scholarly journals A clinical efficacy of 30% ethenolic extract of Indian propolis and Recaldent TM in management of dentinal hypersensitivity: A comparative randomized clinical trial

2013 ◽  
Vol 07 (04) ◽  
pp. 461-468 ◽  
Author(s):  
Nilesh Arjun Torwane ◽  
Sudhir Hongal ◽  
Pankaj Goel ◽  
B. R. Chandrashekar ◽  
Manish Jain ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Rating Scale ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Sterile Water ◽  
Double Blind ◽  
Treatment Groups ◽  
Casein Phosphopeptide ◽  
Group B ◽  
Dentinal Hypersensitivity

ABSTRACT Objective: The aim of this study is to evaluate the efficacy of 30% ethenolic extract of Indian propolis compared with Recaldent TM (casein phosphopeptide-amorphous calcium phosphate) in reduction of dentinals hypersensitivity, a randomized, double-blind, split mouth, controlled clinical trial was conducted among the patients residing in Central Jail. Materials and Methods: A sample of 73 teeth from 13 patients having at least three teeth with dentinal hypersensitivity (DH) were randomly allocated into three treatment groups: Group A: 30% ethenolic extract of Indian propolis, Group B: Recaldent TM , Group C: Sterile water. Verbal rating scale was used to record the degree of hypersensitivity based on patient′s response to tactile and air blast stimuli. The baseline scores were obtained. Each intervention group received applications of their respective agents consecutively on 1 st , 7 th , 14 th , and 21 st day. After each application the scores were recorded. Results: Both the 30% Indian propolis and Recaldent TM showed significant reduction in DH. Conclusions: Recaldent TM was found to be significantly better in reducing the DH compared to propolis and sterile water (P < 0.01).

Adjunctive Therapy to Manage Neuropsychiatric Symptoms in Moderate and Severe Dementia: Randomized Clinical Trial Using an Outpatient Version of Tailored Activity Program

2021 ◽  
pp. 1-12
Author(s):  
Alexandra Martini Oliveira ◽  
Marcia Radanovic ◽  
Patricia Cotting Homem de Mello ◽  
Patricia Cardoso Buchain ◽  
Adriana Dias Barbosa Vizzotto ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sleep Disturbances ◽  
Rating Scale ◽  
Neuropsychiatric Symptoms ◽  
Caregiver Training ◽  
Controlled Clinical Trial ◽  
Post Intervention ◽  
Double Blind ◽  
Activity Program ◽  
Experimental Group

Background: Neuropsychiatric symptoms (NPS) such as aggression, apathy, agitation, and wandering may occur in up to 90%of dementia cases. International guidelines have suggested that non-pharmacological interventions are as effective as pharmacological treatments, however without the side effects and risks of medications. An occupational therapy method, called Tailored Activity Program (TAP), was developed with the objective to treat NPS in the elderly with dementia and has been shown to be effective. Objective: Evaluate the efficacy of the TAP method (outpatient version) in the treatment of NPS in individuals with dementia and in the burden reduction of their caregivers. Methods: This is a randomized, double-blind, controlled clinical trial for the treatment of NPS in dementia. Outcome measures consisted of assessing the NPS of individuals with dementia, through the Neuropsychiatric Inventory-Clinician rating scale (NPI-C), and assessing the burden on their caregivers, using the Zarit Scale. All the participants were evaluated pre-and post-intervention. Results: 54 individuals with dementia and caregivers were allocated to the experimental (n = 28) and control (n = 26) groups. There was improvement of the following NPS in the experimental group: delusions, agitation, aggressiveness, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, and aberrant vocalization. No improvement was observed in hallucinations, sleep disturbances, and appetite disorders. The TAP method for outpatient settings was also clinically effective in reducing burden between caregivers of the experimental group. Conclusion: The use of personalized prescribed activities, coupled with the caregiver training, may be a clinically effective approach to reduce NPS and caregiver burden of individuals with dementia.

scholarly journals Responsiveness of the Scripps Neurologic Rating Scale During a Multiple Sclerosis Clinical Trial

