scholarly journals Efficacy and safety of cumaru syrup as complementary therapy in mild persistent asthma: a double-blind, randomized, placebo-controlled study

2012 ◽  
Vol 48 (4) ◽  
pp. 629-637
Author(s):  
Elisete Mendes Carvalho ◽  
Gilmara Holanda da Cunha ◽  
Francisco Vagnaldo Fechine ◽  
Célia Regina Amaral Uchôa ◽  
Manoel Odorico de Moraes Filho ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Persistent Asthma ◽  
Complementary Therapy ◽  
Post Treatment ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Pre Treatment ◽  
Mild Persistent Asthma

Amburana cearensis is a medicinal plant known as "cumaru". It is used in Northeast Brazil in the treatment of respiratory diseases. This was a randomized, double-blind, placebo-controlled study, with the aim of evaluating the efficacy and safety of cumaru syrup as complementary therapy in mild persistent asthma. The study consisted of 3 phases, pre-treatment, treatment and post-treatment. The primary efficacy outcome was comparison of the changes reported by patients of the cumaru and placebo groups after treatment, using the "Asthma Quality of Life Questionnaire" (AQLQ). The secondary outcome was the effect of cumaru syrup on lung function based on spirometry. The results showed that in the cumaru group, the proportion of patients who had global improvement in asthma symptoms was significantly greater (61.90%, P=0.0009) than in the placebo group (9.52%). Only the spirometric parameters Forced Vital Capacity (FVC) and Forced Expiratory Volume in 1 second (FEV1) showed significant intergroup differences in post-treatment (P<0.05). The hematological and serum chemistry tests performed in the pre-treatment and post-treatment showed no statistically significant differences (P>0.05). Adverse events were reported by 3 patients (14.29%) in the cumaru group and 3 patients (14.29%) in the placebo group. All adverse events were considered non-serious and mild.

scholarly journals Rice Bran Supplement Containing A Functional Substance, the Novel Peptide Leu-Arg-Ala, has Anti-Hypertensive Effects: A Double-Blind, Randomized, Placebo-Controlled Study

Nutrients ◽  
2019 ◽  
Vol 11 (4) ◽  
pp. 726
Author(s):  
Ogawa ◽  
Shobako ◽  
Fukuhara ◽  
Satoh ◽  
Kobayashi ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Placebo Group ◽  
Adverse Events ◽  
Rice Bran ◽  
Test Group ◽  
Normal Blood ◽  
Controlled Study ◽  
The Novel ◽  
Normal Blood Pressure ◽  
Double Blind

The anti-hypertensive effect of processed rice bran (PRB) was recently reported, for which the novel peptide Leu-Arg-Ala (LRA) was identified as the functional substance. The purpose of this study was to assess the anti-hypertensive effects of a rice bran supplement containing PRB in individuals with high-normal blood pressure (systolic blood pressure (SBP): 130–139 mmHg and/or diastolic blood pressure (DBP): 85–89 mmHg) or grade 1 hypertension (SBP: 140–159 mmHg and/or DBP: 90–99 mmHg). One hundred individuals with high-normal blood pressure or grade 1 hypertension were recruited to participate in this double-blind, randomized, placebo-controlled study. Participants were randomly allocated to the placebo group (n = 50) or the test group (n = 50). Each group took four test tablets (43 μg LRA/day) or four placebo tablets daily. The decrease in blood pressure in the test group compared with the placebo group was the primary outcome. Adverse events were recorded and hematological/urinary parameters measured to determine the safety of the supplement, which was the secondary outcome. In total, 87 participants completed the study. The SBP of the test group at 12 weeks was significantly lower than that of the placebo group (p = 0.0497). No serious adverse events were observed. Daily consumption of a rice bran supplement containing PRB can safely improve mildly elevated blood pressure.

scholarly journals A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial for Evaluation of the Efficacy and Safety of DKB114 on Reduction of Uric Acid in Serum

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3794
Author(s):  
Yu Hwa Park ◽  
Do Hoon Kim ◽  
Jung Suk Lee ◽  
Hyun Il Jeong ◽  
Kye Wan Lee ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Uric Acid ◽  
Placebo Group ◽  
Serum Uric Acid ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Food Ingredient ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Difference

