scholarly journals Plant-Derived Lactobacillus paracasei IJH-SONE68 Improves Chronic Allergy Status: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Nutrients ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 4022
Author(s):  
Masafumi Noda ◽  
Keishi Kanno ◽  
Narandalai Danshiitsoodol ◽  
Fumiko Higashikawa ◽  
Masanori Sugiyama
Keyword(s):  
Clinical Trial ◽  
Intervention Group ◽  
Lactobacillus Paracasei ◽  
Controlled Clinical Trial ◽  
Experimental Diet ◽  
Self Assessment ◽  
Double Blind ◽  
Pineapple Juice ◽  
Males And Females ◽  
Spray Dried

We have recently demonstrated that the exopolysaccharides (EPSs) produced by a plant-derived lactic acid bacterium, Lactobacillus paracasei IJH-SONE68, prevent and ameliorate allergic reaction on contact in dermatitis model mice. In the present study, we conducted a clinical trial using a capsule containing spray-dried powder from pineapple juice broth fermented with the LAB strain as an experimental diet. The clinical trial was conducted as a double-blind and placebo-controlled randomized comparative study from May 2019 to July 2021. Males and females between the ages of 21 and 70 who experience chronic allergies participated in the study. Sixty subjects were instructed to orally take a capsule containing the IJH-SONE68 powder or placebo, every day for 12 weeks. After the clinical trial was over, the scores based on subjects’ self-assessment of allergic status were significantly improved in the intervention group, as compared with the placebo group. Some serum biochemicals associated with inflammation response were also significantly improved by intake of the experimental diet. In conclusion, the IJH-SONE68-derived EPS improves chronic allergy status in humans and is expected to decrease their inconvenience.

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 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).

The Preventive Effects of Boron-Based Gel on Radiation Dermatitis in Patients Being Treated for Breast Cancer: A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial

2022 ◽  
pp. 1-8
Author(s):  
Fikrettin Sahin ◽  
Mohammad Bagher Pirouzpanah ◽  
Hossein Bijanpour ◽  
Mohammad Mohammadzadeh ◽  
Reza Eghdam Zamiri ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Placebo Group ◽  
Intervention Group ◽  
Phase Iii ◽  
Radiation Dermatitis ◽  
Placebo Control ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Moist Desquamation

<b><i>Introduction:</i></b> Radiation dermatitis (RD) is a side effect of radiation therapy (RT) which is experienced by over 90% of patients being treated for breast cancer. The current clinical trial was conducted to measure the preventative effects of a boron-based gel on several different clinical outcomes (dermatitis, erythema, dry desquamation, and moist desquamation) after 25 radiotherapy sessions. <b><i>Methods:</i></b> This research used a double-blind parallel-group design with a placebo control (<i>n</i> = 76) and randomized group (<i>n</i> = 181), with all participants being between 18 and 75 years old. Fifteen minutes before each radiotherapy, participants in the intervention group were given a gel containing 3% sodium pentaborate pentahydrate, while those in the placebo group received a gel with no chemical substance. Dermatitis, erythema, dry desquamation, and moist desquamation were compared between the 2 groups. <b><i>Results:</i></b> At baseline, there were no significant differences between the groups (<i>p</i> &#x3e; 0.05), except for body mass index. After 14 days of treatment, dermatitis (98.7% vs. 9.9%; <i>p</i> &#x3c; 0.001), erythema (96.1% vs. 12.2%; <i>p</i> &#x3c; 0.001), dry desquamation (50% vs. 3.9%; <i>p</i> &#x3c; 0.001), and moist desquamation (18.4% vs. 0.6%; <i>p</i> &#x3c; 0.001) were much more common in the placebo group than the intervention group. To prevent dermatitis, erythema, dry desquamation, and moist desquamation in 1 patient, on average, 1.1 (95% confidence interval [CI]: 1.1–1.2), 1.2 (95% CI: 1.1–1.3), 2.2 (95% CI: 1.7–2.9), and 5.6 (95% CI: 3.8–11.0) patients need to be treated, respectively. <b><i>Conclusion:</i></b> The boron-based gel has a significant preventive effect on several categories of RD which might be used by clinicians in breast cancer.

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).

scholarly journals The effects of Berberis vulgaris consumption on plasma levels of IGF-1, IGFBPs, PPAR-γ and the expression of angiogenic genes in women with benign breast disease: a randomized controlled clinical trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Saeed Pirouzpanah ◽  
Sanaz Asemani ◽  
Ali Shayanfar ◽  
Behzad Baradaran ◽  
Vahid Montazeri
Keyword(s):  
Clinical Trial ◽  
Plasma Levels ◽  
Benign Breast Disease ◽  
Intervention Group ◽  
Breast Disease ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Igf Binding Proteins ◽  
Berberis Vulgaris ◽  
Ppar Γ

Abstract Background The present study was designed to investigate the effects of Berberis vulgaris (BV) juice consumption on plasma levels of insulin-like growth factor (IGF-1), IGF-binding proteins (IGFBPs), and the expression of PPAR-γ, VEGF and HIF in women with benign breast disease. Methods This parallel design randomized, double-blind controlled clinical trial was conducted on 85 eligible patients diagnosed with benign breast disease. They were assigned randomly into either BV juice group (n = 44, BV juice: 480 ml/day) or placebo group (n = 41, BV placebo juice: 480 ml/day) for 8 weeks intervention. Participants, caregivers and those who assessed laboratory analyses were blinded to the assignments. Plasma levels of biomarkers were measured at baseline and after 8 weeks by ELISA. Quantitative real-time PCR was used to measure the fold change in the expression of each interested gene. Results The compliance of participants was 95.2% and 40 available subjects analyzed in each group at last. Relative treatment (RT) effects for BV juice caused 16% fall in IGF-1 concentration and 37% reduction in the ratio of IGF-1/1GFBP1. Absolute treatment effect expressed 111 ng/ml increased mean differences of IGFBP-3 between BV group and placebo. Plasma level of PPAR-γ increased in both groups but it was not significant. Fold changes in the expressions of PPAR-γ, VEGF and HIF showed down-regulation in the intervention group compared to placebos (P < 0.05). Conclusions The BV juice intervention over 8 weeks was accompanied by acceptable efficacy and decreased plasma IGF-1, and IGF-1/IGFBP-1 ratio partly could be assigned to enhanced IGFBP-1 level in women with BBD. The intervention caused reductions in the expression levels of PPAR, VEGF, and HIF which are remarkable genomic changes to potentially prevent breast tumorigenesis. Trial registration IRCT2012110511335N2. Registered 10 July 2013 (retrospectively registered).

