scholarly journals High efficacy of a dimeticone-based pediculicide following a brief application: in vitro assays and randomized controlled investigator-blinded clinical trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Jorg Heukelbach ◽  
Doerte Wolf ◽  
John Marshall Clark ◽  
Hans Dautel ◽  
Kristina Roeschmann
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
Head Lice ◽  
Ovicidal Activity ◽  
Vitro Assay ◽  
Test Product ◽  
Randomized Controlled ◽  
Development Of Resistance ◽  
Reduced Risk

Abstract Background Increasing resistance of head lice against neurotoxic agents and safety concerns have led to the search for treatment alternatives. Dimeticones with a physical mode of action are safe, and bear a reduced risk for the development of resistance. Methods We performed in vitro bioassays to assess pediculicidal and ovicidal activities of a new dimeticone-based product, and a randomized controlled clinical trial to assess efficacy, following 10 min application. Of 153 individuals screened, 100 participants with active head louse infestations were randomly assigned to treatment with either a dimeticone-based test product, or a 0.5% permethrin-based reference product (50 participants per group). Participants received two topical applications of either the test (10 min) or reference products (45 min) at days 0 and 7 or 8. Outcome measures included the efficacies of treatment and their safety, as well as global and local tolerability at baseline, and days 1, 7, and 10. Results After 10 min exposure, all lice treated with the dimeticone test product were classified as non-viable in the in vitro assay. Ovicidal activity after treatment of eggs with the dimeticone test product was 96.8%. In the clinical trial, 96 patients completed all study visits. In the full analysis set (FAS) population, on day 1 after one application, 98% of patients were cured in the test group, as compared to 84% cured in the reference group. All participants in both groups were free of head lice on day 10, following two applications (100% cure rate). In total, 42 adverse events (AEs) in 23 patients of both treatment groups were recorded, with the majority of AEs classified as mild. Conclusions We have shown a high level of pediculicidal and ovicidal activity, and clinical efficacy and safety, of a brief application of a new dimeticone-based product. The short application time and reduced risk for the development of resistance are key drivers for improved patients’ compliance. Trial registration EU Clinical Trials Register EudraCT 2016–004635-20. Registered 14 November 2016.

scholarly journals Supragingival plaque removal with and without dentifrice: a randomized controlled clinical trial

2012 ◽  
Vol 23 (3) ◽  
pp. 235-240 ◽  
Author(s):  
Fabricio B. Zanatta ◽  
Raquel P. Antoniazzi ◽  
Tatiana M. P. Pinto ◽  
Cassiano K. Rösing
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Separate Analysis ◽  
Randomized Controlled Clinical Trial ◽  
Significance Level ◽  
Plaque Removal ◽  
Randomized Controlled ◽  
Removal Capacity

The aim of this study was to compare the efficacy of dental plaque removal by brushing with and without conventional dentifrice. Twenty-four students aged 17 to 28 years participated in this randomized controlled clinical trial. Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 h of cessation of oral hygiene, Quigley & Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by Student's paired sample t-test at 5% significance level. The results showed that both groups after toothbrushing presented statistically significant reductions in plaque, with no differences between them (from 3.06 ± 0.54 to 1.27 ± 0.26 versus from 3.07 ± 0.52 to 1.31 ± 0.23). A separate analysis of the buccal and lingual aspects also showed no significant differences between groups. It may be concluded that the use of a conventional dentifrice during toothbrushing does not seem to enhance plaque removal capacity.

scholarly journals Anti-Inflammatory Potential of Complex Extracts of Ligularia stenocephala Matsum. & Koidz. and Secale cereale L. Sprout in Chronic Gingivitis: In Vitro Investigation and Randomized Clinical Trial

Antioxidants ◽  
2021 ◽  
Vol 10 (10) ◽  
pp. 1586
Author(s):  
Inpyo Hong ◽  
Jin-Young Park ◽  
Yoo-Hun Noh ◽  
Su-Hee Jeon ◽  
Jeong-Won Paik ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cell Viability ◽  
Secale Cereale ◽  
Test Group ◽  
Number Of Patients ◽  
In Vitro Investigation ◽  
Secale Cereale L ◽  
Anti Inflammatory ◽  
Ligularia Stenocephala

Complex extracts of Ligularia stenocephala Matsum. & Koidz. (LSE) and Secale cereale L. sprout (SCSE) (TEES-10®) were prepared. The purposes of the study were to evaluate anti-inflammatory activities of TEES-10® in vitro and to observe resolution of gingivitis in human with oral administration of TEES-10®. The effects of TEES-10® on normal periodontal ligament (PDL) cell viability, lipopolysaccharide (LPS) induced PDL cell viability and the changes of inflammatory mediator expression were evaluated in vitro. In the clinical trial, 150 mg of TEES-10® powder containing capsule was administered twice daily to the test group, while the control group administered placebos in a total 100 participants with gingivitis. Probing depth (PD), bleeding on probing (BOP), clinical attachment loss, gingival index (GI) and plaque index (PI) were measured at baseline and 4 weeks. Administering TEES-10® showed significant increase in PDL cell viability compared to administering LSE or SCSE alone. In addition, treating TEES-10® to LPS induced PDL cell significantly increased PDL cell viability compared to control. TEES-10® suppressed expression of NF-κB, p-ERK, ERK, COX-2, c-Fos and p-STAT and promoted expression of PPARγ in LPS induced PDL cells. In the clinical trial, significant improvement of GI and BOP was observed in the test group at 4 weeks. In addition, the number of patients diagnosed with gingivitis was significantly reduced in the test group at 4 weeks. Salivary MMP-8 and MMP-9 was also significantly decreased compared to placebo group. Within the limitations of this study, the TEES-10® would have an anti-inflammatory potential clinically in the chronic gingivitis patients.

