scholarly journals Efficacy and Safety of the Cudrania tricuspidata Extract on Functional Dyspepsia: A Randomized Double-Blind Placebo-Controlled Multicenter Study

2021 ◽  
Vol 10 (22) ◽  
pp. 5323
Author(s):  
Jinyoung Shin ◽  
Tae-Hoon Oh ◽  
Joo-Yun Kim ◽  
Jae-Jung Shim ◽  
Jung-Lyoul Lee
Keyword(s):  
Functional Dyspepsia ◽  
Rating Scale ◽  
Gastrointestinal Symptoms ◽  
Controlled Study ◽  
Caffeine Intake ◽  
Control Group ◽  
Double Blind ◽  
Cudrania Tricuspidata ◽  
Double Blind Placebo ◽  
Folk Remedy

Cudrania tricuspidata is a folk remedy used to treat inflammation in patients with tumors or liver damage. This study investigated the efficacy of Cudrania tricuspidata extract (CTE) for relieving the symptoms of functional dyspepsia. In an 8-week, randomized, double-blind, placebo-controlled study, 100 adults with any condition featured in the Rome IV criteria and a Gastrointestinal Symptoms Scale (GIS) score ≥4 were randomly allocated to take either a placebo (maltodextrin) or a 50 mg CTE tablet, which equally included celluloses, magnesium stearate, and silicon dioxide, twice daily, 20 January 2020, and 3 August 2020. Among the 83 participants finally analyzed, the CTE group was associated with a significant reduction in the gastrointestinal symptom rating scale (day 0: 8.0 ± 5.2, day 28: 4.7 ± 3.9, and day 56: 2.3 ± 2.4, p < 0.001, respectively) in comparison with the control group (day 0: 8.1 ± 4.7, day 28: 7.8 ± 5.7, and day 56: 7.5 ± 6.6, p > 0.05) after adjusting for smoking, drinking, eating habits, stress levels, and caffeine intake. The CTE group resulted in significant improvements of GIS, Nepean Dyspepsia Index (Korean version), and functional dyspepsia-related quality of life over time. There were no different adverse events (p = 0.523). These findings suggest that CTE is safe and efficacious for alleviating gastrointestinal symptoms in patients with functional dyspepsia.

scholarly journals Randomized, Double-Blind, Placebo-Controlled Study of Modified Erzhi Granules in the Treatment of Menopause-Related Vulvovaginal Atrophy

2018 ◽  
Vol 2018 ◽  
pp. 1-15
Author(s):  
Ranran Chen ◽  
Dianrong Song ◽  
Wei Zhang ◽  
Guanwei Fan ◽  
Yingqiang Zhao ◽  
...  
Keyword(s):  
Drug Withdrawal ◽  
Endometrial Thickness ◽  
Vaginal Epithelium ◽  
Controlled Study ◽  
Control Group ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Vulvovaginal Atrophy ◽  
Normal Ranges ◽  
And Control

Objective. To evaluate the clinical therapeutic efficacy and safety of modified Erzhi granules (MEG) in patients with menopause-related vulvovaginal atrophy (VVA). Methods. This randomized, double-blind, placebo-controlled study comprised two groups, including the treatment and control groups. Patients receive MEG and placebo for 12 weeks, respectively. Vaginal health score (VHS), vaginitis score, vaginal maturation index (VMI), female sexual function index (FSFI), and modified Kupperman Index (modified KI) were used as efficacy endpoints and assessed at baseline, 4, 8, and 12 weeks during administration, and 4 weeks after drug withdrawal. At baseline and 12 weeks, serum estradiol (E2), follicle stimulating hormone (FSH), pelvic ultrasound, breast ultrasound, and other safety parameters were measured, recording adverse events. Results. At 12 weeks, VHS, percentage of superficial cells in the vaginal epithelium and FSFI were significantly increased, while vaginitis score, percentage of basal cells in the vaginal epithelium, and modified KI were significantly decreased in comparison with baseline and control group (all P<0.05); these differences persisted for up to 4 weeks after drug withdrawal. The placebo group showed no significant change during treatment compared with baseline values (p>0.05). Serum E2 and FSH levels, endometrial thickness, and breast thickness in all patients were within the normal ranges before and after treatment, with no serious adverse reactions observed. Conclusion. MEG significantly alleviates menopause-related vulvovaginal atrophy, with no overt adverse effects on the endometrium, breast, hepatic, and renal functions.

