Evaluation of a mouthrinse containing guava leaf extract as part of comprehensive oral care regimen- a randomized placebo-controlled clinical trial

Abstract Background The control of biofilm adherence on tooth surface has always been the keystone of periodontal therapeutic systems. However, prevalence of gingivitis suggest inadequacy of self-performed oral hygiene measures and need for adjunctive aid for mechanical plaque control. Oral rinses containing chlorhexidine, has been widely used however, with certain limitations. Herbal products have been used widely reflecting its action as alternative and complementary remedy. Hence, the purpose of the present study was to evaluate the antimicrobial and antioxidant efficacy of a Guava leaf extract based mouthrinse in patients with chronic generalized gingivitis as an adjunct to oral prophylaxis. Methods Sixty subjects (n = 20) in compliance with the inclusion criteria were randomly assigned to one of the 3 study groups i.e. Group A- 0.15%Guava mouth rinse, Group B- 0.2% Chlorhexidine (CHX) mouth rinse, Group C- Distilled water (placebo). All the participants received professional oral prophylaxis and were dispensed with experimental mouth rinses and instructed to use for period of 30 days. Clinical parameters such as gingival index, plaque index along with microbial colony forming units using plaque samples and antioxidant levels in saliva were estimated at baseline, 30 and 90 days’ time intervals. Results All 3 groups showed gradual reduction in GI, PI and microbial counts. Considering the mean scores of recorded parameters at the scheduled time intervals, notable changes were observed between chlorhexidine and guava mouth rinse compared to placebo group. Although there was improvement in the antioxidant status in all study participants, yet there was no statistically significant difference observed. Conclusion Guava mouth rinse can be used as an empirical adjunct to professional oral prophylaxis owing to its multifactorial properties and favourable acceptance. However, long term studies need to be conducted to validate its use for an extended period of time. Trial registration The clinical trial has been prospectively registered on 17th February 2017 by the Clinical Trials Registry-India (CTRI/2017/02/007898).

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Comparing the efficacy and side-effects of PDLASTA® (Pegfilgrastim) with PDGRASTIM® (Filgrastim) in breast cancer patients: a non-inferiority randomized clinical trial

BMC Cancer ◽

10.1186/s12885-021-08197-6 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Safa Najafi ◽

Maryam Ansari ◽

Vahid Kaveh ◽

Shahpar Haghighat

Keyword(s):

Breast Cancer ◽

Clinical Trial ◽

Single Dose ◽

Side Effects ◽

Randomized Clinical Trial ◽

Cancer Patients ◽

Injection Site Reaction ◽

Study Groups ◽

Breast Cancer Patients ◽

Significant Difference

Abstract Background The objective of this study was to compare the efficacy and side effects of a single dose (Pegfilgrastim or PDL) or repeated six daily injections (Filgrastim or PDG) during chemotherapy courses in breast cancer patients in a non-inferiority clinical trial. Methods In this randomized clinical trial, 80 patients were recruited and allocated randomly to two equal arms. In one group, a single subcutaneous dose of PDL was injected the day after receiving the chemotherapy regimen in each cycle. The second arm received a subcutaneous injection of PDG for six consecutive days in each cycle of treatment. The side effects of GCF treatment and its effect on blood parameters were compared in each cycle and during eight cycles of chemotherapy. Results Hematologic parameters showed no significant differences in any of the treatment courses between the two study groups. The comparison of WBC (p = 0.527), Hgb (p = 0.075), Platelet (p = 0.819), Neutrophil (p = 0.575), Lymphocyte (p = 705) and ANC (p = 0.675) changes during the eight courses of treatment also revealed no statistically significant difference between the two study groups. Side effects including headache, injection site reaction and muscle pain had a lower frequency in patients receiving PDL drugs. Conclusion It seems that PDL is non-inferior in efficacy and also less toxic than PDG. Since PDL can be administered in a single dose and is also less costly, it can be regarded as a cost-effective drug for the treatment of chemotherapy-induced neutropenia. Trial registration IRCT20190504043465N1, May 2019.