scholarly journals Healing of intrabony defects following regenerative surgery by means of single-flap approach in conjunction with either hyaluronic acid or an enamel matrix derivative: a 24-month randomized controlled clinical trial

2021 ◽  
Author(s):  
Andrea Pilloni ◽  
Mariana A. Rojas ◽  
Lorenzo Marini ◽  
Paola Russo ◽  
Yoshinori Shirakata ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Test Group ◽  
Enamel Matrix Derivative ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Enamel Matrix ◽  
Randomized Controlled Clinical Trial ◽  
Intrabony Defects ◽  
Randomized Controlled ◽  
Matrix Derivative

Abstract Objectives The aim of this randomized controlled clinical trial was to compare the clinical outcomes obtained in intrabony defects following regenerative periodontal surgery using the single-flap approach (SFA) in conjunction with either hyaluronic acid (HA) or enamel matrix derivative (EMD). Materials and methods Thirty-two intrabony defects in 32 healthy subjects were randomly assigned: HA (test group) or EMD (control group). Clinical attachment level (CAL), probing depth (PD), gingival recession (REC), and bleeding on probing (BOP) were recorded at baseline,12, 18, and 24 months after surgery. Results At 24 months, both treatments resulted in statistically significant clinical improvements evidenced by PD-reduction and CAL-gain (p<0.001). The mean CAL-gain was 2.19±1.11 mm in the test and 2.94±1.12 mm in the control sites (p=0.067). PD-reduction was statistically significantly higher for the control group (4.5±0.97 mm) than the test group (3.31±0.70 mm), (p=0.001). CAL-gain ≤ 3 mm was observed in 87.5% and in 62.5% of the test and control sites, respectively. Test sites showed slightly lower REC values than the control sites. No statistically significant differences were found for BOP between treatments. Conclusions The present findings indicate that both treatments led to statistically significant clinical improvements compared to baseline, although the application of EMD resulted in statistically significantly higher PD-reduction compared to the use of HA. Clinical relevance The use of HA in conjunction with a SFA resulted in significant PD-reduction and CAL-gain, pointing to the potential clinical relevance of this material in regenerative periodontal surgery.

Efficacy and Safety of Hydroxychloroquine Sulphate In Chronic Lymphocytic Leukemia: Clinical Trial Experience In Untreated Patients

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 1392-1392
Author(s):  
Shih-Shih Chen ◽  
Matthew Kaufman ◽  
Angelica Caramanica ◽  
Rajendra N Damle ◽  
Peter Garofalo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Cell Proliferation ◽  
Disease Progression ◽  
Repeated Measures ◽  
Conflicts Of Interest ◽  
Lymphocytic Leukemia ◽  
Vitro Assay ◽  
Blood Concentrations ◽  
Absolute Lymphocyte Counts

