Efficacy and Safety of Different Doses of Vaginal Misoprostol Prior to Intra Uterine Contraceptive Device Insertion: A Randomized Double-Blind Clinical Trial

QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Shaimaa G Helmy ◽  
Mohammed A El-Kadi ◽  
Mohamed E Elhodiby ◽  
Mohamed H Salama
Keyword(s):  
Controlled Trial ◽  
Secondary Outcome ◽  
Contraceptive Device ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Group 3 ◽  
Group 2 ◽  
Vaginal Misoprostol ◽  
Different Doses ◽  
Group 1

Abstract Objective This study aims to compare the efficacy and safety of different doses of vaginal misoprostol prior to IUCD insertion among women with nulliparous cervix “those who 29never delivered-vaginally”. Study design: The current study was a randomized, double-blind, placebo-controlled trial conducted in the Family Planning Clinic of Ain Shams University’s Maternity Hospital Egypt. It involved women who delivered only by elective CD (cesarean delivery). One hundred and eighty women were randomized into three groups, Group 1 received misoprostol 200 mcg. Group 2 received misoprostol 100 mcg. Group 3 received placebo. The primary outcome was pain scores which were measured using a visual analogue scale (VAS), the secondary outcome was the ease of insertion score (ES). Results VAS and ES were significantly lower in group 1 compared to group 2 and group 3 (P < 0.001).There was insignificant difference among the three groups as regards successful IUD insertion (P = 0.477). Duration of insertion was significantly lower in group 1 than group 2 (P < 0.001). Satisfaction was significantly higher in group 1 compared to group 2 and group 3 (P < 0.001) Conclusion The effect of misoprostol seems to be dose-dependent. Dose of 200mcg seems to be ideal with best efficacy and with no significant increase in the adverse effects Implications: The dose of 200mcg vaginal misoprostol prior to IUD insertion in women, who had never delivered vaginally before, seems to be the most effective dose. Trail to lower the dose to100mcg significantly compromises the efficacy without remarkable benefit on the side effect profile.

Fibrin gel versus papain gel in the healing of chronic venous ulcers: A double-blind randomized controlled trial

2016 ◽  
Vol 32 (7) ◽  
pp. 488-495 ◽  
Author(s):  
Illymack CF de Araújo ◽  
Elenice Defune ◽  
Luciana PF Abbade ◽  
Hélio A Miot ◽  
Matheus Bertanha ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Efficacy And Safety ◽  
Fibrin Gel ◽  
Double Blind ◽  
Randomized Controlled ◽  
Carbopol Gel ◽  
Venous Ulcers ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objectives Compare the efficacy and safety of fibrin gel to 8% papain gel for wound dressing of venous ulcers. Method Patients with chronic venous ulcers were randomly assigned to one in three groups: Group 1—fibrin gel; Group 2—8% papain gel; Group 3—carbopol gel (control). Patients were seen every 15 days during 2 months, verifying reduction of the ulcer area, local infection, exudation, and epithelization. All serious or nonserious adverse events were recorded. Results Fifty-five patients (total of 63 ulcers) were randomly distributed in three groups (G1 = 21; G2 = 19; G3 = 23). No patient was excluded or discontinued treatment throughout the study. The areas of the ulcers were similarly reduced in all groups (14.3%, 21.1%, and 30.4% in groups 1, 2, and 3, respectively), and all had significant reduction in exudation and contamination. Conclusion The data demonstrate that neither fibrin gel nor papain gel were able to improve the process of ulcer-healing, as compared to control.

scholarly journals Efficacy and safety of Ivermectin and Hydroxychloroquine in patients with severe COVID-19. A randomized controlled trial

2021 ◽  
Author(s):  
Jose Lenin Beltran Gonzalez ◽  
Mario González Gámez ◽  
Emanuel Antonio Mendoza Enciso ◽  
Ramiro Josue Esparza Maldonado ◽  
Daniel Hernández Palacios ◽  
...  
Keyword(s):  
Respiratory Failure ◽  
Controlled Trial ◽  
Total Duration ◽  
Severe Respiratory Failure ◽  
Double Blind ◽  
Arterial Blood ◽  
Duration Of Hospitalization ◽  
Group 3 ◽  
Group 2