scholarly journals Efficacy of transdermal delivery of liposomal micronutrients through body oil massage on neurodevelopmental and micronutrient deficiency status in infants: results of a randomized placebo-controlled clinical trial

BMC Nutrition ◽  
2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Aditi Apte ◽  
Mudra Kapoor ◽  
Sadanand Naik ◽  
Himangi Lubree ◽  
Pooja Khamkar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Vitamin D ◽  
Placebo Group ◽  
Motor Development ◽  
Transferrin Saturation ◽  
Intervention Group ◽  
Micronutrient Deficiency ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Moderate Anemia

Abstract Background Micronutrient deficiency is a known cause of adverse neurodevelopment and growth. Poor adherence to oral regimes of micronutrient supplements is a known challenge during the implementation of supplementation programs. The present study evaluates the benefits of liposomal encapsulated micronutrient fortified body oils (LMF oil) that can be used for infant body massage in terms of neurodevelopment and prevention of deficiency. Study design Double-blind randomized clinical trial. Methods A total of 444 healthy infants aged 4-7 weeks were randomized to receive either LMF oil (containing iron, vitamin D, folate, and vitamin B12) or placebo oil for gentle body massage till 12 months of age. Blood samples were collected at 6 and 12 months for transferrin saturation (TSAT), hemoglobin, and 25-hydroxy vitamin (25-OH-D) levels. Mental and motor development was assessed at 12 months using developmental assessment for Indian Infants (DASII). Results A total of 391 infants completed the study. There was no significant improvement in the hemoglobin in the intervention group at 12 months of age as compared to the placebo group [− 0.50 vs.-0.54 g%]. There was a marginally significant improvement in 25-OH-D at 12 months in the LMF oil group [+ 1.46vs.-0.18 ng/ml, p = 0.049]. In the subgroup of infants with moderate anemia, the intervention prevented the decline in hemoglobin at 12 months of age [adjusted mean change + 0.11vs.-0.51 g%, p = 0.043]. The mental or motor developmental quotients in the intervention group were not significantly different from those in the placebo group. Conclusion Use of LMF oil for prevention of nutritional deficiency did not offer significant protection against nutritional anemia but prevented vitamin D deficiency to some extent with improvement in 25-OH-D at 12 months. In the subgroup of infants with moderate anemia, the intervention prevented the decline in hemoglobin at 12 months of age. The intervention did not result in significant improvement in mental or motor development. Further evaluation with increased doses needs to be undertaken. Trial registration CTRI no: CTRI/2017/11/010710; dated 30/11/2017.

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).

scholarly journals The Effect of a Persian Herbal Medicine Compound on the Lipid Profiles of Patients with Dyslipidemia: A Randomized Double-Blind Placebo-Controlled Clinical Trial

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Alireza Niknafs ◽  
Mohammadreza Rezvanfar ◽  
Mohammad Kamalinejad ◽  
Seyed Amirhosein Latifi ◽  
Amir Almasi-Hashiani ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Biochemical Parameters ◽  
Low Density Lipoprotein ◽  
Intervention Group ◽  
Density Lipoprotein ◽  
Serum Levels ◽  
Controlled Clinical Trial ◽  
Low Density ◽  
Double Blind ◽  
Herbal Compound

Introduction. It has been well established in the world that lipid disorders promote the development of atherosclerosis and its clinical consequences. This study aimed to assess the impacts of a Persian medicinal (PM) compound on lipid profile. Materials and Methods. From June 21 to October 21, 2020, a randomized double-blind controlled clinical trial was conducted with 74 dyslipidemic patients, who were randomly divided into two equally populated groups: one prescribed with a Persian medicinal herbal compound (n = 37) and a placebo group (n = 37). A Persian herbal medicine including fenugreek, sumac, and purslane is introduced. Biochemical parameters including 12-hour fasting serum levels of total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), very-low-density lipoprotein (VLDL), and triglyceride (TG) were measured before the initiation and after the completion of study protocol. Results. Percent changes of biochemical parameters include the following: intervention group = cholesterol: 35.22, Tg: 45.91, LDL: 24.81, HDL: 2.05, VLDL: 8.94 and placebo group = cholesterol: 6.94, Tg: −7.3, LDL: 7.37, HDL: 2.88, VLDL: −0.14. The serum levels of total cholesterol ( p = 0.01 ) and LDL ( p = 0.01 ) significantly decreased and no increase was recorded in HDL ( p = 0.03 ) levels over time in the intervention group. Furthermore, between-group analysis showed a statistically significant difference between the intervention and placebo groups in this regard. VLDL ( p = 0.2 ) and TG ( p = 0.2 ) levels also decreased, however not significantly. Conclusion. This study showed that a Persian medicinal herbal compound could be safe and beneficial to decrease the levels of serum cholesterol and LDL in dyslipidemic patients. However, larger long-term studies are recommended to clarify this effect.

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 HEQOL 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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