1999 ◽  
Vol 26 (4) ◽  
pp. 283-289 ◽  
Author(s):  
James A. Koziol ◽  
Adriana Lucero ◽  
Jack C. Sipe ◽  
John S. Romine ◽  
Ernest Beutler
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Rating Scale ◽  
Effect Sizes ◽  
Active Therapy ◽  
Double Blind ◽  
Treatment Groups ◽  
Negative Effect ◽  
The Individual ◽  
Positive Effect

Objective:The Scripps neurologic rating scale (SNRS) is a summary measure of individual components comprising a neurological examination, designed for use in multiple sclerosis (MS). Our objective is to evaluate the responsiveness of the SNRS, within the context of a 2-year, randomized, double-blind crossover study of the efficacy of cladribine for treatment of secondary progressive MS.Methods:Effect sizes were determined for the SNRS and its components, separately for each treatment group (initial placebo, and initial cladribine) over both years of the clinical trial, using a standard random effects model.Results:Individual components tended to show positive effect sizes (improvement) during periods of active therapy in both treatment groups, and negative effect sizes (deterioration) during periods of no active therapy. Summation indices derived from the individual components of the SNRS seemed somewhat more stable than the individual components. The two components mentation and mood, and bladder, bowel, or sexual dysfunction, were rather unresponsive in our clinical trial.Conclusion:Changes in the components of the SNRS over the course of our clinical trial were consistent between the two treatment groups. Most components were moderately responsive; and, the summary SNRS score appropriately summarized the moderate magnitudes of change evinced in the individual components.

scholarly journals Efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia: a protocol for randomised double-blind controlled clinical trial

BMJ Open ◽  
2020 ◽  
Vol 10 (10) ◽  
pp. e041958
Author(s):  
Nirmani Yasara ◽  
Nethmi Wickramarathne ◽  
Chamila Mettananda ◽  
Aresha Manamperi ◽  
Anuja Premawardhena ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sri Lanka ◽  
Intervention Group ◽  
Primary Outcome Measure ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Scientific Publications ◽  
Double Blind ◽  
Fetal Haemoglobin

IntroductionDespite being one of the first diseases to be genetically characterised, β-thalassaemia remains a disorder without a cure in a majority of patients. Most patients with β-thalassaemia receive only supportive treatment and therefore have a poor quality of life and shorter life spans. Hydroxyurea, which has shown to induce fetal haemoglobin synthesis in human erythroid cells, is currently recommended for the treatment of sickle cell disease. However, its clinical usefulness in transfusion-dependent β-thalassaemia is unclear. Here, we present a protocol for a randomised double-blind controlled clinical trial to evaluate the efficacy and safety of oral hydroxyurea in transfusion-dependent β-thalassaemia.Methods and analysisThis single-centre randomised double-blind placebo-controlled clinical trial is conducted at the Thalassaemia Centre of Colombo North Teaching Hospital, Ragama, Sri Lanka. Adult and adolescent patients with haematologically and genetically confirmed transfusion-dependent β-thalassaemia are enrolled and randomised into the intervention or control group. The intervention group receives oral hydroxyurea 10–20 mg/kg daily for 6 months, while the control group receives a placebo which is identical in size, shape and colour to hydroxyurea without its active ingredient. Transfused blood volume, pretransfusion haemoglobin level, fetal haemoglobin percentage and adverse effects of treatment are monitored during treatment and 6 months post-treatment. Cessation or reduction of blood transfusions during the treatment period will be the primary outcome measure. The statistical analysis will be based on intention to treat.Ethics and disseminationEthical approval has been obtained from the Ethics Committee of Faculty of Medicine, University of Kelaniya (P/116/05/2018) and the trial is approved by the National Medicinal Regulatory Authority of Sri Lanka. Results of the trial will be disseminated in scientific publications in reputed journals.Trial registration numberSLCTR/2018/024; Pre-results.

scholarly journals Pramipexole in peritoneal dialysis patients with restless legs syndrome (RLS): a protocol for a multicentre double-blind randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e033815
Author(s):  
Tian-tian Ma ◽  
Zhikai Yang ◽  
Sainan Zhu ◽  
Jing-hong Zhao ◽  
Yi Li ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Peritoneal Dialysis ◽  
Restless Legs Syndrome ◽  
Rating Scale ◽  
Controlled Trial ◽  
Psychological Status ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Restless Legs ◽  
Peking University