scholarly journals Evaluation of the Safety and Efficacy of a Multienzyme Complex in Patients with Functional Dyspepsia: A Randomized, Double-Blind, Placebo-Controlled Study

2018 ◽  
Vol 21 (11) ◽  
pp. 1120-1128 ◽  
Author(s):  
Muhammed Majeed ◽  
Shaheen Majeed ◽  
Kalyanam Nagabhushanam ◽  
Sivakumar Arumugam ◽  
Anurag Pande ◽  
...  
Keyword(s):  
Functional Dyspepsia ◽  
Controlled Study ◽  
Multienzyme Complex ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Double Blind Placebo

Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽  
2005 ◽  
Vol 10 (6) ◽  
pp. 3-5
Author(s):  
Richard H. Weisler
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Study ◽  
Mixed States ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

CNS Spectrums ◽  
2005 ◽  
Vol 10 (S1) ◽  
pp. 3-5
Author(s):  
Richard H. Weisler
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Controlled Trial ◽  
Controlled Study ◽  
Mixed States ◽  
Open Label ◽  
Young Mania ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Bipolar Patients

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

scholarly journals Effectiveness ofLactobacillus helveticusandLactobacillus rhamnosusfor the management of antibiotic-associated diarrhoea in healthy adults: a randomised, double-blind, placebo-controlled trial

2016 ◽  
Vol 116 (1) ◽  
pp. 94-103 ◽  
Author(s):  
Malkanthi Evans ◽  
Ryan P. Salewski ◽  
Mary C. Christman ◽  
Stephanie-Anne Girard ◽  
Thomas A. Tompkins
Keyword(s):  
Rating Scale ◽  
Gastrointestinal Symptoms ◽  
Healthy Adults ◽  
Lactobacillus Helveticus ◽  
Primary Study ◽  
Gastrointestinal Microbiota ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Probiotic Intervention ◽  
Antibiotic Associated Diarrhoea

AbstractBroad-spectrum antibiotic use can disrupt the gastrointestinal microbiota resulting in diarrhoea. Probiotics may be beneficial in managing this type of diarrhoea. The aim of this 10-week randomised, double-blind, placebo-controlled, parallel study was to investigate the effect ofLactobacillus helveticusR0052 andLactobacillus rhamnosusR0011 supplementation on antibiotic-associated diarrhoea in healthy adults. Subjects were randomised to receive 1 week of amoxicillin–clavulanic acid (875 mg/125 mg) once per day, plus a daily dose of 8×109colony-forming units of a multi-strain probiotic (n80) or placebo (n80). The probiotic or placebo intervention was maintained for 1 week after completion of the antibiotic. Primary study outcomes of consistency and frequency of bowel movements were not significantly different between the probiotic and placebo groups. The secondary outcomes of diarrhoea-like defecations, Gastrointestinal Symptoms Rating Scale scores, safety parameters and adverse events were not significantly different between the probiotic intervention and the placebo. Apost hocanalysis on the duration of diarrhoea-like defecations showed that probiotic intervention reduced the length of these events by 1 full day (probiotic, 2·70(sem0·36) d; placebo, 3·71 (sem0·36) d;P=0·037; effect size=0·52). In conclusion, this study provides novel evidence thatL. helveticusR0052 andL. rhamnosusR0011 supplementation significantly reduced the duration of diarrhoea-like defecations in healthy adults receiving antibiotics.

Sign in / Sign up

Export Citation Format

Share Document