This study sought to investigate the antihyperuricemia efficacy and safety of DKB114 (a mixture of Chrysanthemum indicum Linn flower extract and Cinnamomum cassia extract) to evaluate its potential as a dietary supplement ingredient. This clinical trial was a randomized, 12-week, double-blind, placebo-controlled study. A total of 80 subjects (40 subjects with an intake of DKB114 and 40 subjects with that of placebo) who had asymptomatic hyperuricemia (7.0–9.0 mg/dL with serum uric acid) was randomly assigned. No significant difference between the DKB114 and placebo groups was observed in the amount of uric acid in serum after six weeks of intake. However, after 12 weeks of intake, the uric acid level in serum of subjects in the DKB114 group decreased by 0.58 ± 0.86 mg/dL and was 7.37 ± 0.92 mg/dL, whereas that in the placebo group decreased by 0.02 ± 0.93 mg/dL and was 7.67 ± 0.89 mg/dL, a significant difference (p = 0.0229). In the analysis of C-reactive protein (CRP) change, after 12 weeks of administration, the DKB114 group showed an increase of 0.05 ± 0.27 mg/dL (p = 0.3187), while the placebo group showed an increase of 0.10 ± 0.21 mg/dL (p = 0.0324), a statistically significant difference (p = 0.0443). In the analysis of amount of change in apoprotein B, after 12 weeks of administration, the DKB114 group decreased by 4.75 ± 16.69 mg/dL (p = 0.1175), and the placebo group increased by 3.13 ± 12.64 mg/dL (p = 0.2187), a statistically significant difference between the administration groups (p = 0.0189). In the clinical pathology test, vital signs and weight measurement, and electrocardiogram test conducted for safety evaluation, no clinically significant difference was found between the ingestion groups, confirming the safety of DKB114. Therefore, it may have potential as a treatment for hyperuricemia and gout. We suggest that DKB114 as a beneficial and safe food ingredient for individuals with high serum uric acid. Trial registration (CRIS.NIH. go. Kr): KCT0002840.

scholarly journals 167 Randomized, Double-Blind, Active-Controlled Study of Starting Aripiprazole Lauroxil with 1-Day Initiation in Acutely Ill Patients with Schizophrenia

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 306-307
Author(s):  
Peter J. Weiden ◽  
Amy Claxton ◽  
Yangchun Du ◽  
Sergey Yagoda ◽  
David Walling ◽  
...  
Keyword(s):  
Adverse Events ◽  
Outpatient Setting ◽  
Controlled Study ◽  
Injection Site Pain ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Secondary Analyses ◽  
Site Pain ◽  
Over Time ◽  
Funding Acknowledgements

Abstract:Objective:Evaluate efficacy and safety of a 2-month dose of aripiprazole lauroxil (AL) with a 1-day initiation regimen during hospitalization for an acute exacerbation of schizophrenia.Methods:In the phase 3b double-blind ALPINE study, adults with schizophrenia were randomized to AL (AL NanoCrystal® Dispersion + oral aripiprazole 30 mg day 1; AL 1064 mg day 8 and every 8 weeks) or paliperidone palmitate (PP 234 mg day 1; PP 156 mg day 8 and every 4 weeks). Patients were discharged after 2 weeks of hospitalization and followed through week 25. Primary endpoint was within-group changes in PANSS total score from baseline to week 4 (observed cases). Secondary analyses included within-group changes at weeks 9 and 25 (observed) and between-group comparisons at weeks 4, 9, and 25 (MMRM). Adverse events (AEs) were monitored throughout the study.Results:200 patients were randomized (AL, n=99; PP, n=101); 56.6% and 42.6%, respectively, completed the study. Within-group changes from baseline in PANSS were −17.4 for AL and −20.1 for PP at week 4 (both groups, P<0.001) and continued to decline at weeks 9 (AL, −19.8; PP, −22.5) and 25 (AL, −23.3; PP, −21.7). The change in PANSS over time was similar between groups. AEs occurring in ≥10% of patients in either group were injection site pain (AL, 17.2%; PP, 24.8%), akathisia (AL, 9.1%; PP, 10.9%), and weight increased (AL, 9.1%; PP, 16.8%).Conclusions:AL and PP were effective and well-tolerated for initiating treatment of schizophrenia in the hospital and continuing in the outpatient setting.Funding Acknowledgements:This study was funded by Alkermes, Inc.

scholarly journals Efficacy and Safety of Human Placental Extract Solution on Fatigue: A Double-Blind, Randomized, Placebo-Controlled Study

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Kang-Kon Lee ◽  
Whan-Seok Choi ◽  
Keun-Sang Yum ◽  
Sang-Wook Song ◽  
Sun-Myeong Ock ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Study ◽  
Common Symptom ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Extract Solution ◽  
Group 2 ◽  
Fatigue Recovery ◽  
Placental Extract ◽  
Group 1

Introduction. Fatigue is a common symptom, but only a few effective treatments are available. This study was conducted to assess the efficacy and safety of the human placental extract solution, which has been known to have a fatigue recovery effect.Methods. A total of 315 subjects were randomly assigned to three groups: group 1 (with Unicenta solution administration), group 2 (with exclusively human placental extract administration, excluding other ingredients from the Unicenta solution), and the placebo group. Subsequently, solutions were administered for four weeks.Results. The fatigue recovery rate was 71.00% in group 1, 71.72% in group 2, and 44.21% in the placebo group, which show statistically significant differences between the group 1 and the placebo group (Pvalue = 0.0002), and between group 2 and the placebo group (Pvalue = 0.0001).Conclusion. The human placental extract solution was effective in the improvement of fatigue.