AbstractBackgroundIn the search for active drugs against COVID-19, the indications of many have been redirected. Ivermectin and Hydroxychloroquine are drugs that inhibit viral replication in vitro and that have been used in several medical centers.ObjectivesThis clinical trial analyzes the efficacy of Ivermectin and Hydroxychloroquine in patients with moderate COVID-19 and in need of hospitalization.MethodsThis a controlled, clinical, randomized, double-blind trial that included patients with COVID-19-induced pneumonia and hospitalization criteria, but no severe respiratory failure. Patients were randomized to one of three groups: Group1-hydroxychloroquine, 400 mg every 12 hours on the first day and subsequently, 200 mg every 12 hours for 4 days, Group 2-ivermectin, 12 mg or 18 mg, according to patient weight and, Group 3-placebo. At inclusion, blood samples for arterial blood gases and biochemical markers associated with a poor prognosis were obtained. The primary outcome was established as the duration of hospitalization until discharge due to patient improvement, the total duration of hospitalization, and the safety outcomes were either respiratory deterioration or death.ResultsDuring the month of August, the admission of patients requiring hospitalization mostly encompassed cases with severe respiratory failure, so we ended the recruitment process and analyzed the data that was available at the time. One hundred and six (106) patients with an average age of 53 yrs. (±16.9) were included, with a greater proportion of males (n=66, 62.2 %). Seventy-two percent (72%) (n= 76) had an associated comorbidity. Ninety percent (90 %) of patients were discharged due to improvement (n=96). The average duration of hospitalization was 6 days (IQR, 3 – 10). No difference in hospitalization duration was found between the treatment groups (Group1: 7 vs Group 2: 6 vs Group 3: 5, p=0.43) nor in respiratory deterioration or death (Group 1: 18 % vs Group 2: 22.2 % vs Group 3: 24.3 %, p =0.83).ConclusionsIn non-critical hospitalized patients with COVID-19 pneumonia, neither ivermectin nor hydroxychloroquine decreases the number of in-hospital days, respiratory deterioration, or deaths.ClinicalTrials identifier NCT04391127

scholarly journals Pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal anti-SARS-CoV-2 antibody, for COVID-19-related moderate pneumonia: a randomized, double-blind, placebo-controlled, phase IIa study

2021 ◽  
Author(s):  
Benjamin Gaborit ◽  
Eric Dailly ◽  
Bernard Vanhove ◽  
Régis Josien ◽  
Karine Lacombe ◽  
...  
Keyword(s):  
Adverse Events ◽  
High Serum ◽  
Serum Concentrations ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Good Tolerability ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objective: We assessed the pharmacokinetics and safety of XAV-19, a swine glyco-humanized polyclonal antibody against SARS-CoV-2, in COVID-19-related moderate pneumonia. To evaluate the optimal dose and safety of XAV-19 during this first administration to patients with COVID-19-related moderate pneumonia. Methods : In this phase 2a trial, adults with COVID-19-related moderate pneumonia of ≤10 days duration were randomized to infusion of XAV-19 0.5mg/kg at day 1 and day 5 (group 1), 2mg/kg at day 1 and day 5 (group 2), 2mg/kg at day 1 (group 3) or placebo. Results : Eighteen patients (n=7 for group 1, n=1 for group 2, n=5 for group 3, and n=5 for placebo) were enrolled. Baseline characteristics were similar across groups, XAV-19 serum concentrations (μg/mL, median, range) at C max and at day 8 were 9.1 (5.2-18.1) and 6.4 (2.8-11.9), 71.5 and 47.2, and 50.4 (29.1-55.0) and 20.3 (12.0-22.7) for groups 1, 2 and 3, respectively (p=0.012). Terminal half-life (median, range) was estimated at 11.4 (5.5-13.9) days for 2 mg/kg of XAV-19 at day 1. Serum XAV-19 concentrations were above the target concentration of 10 μg/mL (tow fold the in vitro 100% inhibitory concentration [IC 100 ]) from the end of perfusion to more than 8 days for XAV-19 2 mg/kg at day 1. No hypersensitivity or infusion-related reactions were reported during treatment, there was no discontinuation for adverse events and no serious adverse events related to study drug. Conclusions : Single intravenous dose of 2mg/kg of XAV-19 demonstrated high serum concentrations, predictive of potent durable neutralizing activity with good tolerability. Trial registration: ClinicalTrials.gov Identifier: NCT04453384