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The effect of oat bran consumption on gestational diabetes: a randomized controlled clinical trial

BMC Endocrine Disorders ◽

10.1186/s12902-021-00731-8 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Zahra Barati ◽

Mina Iravani ◽

Majid Karandish ◽

Mohammad Hosein Haghighizadeh ◽

Sara Masihi

Keyword(s):

Clinical Trial ◽

Blood Glucose ◽

Gestational Diabetes ◽

Fasting Blood Glucose ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Standard Diet ◽

Oat Bran ◽

Significant Difference

Abstract Background Gestational diabetes is the most common medical complication in pregnancy, and it has many side effects for the mother and the fetus. The aim of this study was to evaluate the effect of oat bran consumption on gestational diabetes. Methods This study is a randomized clinical trial that was performed on 112 women with gestational diabetes treated with diet. Participants were randomly divided into two groups of 56. Participants in both groups were given a diet for gestational diabetes. In addition to the diet, the intervention group received 30 g of oat bran daily for 4 weeks at lunch and dinner. Tests of fasting blood glucose and two-hour postprandial (2hpp) glucose were taken from both groups: before the intervention, and 2 and 4 weeks after the start of the intervention. Data analysis was performed using SPSS statistical software (version 22) using independent t-test, as well as Chi-square and Mann-Whitney tests. P values less than 0.05 were considered statistically significant. Results There was no statistically significant difference between the two groups in terms of mean blood glucose before the intervention, while 2 and 4 weeks after the intervention, mean fasting blood glucose and two-hour postprandial (2hpp) glucose decreased significantly in the intervention group compared with the control group (P < 0.001). Conclusion Based on the results of this study, the addition of oat bran to the standard diet for pregnant women with gestational diabetes reduced fasting blood glucose and two-hour postprandial (2hpp) glucose. More detailed studies with higher sample sizes are recommended to prove the effectiveness of this valuable dietary supplement. Trial registration IRCT registration number:IRCT20191220045828N1. Registration date: 2020-04-18. Registered while recruiting.

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Standard versus Endocuff versus cap-assisted colonoscopy for adenoma detection: A randomised controlled clinical trial

United European Gastroenterology Journal ◽

10.1177/2050640620982952 ◽

2020 ◽

pp. 205064062098295

Author(s):

Martin Floer ◽

Laura Tschaikowski ◽

Michael Schepke ◽

Radoslaw Kempinski ◽

Katarzyna Neubauer ◽

...

Keyword(s):

Clinical Trial ◽

Cancer Screening ◽

Controlled Clinical Trial ◽

Polyp Detection ◽

Withdrawal Time ◽

Adenoma Detection ◽

Significant Difference ◽

Randomised Controlled Clinical Trial ◽

Randomised Controlled ◽

Standard Colonoscopy

Background and aims Adenoma detection rate (ADR) in colon cancer screening is most important for cancer prophylaxis. This work is the first three-armed randomised controlled clinical trial aimed at comparing a head-to-head setting standard colonoscopy (SC) with Endocuff-assisted colonoscopy (EC) and cap-assisted colonoscopy (CAC) for improvement of ADR. Methods Patients from Poland and Germany with independent indication for colonoscopy were randomised into three arms of this trial: EC, CAC and SC. Exclusion criteria were age <18 years, active Crohn’s disease or ulcerative colitis, known stenosis and post-colonic resection status. Results A total of 585 patients (195 SC, 189 EC and 186 CAC) were enrolled in this study. Indications were not different between the groups (colorectal cancer screening 51%, diagnostic colonoscopy in 31% and post polypectomy follow-up in 18%; p=0.94). Withdrawal time was a mean of seven minutes in all groups ( p=0.658), and bowel preparation did not differ between the groups. The time to reach the caecum was significantly reduced when using the cap (a mean of six minutes for CAC vs. seven minutes for SC; p=0.0001). There was no significant difference in the primary outcome of the ADR between the groups (EC 32%, CAC 30%, SC 30%; p=0.815). EC proved to be superior (EC vs. SC) in the sigmoid colon and transverse colon for polyp detection. Conclusion The use of EC increased the total number of polyps seen during colonoscopy. In contrast to recent studies, no significant improvement of the ADR was detected.

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A randomized controlled clinical trial of the effect of supportive counseling on mental health in Iranian mothers of premature infants

BMC Pregnancy and Childbirth ◽

10.1186/s12884-020-03502-w ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Leila Seiiedi-Biarag ◽

Mojgan Mirghafourvand ◽

Khalil Esmaeilpour ◽

Shirin Hasanpour

Keyword(s):

Mental Health ◽

Clinical Trial ◽

Premature Infants ◽

Control Group ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Randomized Controlled ◽