IntroductionRestless legs syndrome (RLS) is a common neurological sensorimotor disorder among patients with end stage renal disease. This clinical trial aimed to provide evidence on the efficacy and safety of pramipexole in patients with uremic RLS receiving peritoneal dialysis (PD).Methods and analysisThis is a 12-week, multicentre, randomised, double-blind, placebo-controlled clinical trial. In total, 104 patients with uremic RLS receiving PD will be enrolled from four hospitals and randomly assigned in a 1:1 ratio to either placebo or pramipexole. We will determine the efficacy of pramipexole in the improvement of International RLS Study Group Rating Scale as the primary outcome, while responder rates for other RLS scales at week 12, change from baseline to week 12 for psychological status, sleep disorder and quality of life and blood pressure represent the secondary outcomes.Ethics and disseminationThe study was approved by the ethics committees of Peking University First Hospital, Xinqiao hospital of Army Medical University, Cangzhou Center Hospital and Peking University Shenzhen Hospital. The results will be disseminated in peer-reviewed journals.Trial registration numberNCT03817554

OscillococcinumR in patients with influenza-like syndromes: A placebo-controlled double-blind evaluation

1998 ◽  
Vol 87 (02) ◽  
pp. 69-76 ◽  
Author(s):  
Rosemarie Papp ◽  
Gert Schuback ◽  
Elmar Beck ◽  
Georg Burkard ◽  
Jürgen Bengel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Rectal Temperature ◽  
Muscle Pain ◽  
Rating Scale ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Duration Of Symptoms ◽  
Number Of Patients ◽  
Positive Effect

AbstractA controlled clinical trial was conducted to assess the effectiveness of OscillococcinumR in the treatment of patients with influenza-like syndromes. 188 patients received the test drug and 184 patients were assigned to the placebo. Data were recorded by the participating physicians at the beginning of the treatment, after 48 hours and after 7–10 days. During the first few days, the patients recorded their rectal temperature twice a day (mornings and evenings), 9 symptoms on a rating scale (cough, catarrh, sore throat, muscle pain, etc.), and use of medication. Recovery was defined as follows: ‘rectal temperature < 37.5°C and no headache or muscle pain’. Effectiveness was defined as a statistically significant greater decrease in symptoms after 48 hours in the verum group or a shorter duration of symptoms in comparison to the placebo group. After 48 hours the symptoms of the patients in the verum group were significantly milder (P=0.023) than in the placebo group. The number of patients with no symptoms was significantly higher in the verum group from the second day onwards (verum: 17.4%, placebo: 6.6%) until the end of the patients’ recording (day 5 in the evening: verum: 73.7%, placebo: 67.7%). The biggest group difference was recorded for the time between the evening of the second day (10.6% more patients with no symptoms) and the morning of the fourth day (10.2% more patients with no symptoms). The clinical trial showed that treatment of influenza-like syndromes with OscillococcinumR has a positive effect on the decline of symptoms and on the duration of the disease.

scholarly journals Impact of vitamin A supplementation in anaemia during pregnancy: a randomized double blind controlled clinical trial

2018 ◽  
Vol 7 (6) ◽  
pp. 2262
Author(s):  
Shakun Singh ◽  
Rachna Chaudhary ◽  
Vandana Dhama ◽  
Anu Singh ◽  
Urmila Karya
Keyword(s):  
Clinical Trial ◽  
Vitamin A ◽  
Pregnant Women ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Vitamin A Supplementation ◽  
Elemental Iron ◽  
Group A ◽  
Group B ◽  
The Impact

Background: To study the impact of Vitamin A supplementation in anaemia during Pregnancy and thus improving maternal and fetal outcome a Randomized double blind controlled clinical trial was conducted in Department of Obstetrics and Gynaecology, L.L.R.M. Medical college Meerut involving 250 pregnant women in late pregnancy 18-28 weeks with haemoglobin levels <11 g% (7-11 g%)..Methods: The study subjects were divided into two groups: Group A (n=125): Received daily supplement containing Iron (60 mg elemental iron) + Folate (500 mcg) + Vitamin A 20,000 IU weekly for a minimum of 12 weeks. Group B (n=125): Received daily supplement containing iron (60 mg elemental iron) + Folate (500 mcg) for a minimum of 12 weeks.Results: Maximum patients were uneducated belonging to low socioeconomic status. The mean haemoglobin values in Group A and Group B increased from 9.674±1.05 and 9.53±1.04 to 12.2±0.89 and 10.82±1.06 respectively after supplementation. Similarily Serum Ferritin levels increased from 15.96±2.94 and 15.70±2.83 to 78.40±17.82 and 58.64±11.93. Mean corpuscular volume, packed cell volume and red blood cell counts also increased significantly. Maximum haemoglobin levels were achieved with both vitamin A and iron supplementation. The proportion of women who became non anaemic was 97.17% in Group A vs 68.69% in Group B.Conclusions: Vitamin A supplementation improves anaemia and also dramatically improves iron stores in anaemic pregnant women.

