The Efficacy of The Administration of BifidobacteriumLactis For Treatment of Infantile Colic: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Abstract The aim of this trial was to evaluate the efficacy of Bifidobacterium Lactis administration on infantile colic (IC). In this double blind randomized, placebo‐controlled clinical trial, infants with IC diagnosis, exclusive breastfeeding, gestational age more than 37 weeks and birth weight more than 2500 gram were included. The selected infants randomly allocated in the two groups of BBcare group, treated with Bifidobacterium animalis subsp. lactis and the control group treated with placebo, 5 drops per day, for 6 weeks. The mean of crying, vomiting episodes and defecation number at baseline and during follow ups (40 and 60 days after intervention) were compared between the two studied groups. In this study from initially enrolled neonates, 40 and 38 neonates in BB-12 and placebo groups completed the study. In BB-12 group number of defecation, crying and vomiting episodes decreased significantly during intervention till 60 days after probiotic administration(P<0.05).In the placebo group there was significant decrease for crying and vomiting episodes between baseline and 60 days after intervention(P<0.05). Between group analyses indicated that there was significant difference between groups regarding mean of crying and vomiting episodes and number of defecation ,60 days after intervention(P<0.05).Conclusion: Findings of our study offer compelling signals for the effectiveness of Bifidobacterium animalis subsp. lactis BB‐12 in the management of some intestinal problems. These findings could be supportive evidences for the important role of gut microbiota as goal of intervention to improvement in bowel movement and comfortable defecation in IC.

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

BMC Research Notes ◽

10.1186/s13104-021-05667-9 ◽

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).

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The Effect of Melissa Officinalis Syrup on Patients With Mild to Moderate Psoriasis: a Randomized, Double-blind Placebo-controlled Clinical Trial

10.21203/rs.3.rs-322268/v1 ◽

2021 ◽

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, ninety-five 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).

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Efficacy of Aloe vera/ Plantago Major Gel in Diabetic Foot Ulcer: A Randomized Double-Blind Clinical Trial

Current Drug Discovery Technologies ◽

10.2174/1570163815666180115093007 ◽

2019 ◽

Vol 16 (2) ◽

pp. 223-231 ◽

Cited By ~ 2

Author(s):

Younes Najafian ◽

Zahra M. Khorasani ◽

Mona N. Najafi ◽

Shokouh S. Hamedi ◽

Marjan Mahjour ◽

...

Keyword(s):

Clinical Trial ◽

Diabetic Foot ◽

Intervention Group ◽

Aloe Vera ◽

Foot Ulcer ◽

Diabetic Foot Ulcer ◽

Control Group ◽

Plantago Major ◽

Double Blind ◽

Significant Difference

Background:Diabetic foot ulcer (DFU) is one of the most common complications of diabetic patients. Mostly, non-healing DFU leads to infection, gangrene, amputation and even death. High costs and poor healing of the wounds need a new treatment such as alternative medicine. So, the aim of this study was to evaluate the efficacy of Aloe vera/ Plantago major gel (Plantavera gel) in healing of DFUMethods:Forty patients with DFU enrolled in a double-blind randomized clinical trial. The patients who were randomly assigned into the intervention group (n = 20), received topical Plantavera gel in addition to the routine cares, whereas the patients in the control group (n = 20), received topical Placebo gel in addition to the routine cares. Intervention was done twice a day for 4 weeks in the both groups. Photography and an evaluation of DFU healing were conducted by a checklist and then were scored at baseline and at the end of each week. The collected data was analyzed by SPSS software.Results:At the end of the study, there was a significant difference between the two groups in terms of total ulcer score (P<0.001) and Plantavera gel significantly reduced the ulcer surface comparing with the control group (P=0.039). However, there was not a significant difference between the two groups (P=0.263) in terms of the ulcer depth. During this study, no side effect was observed for Plantavera gel in the intervention group.Conclusion:Topical Plantavera gel seems to be an effective, cheap and safe treatment. Of course, further studies are required to confirm the properties of the wound healing of this gel.

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

BMJ Open ◽

10.1136/bmjopen-2020-041958 ◽

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.

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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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Curcumin nanomicelle versus curcumin improves lipid profile, stress oxidative factors and inflammatory markers in patients undergoing coronary elective angioplasty; A Randomized Clinical Trial

10.21203/rs.2.18679/v1 ◽

2019 ◽

Author(s):

Bijan Helli ◽

Hadis Gerami ◽

Maria Kavianpour ◽

Habib Heybar ◽

Seyed Kianoosh Hosseini ◽

...