Significant Difference ◽

Postpartum Bonding ◽

Supportive Counseling

Abstract Background Premature birth can affect maternal mental health. Considering that the mental health disorder in mothers may play a vital role in the growth and development of their children, therefore, this study was conducted to determine the effect of supportive counseling on mental health (primary outcome), mother-child bonding and infant anthropometric indices (secondary outcomes) in mothers of premature infants. Methods This randomized controlled clinical trial was carried out on 66 mothers with hospitalized neonates in the NICU of Alzahra hospital in Tabriz- Iran. Participants were randomly allocated into two groups of intervention (n = 34) and control (n = 32) through a block randomization method. The intervention group received 6 sessions of supportive counseling (45–60 minutes each session) by the researcher, and the control group received routine care. Questionnaires of Goldberg General Health and the postpartum bonding were completed before the intervention (first 72 hours postpartum) and 8 weeks postpartum. Also, the anthropometric index of newborns were measured at the same time. Results There was no statistically significant difference between the two groups in terms of socio-demographic characteristics. After the intervention, based on ANCOVA with adjusting the baseline score, mean score of mental health (AMD: -9.8; 95% Confident Interval (95% CI): -12.5 to -7.1; P < 0.001) and postpartum bonding (AMD: -10.0; 95% CI: -0.6 to 13.9; P < 0.001) in the counseling group was significantly lower than those of the control group; however, in terms of weight (P = 0.536), height (P = 0.429) and head circumference (P = 0.129), there was no significant difference between the two groups. Conclusions Supportive counseling may improve mental health and postpartum bonding in mothers of premature infants. Thus, it may be recommendable for health care providers to offer it to mothers. Trial registration Iranian Registry of Clinical Trials (IRCT): IRCT20120718010324N45. Date of registration: October 29, 2018.

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Intravenous paracetamol versus ketorolac for pain attenuation in patients with renal colic; a randomized, single blind and controlled clinical trial

Journal of Renal Injury Prevention ◽

10.34172/jrip.2020.10 ◽

2020 ◽

Vol 9 (2) ◽

pp. e10-e10

Author(s):

Arash Ardestani Zadeh ◽

Davood Arab ◽

Mohammadreza Moonesan ◽

Majid Mirmohammadkhani ◽

Pouya Morid

Keyword(s):

Clinical Trial ◽

Adverse Effects ◽

Renal Colic ◽

Vital Signs ◽

Analgesic Efficacy ◽

Controlled Clinical Trial ◽

Randomized Controlled ◽

Intravenous Paracetamol ◽

Significant Difference ◽

Single Blind

Introduction: Pain control is an essential care for patients with renal colic in emergency wards. Objectives: This study aimed to compare the analgesic efficacy of intravenous (IV) paracetamol (PC) versus ketorolac (KET) for patients with renal colic. Patients and Methods: In a randomized controlled clinical trial, 110 patients with renal colic referred to the emergency department of Kosar hospital, Semnan between October 2015 and June 2016 were selected. Eighty-eight patients were divided into two groups (44 patients in each group) of PC (1 g/IV) and KET (30 mg/IV). One patient in each group was excluded during the study. Vital signs and pain severity (measured by visual analogue scale [VAS]) of all patients were recorded at admission time 0, 20, 40 and 60 minutes after treatment. Then, the results were compared in two groups. Results: The results showed that at the time of 0, 20, 40 and 60 minutes after the administration of the PC and KET drugs, no significant difference was seen in severity of pain based on VAS score between the two groups (P<0.05). Moreover, there were no significant differences in the vital signs of two groups (P<0.05). No adverse effects were reported in each group. Conclusion: In conclusion, the use of IV-PC and KET in patients with renal colic had similar pain relieving effects without any adverse effects.

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Preventive Efficacy of Dried Lime (Citrus aurantifulia) in Common Cold Among Hajj Pilgrims: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

Galen Medical Journal ◽

10.31661/gmj.v9i0.1462 ◽

2020 ◽

Vol 9 ◽

pp. e1462

Author(s):

Mehdi Pasalar ◽

Seyed Hamdollah Mosavat ◽

Hossein Molavi Vardanjani ◽

Mohsen Keshavarz ◽

Maryam Mosaffa-Jahromi ◽

...