Effects of Helichrysum Psudoplicatum supplementation on pruritus intensity, fatigue, quality of life and anorexia in hemodialysis patients: a randomized, double-blind placebo-controlled trial

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Maryam Mohajeranirad ◽  
Naser Saeidi ◽  
Mohammad Kamali Nejad ◽  
Amir Almasi-Hashiani ◽  
Mehdi Salehi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Rating Scale ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Dialysis Patients ◽  
Time Duration ◽  
Double Blind ◽  
Double Blind Placebo

Abstract Objectives Anorexia, fatigue and pruritus are common complications of hemodialysis (HD) patients. Today, the use of medicinal plants is more than synthetic drugs due to their safety. Therefore, we designed a randomized controlled clinical trial to evaluate the effects of Helichrysum psudoplicatum (H. psudoplicatum) supplementation on biochemical parameters, pruritus intensity, fatigue, quality of life and anorexia in HD patients. Methods This randomized, double-blind, placebo-controlled trial was performed on 50 subjects with, aged 55–65 years old. HD patients were randomly divided into two groups. Intervention group received 250 mg/day of H. psudoplicatum supplement capsule for 6 weeks (n=25), and the placebo group was given placebo capsule for the same time duration and dosage (n=25). The serum concentrations of urea, creatinine, albumin and hemoglobin were measured enzymatically methods. Anorexia, pruritus intensity, quality of life the dialysis patients with pruritus and fatigue score was measured using a Simplified Nutritional Appetite Questionnaire (SNAQ), Numerical rating scale (NRS), Fatigue severity scale (FSS) and ItchyQoL questionnaire, respectively. Shapiro–Wilk and independent-samples t-test or Mann–Whitney test were used for the analysis of the data. Results The results showed that the H. psudoplicatum supplementation significantly improved the pruritus intensity, quality of life the dialysis patients with pruritus and fatigue in HD patients, for 6 weeks (p<0.001). However, it did not significantly effect on the anorexia, albumin, hemoglobin, urea, creatinine, arm circumference, and body mass index (p>0.05). Conclusions According to the results of this study, H. psudoplicatum supplementation can be effective as an adjunct therapy to improve pruritus intensity, quality of life, fatigue and relative improvement of anorexia in HD patients.

scholarly journals Rhodomyrtone as a New Natural Antibiotic Isolated from Rhodomyrtus tomentosa Leaf Extract: A Clinical Application in the Management of Acne Vulgaris

Antibiotics ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. 108
Author(s):  
Suttiwan Wunnoo ◽  
Siwaporn Bilhman ◽  
Thanaporn Amnuaikit ◽  
Julalak C. Ontong ◽  
Sudarshan Singh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Clinical Assessment ◽  
Leaf Extract ◽  
Acne Vulgaris ◽  
Treated Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Treatment Groups ◽  
Rhodomyrtus Tomentosa