scholarly journals Clinical Efficacy and Safety of Thai Herbal Formulation-6 in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized-Controlled Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Nut Koonrungsesomboon ◽  
Saowaros Nopnithipat ◽  
Supanimit Teekachunhatean ◽  
Natthakarn Chiranthanut ◽  
Chaichan Sangdee ◽  
...  
Keyword(s):  
Knee Pain ◽  
Controlled Trial ◽  
Common Adverse Event ◽  
Mean Difference ◽  
Secondary Outcome ◽  
Osteoarthritis Of The Knee ◽  
Efficacy And Safety ◽  
Short Term Treatment ◽  
Double Blind ◽  
Herbal Formulation

Background. Osteoarthritis of the knee is the most common form of arthritis. Identifying effective and safe herbal formulations that are locally available is viewed as a priority for sustainable development in a region. This study aimed to evaluate the efficacy and safety of Thai herbal formulation-6 (THF-6) in comparison with oral diclofenac in patients with moderate-to-severe osteoarthritis of the knee. Methods. This randomized, double-blind, active-controlled, noninferiority trial randomly assigned patients with osteoarthritis of the knee to receive either THF-6 or diclofenac for four weeks. The primary outcome measure was the change from baseline in knee pain as measured by a 100 mm visual analog scale (VAS). Secondary outcome measures included knee stiffness, a stair climb test, the Knee Injury and Osteoarthritis Outcome Score, and safety parameters. Outcomes were assessed on a biweekly basis. Modified intention-to-treat (MITT) and perprotocol (PP) analyses were applied. Results. A total of 200 patients were enrolled of whom 175 (87.5%) were included in the MITT analysis and 153 (76.5%) in the PP analysis. The mean change in VAS pain did not differ between the two groups, and the upper limit of the two-sided 95% confidence interval (CI) for comparison between the two groups was within the prespecified margin of 10 mm for noninferiority (MITT analysis: mean difference = 0.86, 95% CI = -4.39 to 6.10, p = 0.748 ; PP analysis: mean difference = 1.98, 95% CI = -3.61 to 7.56, p = 0.486 ). Significant improvement was observed in all the efficacy parameters in both groups. Dyspepsia was the most common adverse event: 23 patients in the THF-6 group and 28 in the diclofenac group p = 0.417 . Conclusions. THF-6 offers an alternative to oral diclofenac for the short-term treatment of osteoarthritis of the knee. It was shown to be noninferior to oral diclofenac in relieving knee pain. This trial is registered with ChiCTR-IPR-15007213.

Effect of Chlorhexidine Cleansing of Umbilical Cord for Prevention of Infection

2018 ◽  
Vol 4 (2) ◽  
pp. 35-39
Author(s):  
Md Khairuzzaman ◽  
MA Mannan ◽  
Abdul Matin ◽  
Mst Monjuman Ara Sarker ◽  
Nihar Ranjan Sarker ◽  
...  
Keyword(s):  
Umbilical Cord ◽  
Controlled Trial ◽  
Care Group ◽  
Cord Care ◽  
Randomized Controlled ◽  
Group 3 ◽  
Group 2 ◽  
To Receive ◽  
Level Hospital ◽  
Group 1