scholarly journals Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial

2015 ◽  
Vol 2015 ◽  
pp. 1-11 ◽  
Author(s):  
Tsuyoshi Miyaoka ◽  
Motohide Furuya ◽  
Jun Horiguchi ◽  
Rei Wake ◽  
Sadayuki Hashioka ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Treatment Resistant ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Intention To Treat ◽  
The Difference ◽  
The Individual

Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted.Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS).Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54:−0.23±0.08; placebo:−0.03±0.08,P<0.018), tension (TJ-54:−0.42±0.09; placebo:−0.18±0.09,P<0.045), and poor impulse control (TJ-54:−0.39±0.10; placebo:−0.07±0.10,P<0.037).Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.

scholarly journals Efficacy and Safety of MLC601 in the Treatment of Mild Cognitive Impairment: A Pilot, Randomized, Double-Blind, Placebo-Controlled Study

2017 ◽  
Vol 7 (1) ◽  
pp. 136-142 ◽  
Author(s):  
Hossein Pakdaman ◽  
Ali Amini Harandi ◽  
Mehdi Abbasi ◽  
Hosein Delavar Kasmaei ◽  
Farzad Ashrafi ◽  
...  
Keyword(s):  
Cognitive Impairment ◽  
Placebo Group ◽  
Mild Cognitive Impairment ◽  
Cognitive Function ◽  
Disease Assessment ◽  
Controlled Study ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Global Cognitive Function

Background and Aim: Mild cognitive impairment (MCI) is characterized by declined cognitive function greater than that expected for a person’s age. The clinical significance of this condition is its possible progression to dementia. MLC601 is a natural neuroprotective medication that has shown promising effects in Alzheimer disease. Accordingly, we conducted this randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of MLC601 in MCI patients. Methods: Seventy-two patients with a diagnosis of MCI were recruited. The included participants were randomly assigned to groups to receive either MLC601 or placebo. An evaluation of global cognitive function was performed at baseline as well as at 3-month and 6-month follow-up visits. Global cognitive function was assessed by Mini-Mental State Examination (MMSE) and Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) scores. Efficacy was evaluated by comparing global function scores between the 2 groups during the study period. Safety assessment included adverse events (AEs) and abnormal laboratory results. Results: Seventy patients completed the study, 34 in the MLC601 group and 36 in the placebo group. The mean changes (±SD) in cognition scores over 6 months in the MLC601 group were –2.26 (±3.42) for the MMSE and 3.82 (±6.16) for the ADAS-cog; in the placebo group, they were –2.66 (±3.43) for the MMSE and 4.41 (±6.66) for the ADAS-cog. The cognition changes based on both MMSE and ADAS-cog scores were statistically significant between the placebo and the MLC601 group (p < 0.001). Only 5 patients (14.7%) reported minor AEs in the MLC601 group, the most commonly reported of which were gastrointestinal, none of them leading to patient withdrawal. Conclusion: MLC601 has shown promising efficacy and acceptable AEs in MCI patients.

scholarly journals Efficacy and Safety of Praziquantel for Treatment of Schistosoma mansoni Infection among School Children in Tanzania

Pathogens ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. 28 ◽  
Author(s):  
Rajabu Hussein Mnkugwe ◽  
Omary S. Minzi ◽  
Safari M. Kinung’hi ◽  
Appolinary A. Kamuhabwa ◽  
Eleni Aklillu
Keyword(s):  
Abdominal Pain ◽  
Single Dose ◽  
Adverse Events ◽  
Schistosoma Mansoni ◽  
Infection Intensity ◽  
Post Treatment ◽  
Stool Examination ◽  
Efficacy And Safety ◽  
Cure Rate ◽  
Pre Treatment

Single-dose targeted praziquantel preventive chemotherapy is the WHO-recommended intervention for schistosomiasis control in endemic countries. The objective of this study was to assess the efficacy and safety of single-dose praziquantel among Schistosoma mansoni-infected children in north-western Tanzania. A prospective safety and efficacy surveillance study was conducted among 341 school-going children treated with a single-dose praziquantel 40 mg/kg body weight. Socio-demographic, pre-treatment, and post-treatment stool examination and safety data were collected. The primary and secondary outcomes were treatment efficacy (parasitological cure and egg reduction rates at three weeks post-treatment) and treatment-related adverse events, respectively. The overall cure rate and egg reduction rate were 81.2% (76.8–85.3%) and 95.0% (92.7–97.3%), respectively. There was no significant association between cure rate and pre-treatment infection intensity. The incidence of treatment-associated adverse events was 28.5% (23.7–33.3%), with abdominal pain being the most common. Post-treatment abdominal pain and vomiting were significantly associated with pre-treatment infection intensity (p < 0.001) and anemia (p = 0.03), respectively. Praziquantel single-dose is still safe and efficacious against Schistosoma mansoni infection. However, the lack of cure in about one-fifth and adverse events in a quarter, of the infected children indicate the need for close praziquantel safety monitoring and treatment optimization research to improve efficacy.

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.

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