Rhodomyrtone, a plant-derived principal compound isolated from Rhodomyrtus tomentosa (Myrtaceae) leaf extract, was assessed as a potential natural alternative for the treatment of acne vulgaris. The clinical efficacy of a 1% liposomal encapsulated rhodomyrtone serum was compared with a marketed 1% clindamycin gel. In a randomized and double-blind controlled clinical trial, 60 volunteers with mild to moderate acne severity were assigned to two groups: rhodomyrtone serum and clindamycin gel. The volunteers were instructed to apply the samples to acne lesions on their faces twice daily. A significant reduction in the total numbers of acne lesions was demonstrated in both treatment groups between week 2 and 8 (p < 0.05). Significant differences in acne numbers compared with the baseline were evidenced at week 2 onwards (p < 0.05). At the end of the clinical trial, the total inflamed acne counts in the 1% rhodomyrtone serum group were significantly reduced by 36.36%, comparable to 34.70% in the clindamycin-treated group (p < 0.05). Furthermore, a commercial prototype was developed, and a clinical assessment of 45 volunteers was performed. After application of the commercial prototype for 1 week, 68.89% and 28.89% of volunteers demonstrated complete and improved inflammatory acne, respectively. All of the subjects presented no signs of irritation or side effects during the treatment. Most of the volunteers (71.11%) indicated that they were very satisfied. Rhodomyrtone serum was demonstrated to be effective and safe for the treatment of inflammatory acne lesions.

scholarly journals The effect of Melissa officinalis syrup on patients with mild to moderate psoriasis: a randomized, double-blind placebo-controlled clinical trial

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Alireza Yargholi ◽  
Leila Shirbeigi ◽  
Roja Rahimi ◽  
Parvin Mansouri ◽  
Mohammad Hossein Ayati
Keyword(s):  
Clinical Trial ◽  
Intervention Group ◽  
Herbal Medicines ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Skin Area ◽  
Melissa Officinalis ◽  
Double Blind ◽  
Significant Difference ◽  
Pre Treatment

Abstract Objective Psoriasis is an immune-mediated inflammatory skin disease. It can involve any body skin area, particularly the scalp, lower back, elbows, and knees. There are several topical and systemic therapies for the treatment. Nowadays, herbal medicines are popular treatments for dermatologic conditions. This two-arm parallel, randomized placebo-controlled clinical trial was conducted to examine the hypothesis of the efficacy of Melissa officinalis syrup on patients with mild-to-moderate Plaque psoriasis. Result Among 100 patients, 95 participants completed the trial and five of them withdrew. The mean pruritus intensity and PASI scores decreased significantly in the intervention group compared to the placebo group (P < 0.001). The DLQI score in the intervention group increased post-treatment compared to pre-treatment (P = 0.029); however, there was no significant difference between the intervention and control group at the end of the study (0.065). Trial registration: The trial was registered in the Iranian registry of clinical trials on November 9th, 2019 (https://www.irct.ir/trial/43434; registration number: IRCT20191104045326N1).

scholarly journals Does synbiotic supplementation affect the quality of life in children with cystic fibrosis? A pilot randomized controlled clinical trial

2020 ◽  
Author(s):  
Nemat Bilan ◽  
Effat Marefat ◽  
Leila Nikniaz ◽  
Mahdieh Abbasalizad Farhangi ◽  
Zeinab Nikniaz
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Demographic Data ◽  
Intervention Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
The Mean ◽  
Synbiotic Supplementation

Abstract Background: There is no clinical trial that assesses the effect synbiotic supplementation on HRQOL in CF children. Considering the importance of HRQOL as an essential primary outcome and determinant of therapeutic benefit in chronic diseases like cystic fibrosis, the present clinical trial aimed to determine the efficacy of synbiotic supplementation on HRQOL in children with CF.Methods: In the present double-blind randomized clinical trial, 40 CF children were randomly allocated to the two groups. The intervention group was supplemented with synbiotics supplements and the patients in the placebo group received maltodextrin for six months. Demographic data and information about antibiotic use were recorded using the questionnaire. The health-related quality of life was assessed using the Persian version of quality of life inventory questionnaires. Paired t-test and ANCOVA were used for statistical analysis. Results: Totally, 36 participants completed the trial. The mean score of HRQOL was 76.34±17.33. There were no significant differences between synbiotic and placebo groups regarding baseline demographic and quality of life characteristics. Compared with baseline values, the mean total score and subscores of quality of life did not change significantly after synbiotic and placebo supplementation (p>0.05). Moreover, the results of ANCOVA showed that there were no significant differences between the two groups regarding the post-trial value of HRQOL total score and subscores. Conclusion: According to results, six-month supplementation with synbiotic did not have a significant effect on the HRQOL in children with CF. However, further studies with larger sample sizes and using more disease-specific questionnaires are needed for a more precise conclusion. The protocol of the study was registered at Iranian registry clinical trials (Registration code: IRCT2017011732004N1; Registration date: 2017-02-14).

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