Keyword(s):

Clinical Trial ◽

Placebo Group ◽

Common Cold ◽

Primary Outcome Measure ◽

Drug Group ◽

Controlled Clinical Trial ◽

Significant Difference ◽

Preventive Efficacy ◽

Double Blinded ◽

Self Administered Questionnaire

Background: Dried lime (Citrus aurantifulia) is one of the herbal preparations used especially by Iranian pilgrims as a preventative agent and self-remedy for respiratory tracts symptoms in folklore medicine. Therefore, we evaluated the preventive efficacy of dried lime preparation in common cold among Iranian pilgrims. Materials and Methods: In this randomized, double-blinded, clinical trial patients in the drug group received dried lime capsules, 500 mg in a single dose per day for four weeks. In the placebo group, the patients received placebo capsules using the same method. The primary outcome measure in this trial was the severity of cold symptoms assessed by a self-administered questionnaire. Results: There were no significant differences between the two groups in terms of the trend of cold symptoms severity during the study period. However, in the second week, the severity of all the cold symptoms in the drug group was less, compared to the placebo, but at the end of the study, comparison of the two groups revealed no significant difference in any of the investigated options. Conclusion: The findings revealed that although the severity of all the cold symptoms in the drug group was less as compared to the placebo group, the dried lime capsule showed no statistically significant effect on the control of these symptoms in Iranian pilgrims. [GMJ.2020;9:e1462]

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Impact of force magnitude on effectiveness in cervical headgear therapy: a cephalometric analysis

European Journal of Orthodontics ◽

10.1093/ejo/cjz022 ◽

2019 ◽

Vol 41 (6) ◽

pp. 646-651 ◽

Cited By ~ 1

Author(s):

Tuula H Talvitie ◽

Mika Helminen ◽

Susanna Karsila ◽

Reeta Varho ◽

Luca Signorelli ◽

...

Keyword(s):

Clinical Trial ◽

Controlled Clinical Trial ◽

Cephalometric Analysis ◽

Force Magnitude ◽

Lateral Cephalograms ◽

Significant Difference ◽

The Impact

Summary Aim The main aim of this study was to study the impact of different force magnitudes on effectiveness in cervical headgear (CHG) therapy. Materials and methods Forty patients were treated with CHG with light (L; 300 g) or heavy (H; 500 g) force in this controlled clinical trial. Patients were asked to wear CHG for 10 hours/day for 10 months. The inner bow of the CHG was expanded (3–4 mm) and the long outer bow bent (10–20 degree) upward in relation to the inner bow. Adherence to instructions and force magnitude in CHG use was monitored by electronic module (Smartgear, Swissorthodontics, Switzerland). Lateral cephalograms were taken before (T1) and after (T2) the treatment and studied with modified Pancherz analysis using a Planmeca Romexis Ceph module (Planmeca, Finland). Results In both groups, skeletal and dental effects were seen. The only statistically significant difference in cephalometric analysis was the inclination of upper incisors at T1 (P = 0.010) and at T2 (P = 0.011). In both groups, a reduction in Sella-Nasion- point A (SNA) angle was found: L group T1 82.7degree (SD ± 3.6degree), T2 82.0degree (SD ± 3.5 degree) and H group T1 82.6 degree (SD ± 4.7 degree), T2 81.5 degree (SD ± 4.5 degree), but no statistically significant difference between the groups. Children in the L group used CHG statistically significantly more than those in the H group (10.0 ± 1.5 hour, and 8.3 ± 2.1 hour, respectively, P = 0.002). Conclusion Children with lower force CHG seem to adhere better to instructions for CHG use. After 10 months of use, no statistically significant differences were found in dental or skeletal outcome. However, in the H group, the outcome was achieved with less daily hours of use.

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Effectiveness of a home care teaching program for prostatectomized patients: a randomized controlled clinical trial

Revista da Escola de Enfermagem da USP ◽

10.1590/s1980-220x2018012503421 ◽

2019 ◽

Vol 53 ◽

Author(s):

Luciana Regina Ferreira da Mata ◽

Cissa Azevedo ◽

Mariana Ferreira Vaz Gontijo Bernardes ◽

Tânia Couto Machado Chianca ◽

Maria da Graça Pereira ◽

...

Keyword(s):

Clinical Trial ◽

Home Care ◽

Self Efficacy ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Teaching Program ◽

Significant Difference ◽

The Times

ABSTRACT Objective: To evaluate the effectiveness of a teaching program for hospital discharge of patients submitted to radical prostatectomy based on the self-efficacy construct of the Cognitive Social Theory. Method: A controlled clinical trial carried out on a 2-month follow-up of 68 prostatectomized men randomized into intervention group (n = 34) and control (n = 34). The intervention group received routine guidance from the service plus the teaching program. The control group only received routine guidance from the service. The data collection instruments were: sociodemographic and clinical questionnaire, self-efficacy scale, hospital depression and anxiety scale, household care knowledge questionnaire, and an item on satisfaction with a score of 1 to 5. Results: There was a significant difference between the intragroups for satisfaction (p<0.001) and knowledge (p<0.001) of the pre-test to the post-test. In the intervention group, there were significant changes between the times for anxiety (p=0.011) and knowledge (p<0.001). Conclusion: The teaching program with a combination of oral guidance, written instruction and telephone follow-up was effective in improving knowledge about home care and personal satisfaction. Brazilian Registry of Clinical Trials: RBR-5n95rm.