Abstract Abstract 1392 Background: Hydroxychloroquine (HCQ) has been used safely for many years for treatment of malaria, systemic lupus erythematosus and rheumatoid arthritis. It is known to have exerted immunomodulatory actions by affecting antigen presentation by macrophages and dendritic cells, DNA/RNA synthesis, and apoptosis in lymphocytes and endothelial cells. All of these actions can be attributed at least partially to the inactivation of endosomal acid proteases. CLL is the abnormal proliferation of a B lymphocyte clone. Based on the unique structural characteristics of the B-cell antigen receptor (BCR), at least some CLL cases probably results from ongoing antigen selection and stimulation. RNA and/or DNA from infection or cell apoptosis are candidate stimulants of this process. Binding of RNA and DNA to toll-like receptors (TLR 7 and 9) in endosomes is dependent on an acidic pH and can be prevented by HCQ due to its de-acidifiying effect. HCQ can also directly induce apoptosis in CLL cells through caspase 3 activation in vitro. We therefore hypothesized that administration of HCQ early in the disease would protect CLL patients from disease progression by eliminating these stimulatory TLR 7 and 9 signals. Methods: 22 CLL patients with no urgent need for treatment were enrolled in the clinical trial. Patients took HCQ 400 mg/day for 52 weeks. Clinical response was measured every 4 weeks by history, physical exam, and absolute lymphocyte counts. Additional blood samples were taken every 8 weeks for companion laboratory studies. Statistical analyses used include Fisher's Exact Test, Slopes analysis and Repeated measures analysis of variance on the log-transformed absolute lymphocyte counts (ALCs). Results: In total, 8 IGHV unmutated (U-CLL) and 14 mutated (M-CLL) patients were enrolled; 3 U-CLL and 10 M-CLL completed the full year of HCQ treatment. Five U-CLL patients were dropped from the study due to disease progression requiring CLL therapy. One M-CLL patient left for personal reasons. Three M-CLL patients are still continuing on HCQ therapy. Patient outcomes can be separated into three patterns based on ALC changes: 7 patients (6 M-CLL and 1 U-CLL) had stable counts throughout the trial; 12 patients (8 M-CLL and 4 U-CLL) had a fall in ALCs after treatment; and 3 patients (all U-CLL) developed increased ALCs. The response to HCQ in CLL is associated with Ig V mutation status of patients (P<.03). With some U-CLL patients having a worsening of disease; overall U-CLL patients have worse outcome than M-CLL (P<.045). Nevertheless in most instances, U-CLL patients did respond to HCQ with stabilization or fall in ALC initially, although this was followed at an average of 18–22 weeks with an increase in ALCs and in some instances a need for therapy. Maximum HCQ blood concentrations in healthy individuals receiving 400 mg/day HCQ orally are reported to range from 67–221 ng/ml. In vitro assay using samples collected at trial initiation indicated that direct CLL cytotoxicity occurred at levels ≥10 μg/ml; this value was similar for U- and M-CLL clones. Using a non-cytotoxic concentration of 1 μg/ml of HCQ, in vitro TLR9 ligand ODN2006 enhanced expression of TLR9 was diminished. The proliferation and activation of both U- and M-CLL was blocked completely, although concentrations of 10–100 ng/ml had a superior blocking effect on M-CLL than U-CLL clones. In vivo administration of HCQ blocked CLL cell proliferation initiated by ODN2006. In comparison with samples taken before HCQ administration, patient samples obtained after trial initiation responded to ODN2006 poorly. Interestingly, the type of CLL cell response to ODN2006 closely correlated with patient's ALC change. The least blocking of HCQ on cell proliferation was again observed in U-CLL patients, especially with the samples taken from the timepoint at which elevated ALCs were observed. Conclusion: In this clinical trial, oral administration of HCQ (400 mg/day) stabilized or decreased ALCs in the initial 18–22 weeks (of a 46–52 week regimen) in 91% of patients (14 M-CLL and 6-U-CLL). Subsequently, rising ALCs were observed in most of the U-CLL cases (n=4), and ALCs in M-CLL patients remain stabilized. Our in vitro evaluation suggests that an increased dose of HCQ might target TLR9 signaling better and thus improve outcome especially in U-CLL cases. Another possibility that warrants further study is that HCQ may have several actions on CLL cells leading to worse outcome of the disease. Disclosures: No relevant conflicts of interest to declare.

Effect of Arjun Chāl on cardiovascular risk factors – a randomized controlled clinical trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Saima Saleem ◽  
Abdul Haseeb Ansari ◽  
Aysha Ansari
Keyword(s):  
Risk Factors ◽  
Clinical Trial ◽  
Risk Factor ◽  
Cardiovascular Risk ◽  
Lipid Profile ◽  
Test Group ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Detailed Medical History

Abstract Objectives Cardiovascular diseases have a multifaceted, it causes modern epidemic; Recognizing in the risk factor stage, is crucial, given the risk of progression to cardiovascular disease. Ibn Sīnā, described CVDs as a resultant of gradual derangement of Quwwat ghādhiya (Nutritive faculty); in which management with ghidhā’ (diet), tadābīr (regimens), dawā’ (drug) has been received. To evaluate the effect of Arjun Chāl (Terminalia arjuna) in CVD risk factors. And to evaluate the drug safety. Methods This is a randomized controlled clinical trial. Total 120 patients were screened at OPD of NIUM hospital, Bangalore during 2018–19, only 48 patients fulfilled the inclusion criteria and signed written informed consent and their detailed medical history was recorded. Arjun Chāl powder (5 gm BD) for eight weeks administered in test group (n=24), Amlodipine (5 mg) and Atorvastatin (10 mg) once a day for same duration administered in control group (n=24). Efficacy of the drug assessed by the Lipid profile, BP and BMI; lipid profile were performed at baseline and at 8 weeks, while BP and BMI performed at baseline, 15, 30, 45, and 60th day intervals. Study was completed by 40 patients. The results of both the therapies were then compared and statistically analyzed. Results Totally, both groups reduces assessment parameters i.e. statistically highly significant (p<0.001). Test group showed greater reduction in terms of all assessment parmeters. But, the difference between both the groups was statistically non-significant p>0.05. Conclusions Both test and control drugs were effective, but Arjun Chāl had a slight edge over amlodipne and atorvastatin, and was found to be safe and well tolerated. It has a cardio protective potential and hence effective to delay/prevent CVD in patient with cardiovascular risk factor.Keywords: Unani System of Medicine; T. arjuna; Arjun Chāl; Efficacy; Safety; Cardiovascular risk factor.

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