Keyword(s):

Clinical Trial ◽

Lipid Profile ◽

Inflammatory Markers ◽

Interleukin 1 ◽

Stress Index ◽

Inflammatory Factors ◽

Control Group ◽

Controlled Clinical Trial ◽

Double Blind ◽

Stress Oxidative

Abstract Background: Curcumin exhibited antioxidant and anti-inflammatory effects. The aim of this study, assess and compare curcumin and nano- curcumin effects on lipid profile, oxidative stress index and inflammatory factors of heart patients.Methods: This Randomized, Double-Blind, Placebo-Controlled Clinical Trial conducted on 90 patients undergoing coronary elective angioplasty. Patients were randomly divided into 3 groups. The first group received a 500 mg capsule of curcumin daily. The second group received an 80 mg capsule of nano- curcumin daily. The placebo group also received capsules similar to curcumin for 8 weeks. Lipid profile, stress oxidative factors and inflammatory markers measured in baseline and end of the investigation.Results: At the end of study, statistically significant changes was seen in the total cholesterol (TC), triglyceride (TG) and low density lipoprotein (LDL) in the intervention groups to the control group (p<0.05). These changes in the nano-curcumin group were greater than the curcumin group. Curcumin and nano-curcumin supplementation also caused a statistically significant improvement in plasma levels of total antioxidant capacity (TAC), malondialdehyde (MDA), Superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), high-sensitivity C-reactive protein (hs-CRP), Interleukin 1 beta (IL-1β) and tumor necrosis factor alpha (TNF-α) in comparison to the placebo (p<0.05).Conclusion: Complementary therapy of cardiovascular patients with curcumin and nano-curcumin supplements, could improve lipid profile, stress oxidative index and, inflammatory factors. The effects of curcumin on nano formula may be better for cardiac patients due to high bioavailability. However, further investigation is suggested in this regard.

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Effect of Probiotics on Allergic Rhinitis: A Randomized, Controlled, Clinical Trial

Galen Medical Journal ◽

10.31661/gmj.v9i0.1918 ◽

2020 ◽

Vol 9 ◽

pp. 1918 ◽

Cited By ~ 1

Author(s):

Mahnaz Sadeghi-Shabestari ◽

Yalda Jabbari Moghaddam ◽

Hasan Rezapoor ◽

Mojataba Sohrabpour

Keyword(s):

Clinical Trial ◽

Allergic Rhinitis ◽

Standard Therapy ◽

Control Group ◽

Controlled Clinical Trial ◽

P Value ◽

Nasal Discharge ◽

Oral Corticosteroids ◽

And Control

Background: Allergic rhinitis (AR) is one of the most common diseases in the world and affects about 10-50% of the general population. Probiotics are live microorganisms that help the normal state of the intestine, and if prescribed correctly, they can stimulate the mucosal immune system to prevent inflammatory symptoms of allergy and atopy. The present study aims to investigate the role of probiotics in the treatment of AR when added to standard therapy as adjuvant agents. Materials and Methods: In this clinical trial study, 28 patients older than 15 years with AR randomly divided into probiotics and control groups. The probiotics group received standard therapy for AR accompanied by probiotic capsules every 12 hours for eight weeks, whereas the control group received standard therapy for AR with placebo capsules as the same protocol. Data were analyzed using SPSS Version 23 (IBM Corporation, Armonk, NY, USA) and, the P-value less than 0.05 was considered statistically significant. Results: In the probiotics group, 14.3% of patients had sneezing at the baseline, which significantly decreased to 4.6% (P<0.01). Also, the necessity for nasal and oral corticosteroids after treatment with probiotics in the probiotics group was less than the control group (P<0.01). Although cough, nasal discharge, conchae hypertrophy, and night sleep disorders reduced after treatment with probiotics, this reduction was not statistically significant between the two groups. Conclusion: Based on the results of this clinical trial, the use of probiotics had no significant effect on the outcome of patients with AR. [GMJ.2020;9:e1918]

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THE EFFECTS OF CURCUMIN ADMINISTRATION ON EXPRESSION PATTERNS OF VEGF AND COX-2 IN FERTILE ENDOMETRIUM: A RANDOMISED CLINICAL TRIAL

International Journal of Applied Pharmaceutics ◽

10.22159/ijap.2019.v11s6.33581 ◽

2019 ◽

pp. 149-152

Author(s):

RAJUDDIN RAJUDDIN ◽

BUDI WIWEKO ◽

LUTFI NUGROHO

Keyword(s):

Clinical Trial ◽

Biological Activities ◽

Expression Patterns ◽

Control Group ◽

Controlled Clinical Trial ◽

Vegf Expression ◽

Double Blind ◽

Endometrial Stromal Cells ◽

Cox 2 ◽

Fertile Women

Objective: Curcumin (diferuloylmethane) is a a compound isolated from turmeric with biological activities, including antifertility. Curcumin inhibits COX-2 expression in granulosa cells of ovarian follicles and disrupts vascular endothelial growth factor (VEGF) derived angiogenesis in the endometrium, reducing endometrial receptivity. The purpose of this study was to examine the effects of curcumin on COX-2 and VEGF expression in endometrium of fertile women. Methods: A prospective double-blind placebo-controlled clinical trial was conducted in a group of fertile women with regular menstrual cycles, aged between 20-30 y, married, and with children. Subjects were divided into a group receiving daily 800 mg encapsulated curcumin. Curcumin orally for ten days, starting on the third day of the first menstrual day, and a control group. Endometrial biopsy was performed using a microcuret and immunohistochemistry was used to assess VEGF and COX-2 expression. The results were analysed using an independent sample t-test. Results: In the curcumin-treated group, VEGF expression was significantly lower than the control group (p<0.05), and COX-2 expression was higher but not significantly so (p>0.05). Conclusion: The curcumin causes VEGF expression in endometrium is lower and negatively affects the growth of endometrial stromal cells.

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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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