLUSIONS:Ranitidine 150 mg bid and 300 mg bid are safe and effective treatments in the prevention of reflux esophagitis relapse.

Sign in / Sign up

Export Citation Format

Share Document