Background: Chlorhexidine cleansing of the cord can reduce neonatal mortality among newborns.Objective: The aim of study was to determine the effect of cord cleansing with chlorhexidine in reduction of umbilical infection among newborns in hospital settings.Methodology: This randomized controlled trial was carried out between April 2013 to July 2014 and 510 newborns were randomly assigned within a tertiary level hospital in Bangladesh to receive 1 of 3 cord care regimens single cord cleansing with 4% chlorhexidine(Group-1), multiple cord cleansing with 4% chlorhexidine (Group-2)  and clean and dry cord care (Group-3 : control).Results: The risk of umbilical cord infection (omphalitis) was significantly reduced in both the single (Relative risk [RR] 0.15 [95% CI] 0.008-0.93) and multiple chlorhexidine cleansing group (RR 0.37 [95% CI] 0.04- 0.99) compared to the dry cord care group.  The risk of omphalitis was not significantly different between multiple and single chlorhexidine cleansing group (RR 3.14 [0.13-76.54]). Conclusion: Chlorhexidine significantly reduce the risk of umbilical infection in both single and multiple cord cleansing neonates.Bangladesh Journal of Infectious Diseases 2017;4(2):35-39

scholarly journals EFFICACY OF MOUTH RINSE FORMULATION BASED ON CETYLPYRIDINIUM CHLORIDE 0.1% IN THE CONTROL OF DENTAL CALCULUS BUILDUP

2017 ◽  
Vol 9 ◽  
pp. 176 ◽  
Author(s):  
Diah Ayu Maharani ◽  
Alia Ramadhani ◽  
Melissa Adiatman ◽  
Yuniardini Septorini Wimardhani ◽  
Linda Kusdhany ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cetylpyridinium Chloride ◽  
Positive Control ◽  
Negative Control ◽  
Mouth Rinse ◽  
Dental Calculus ◽  
Double Blind ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

Objective: This study aimed at comparing the antiplaque, anticalculus, and antigingivitis potentials of a mouth rinse containing essential oil, alcohol,zinc, and fluoride with a mouth rinse containing cetylpyridinium chloride (CPC) 0.1% over 1-, 2-, and 3-month periods.Methods: This study was a double-blind, parallel randomized clinical trial with a 3-day run-in phase. Respondents were asked to gargle twice dailywith 15 ml of mouth rinse for 30 seconds after brushing teeth. Respondents were 80 females with a mean age of 21 years, and a single dental examinerwas employed throughout the study to decrease the variance. Prophylaxis was performed for all respondents before the intervention. Three mouthrinses were tested: Group 1 with the mouth rinse containing CPC 0.1%, Group 2 as the negative control, and Group 3 as the positive control with amouth rinse containing alcohol. Evaluations were conducted by plaque index, gingival index, calculus index, and CariScreen examinations.Results: The clinical trial showed that the mouth rinse with alcohol and the mouth rinse containing CPC 0.1% were effective in inhibiting bacterialbuildup (antiplaque) and have anticalculus properties, but with no statistically significant antigingivitis effect.Conclusion: It was found that the mouth rinse containing alcohol has similar effectiveness with CPC 0.1% mouth rinse, but side effects, such as aburning sensation, were reported in the alcohol-containing mouth rinse.

scholarly journals Prevention of Delayed Nausea: A University of Rochester Cancer Center Community Clinical Oncology Program Study of Patients Receiving Chemotherapy

2012 ◽  
Vol 30 (27) ◽  
pp. 3389-3395 ◽  
Author(s):  
Joseph A. Roscoe ◽  
Charles E. Heckler ◽  
Gary R. Morrow ◽  
Supriya G. Mohile ◽  
Shaker R. Dakhil ◽  
...  
Keyword(s):  
Statistical Significance ◽  
Cancer Center ◽  
Double Blind ◽  
Group 4 ◽  
Community Clinical Oncology Program ◽  
Delayed Nausea ◽  
Group 3 ◽  
Group 2 ◽  
Mean Differences ◽  
Group 1