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Effectiveness of cyproheptadine in the prevention of childhood migraine

Paediatrica Indonesiana ◽

10.14238/pi49.5.2009.286-91 ◽

2009 ◽

Vol 49 (5) ◽

pp. 286

Author(s):

Zulkarnain Zulkarnain ◽

Johannes Saing ◽

Yazid Dimyati ◽

Bistok Saing

Keyword(s):

Clinical Trial ◽

Prophylactic Treatment ◽

Functional Disability ◽

International Headache Society ◽

Controlled Clinical Trial ◽

Headache Frequency ◽

Disability Assessment ◽

Childhood Migraine ◽

Pediatric Migraine ◽

Significant Difference

Background Migraine is one of the causes of recurrent headachein childhood. Cyproheptadine is well known as an antihistamine,but there are few studies revealing the drug's effect in pediatricmigraine.Objective To determine the effectiveness of cyproheptadine in the prophylactic treatment of childhood migraine.Methods A randomized placebo-controlled clinical trial studywas performed at Medan. One hundred children with migraineaccording to the International Headache Society criteria wereincluded in the study. Subjects were divided into two groups, andeach group was given either 4 mg cyproheptadine or placebo for 12 weeks. Headache frequency was measured in headache days per month, duration was measured in hours and functional disability was measured by Pediatric Migraine Disability Assessment (PedMID AS). The efficacy was measured before intervention; also 1, 2, and 3 months after intervention.Results A total of 100 patients, with age ranging from 11 to 18 years old (with mean, 15.5 years), were treated with cyproheptadine or placebo for headache. Compared to baseline, there was a significant difference on PedMIDAS grading of migraines in both groups (P<0.05). Headache frequency and duration per month were significantly different after treatment with cyproheptadine (P=0.009, 95% CI 0.001 to 0.030 and P= 0.029, 95% CI 0.690 to 27.510, RR=4.36), compared to placebo group (P> 0.05), but there were side effects of cyproheptadine up to 73%.Conclusion Cyproheptadine appears to be effective as analternative prophylactic treatment of childhood migraine.However, pediatricians should consider the significant side effectsof this drug.

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Low Dose Perioperative Intravenous Tranexamic Acid in Patients Undergoing Total Knee Arthroplasty: A Double-Blind Randomized Placebo Controlled Clinical Trial

Journal of Blood Transfusion ◽

10.1155/2015/948304 ◽

2015 ◽

Vol 2015 ◽

pp. 1-5 ◽

Cited By ~ 3

Author(s):

Mahdi Motififard ◽

Mohammad Ali Tahririan ◽

Mehdi Saneie ◽

Sajad Badiei ◽

Amin Nemati

Keyword(s):

Tranexamic Acid ◽

Primary Outcome ◽

Low Dose ◽

Study Groups ◽

Controlled Clinical Trial ◽

Double Blind ◽

Significant Difference ◽

Duration Of Hospitalization ◽

Slow Infusion ◽

The Difference

Background and Objectives. The null hypothesis of this study was that TA has no effect on postsurgical bleeding in patients undergoing TKA. Methods. This study was a double-blind randomized trial. In the first group (T) patients received 500 mg of intravenous Tranexamic acid (TA) twice (once preoperatively and once 3 hours postoperatively) and in the second group (P) they received slow infusion of normal saline as placebo. The primary outcome of the study was the level of Hb 48 hours after surgery. Results. Hb levels 48 hours after surgery as the primary outcome were 10.92±0.97 and 10.23±0.98 (g/dL) in groups T and P, respectively, and the difference was statistically significant (P=0.001). Statistically significant differences were also observed in Hb levels 6 and 24 hours after surgery, the drain output 48 hours after surgery, and the number of units of packed cells transfused between study groups (P<0.05). There was no significant difference in duration of hospitalization between the study groups (P = n.s.). Conclusions. The low dose perioperative intravenous TA significantly reduces blood loss, requirement for blood transfusion, and drain output in patients undergoing TKA. However, duration of hospitalization did not change significantly.

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