Purpose We conducted a double-blind randomized clinical trial of the following four regimens for controlling delayed nausea (DN): group 1: palonosetron + dexamethasone on day 1 with prochlorperazine on days 2 and 3; group 2: granisetron + dexamethasone on day 1 with prochlorperazine on days 2 and 3; group 3: aprepitant + palonosetron + dexamethasone on day 1 with aprepitant + dexamethasone on days 2 and 3; and group 4: palonosetron + dexamethasone on day 1 with prochlorperazine + dexamethasone on days 2 and 3. Patients and Methods Chemotherapy-naive patients received doxorubicin, epirubicin, cisplatin, carboplatin, or oxaliplatin. The primary end point was average nausea assessed four times daily on days 2 and 3. Primary analyses were whether nausea control would be improved by using palonosetron versus granisetron on day 1 (group 1 v group 2); by adding dexamethasone on days 2 and 3 (group 1 v group 4); and by using aprepitant versus prochlorperazine (group 3 v group 4). Statistical significance was set at P = .017. Results Two hundred thirty-four, 234, 241, and 235 evaluable patients were accrued to groups 1, 2, 3, and 4, respectively. Adjusted mean differences for the three planned analyses were as follows: palonosetron versus granisetron: −0.01 (95% CI, −0.23 to 0.20; P = .72); adding dexamethasone on days 2 and 3: 0.20 (95% CI, −0.02 to 0.41; P = .01); and using aprepitant versus prochlorperazine: −0.03 (95% CI, −0.24 to 0.19; P = .56). Conclusion The addition of dexamethasone on days 2 and 3 reduced DN. Palonosetron and granisetron have similar effects on DN. The beneficial effect of adding aprepitant for control of DN was the same as adding prochlorperazine.

scholarly journals Randomized, Controlled Trial of a 13-Valent Pneumococcal Conjugate Vaccine Administered Concomitantly with an Influenza Vaccine in Healthy Adults

2012 ◽  
Vol 19 (8) ◽  
pp. 1296-1303 ◽  
Author(s):  
Robert W. Frenck ◽  
Alejandra Gurtman ◽  
John Rubino ◽  
William Smith ◽  
Martin van Cleeff ◽  
...  
Keyword(s):  
Influenza Vaccine ◽  
Conjugate Vaccine ◽  
Pneumococcal Conjugate Vaccine ◽  
Controlled Trial ◽  
Geometric Mean ◽  
Enzyme Linked Immunosorbent Assay ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Group 2 ◽  
Group 1

ABSTRACTA randomized, double-blind, phase 3 trial evaluated the immunogenicity, safety, and tolerability of a 13-valent pneumococcal conjugate vaccine (PCV13) coadministered with trivalent inactivated influenza vaccine (TIV) in pneumococcal vaccine-naive adults. Participants ages 50 to 59 years (n= 1,116) received TIV with PCV13 (group 1) or placebo (group 2) (1:1 randomization); 1 month later, group 1 received placebo and group 2 received PCV13. A hemagglutination inhibition (HAI) assay for TIV and a standardized enzyme-linked immunosorbent assay for pneumococcal serotype-specific immunoglobulin G (IgG) were performed and opsonophagocytic activity (OPA) titers (assessedpost hoc) were measured at baseline and 1 and 2 months postvaccination. The rises in HAI assay geometric mean titer (GMT) and percentage of participants in groups 1 and 2 with ≥4-fold increases in HAI responses (A/H1N1, 84.0% and 81.2%, respectively; A/H3N2, 71.1% and 69.5%, respectively; and B, 60.6% and 60.3%, respectively) were similar. In group 1, all serotypes met the predefined IgG geometric mean concentration (GMC) ratio noninferiority criterion relative to group 2, but GMCs were lower in group 1 than group 2. When comparing group 1 with group 2, 5 serotypes did not meet the OPA GMT ratio noninferiority criterion, and OPA GMTs were significantly lower for 10 serotypes. PCV13 injection site reactions were similar and mostly mild in both groups. Systemic events were more frequent in group 1 (86.2%) than group 2 (76.7%;P< 0.001); no vaccine-related serious adverse events occurred. Coadministration of PCV13 and TIV was well tolerated but associated with lower PCV13 antibody responses and is of unknown clinical significance. Given the positive immunologic attributes of PCV13, concomitant administration with TIV should be dictated by clinical circumstances.

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.

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