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

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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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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Preliminary Results on the Effectiveness of a Nutrition Intervention in Lowering Diabetes Risk in Prediabetic People Living with HIV (PLWH) in MASH Cohort (OR36-06-19)

Current Developments in Nutrition ◽

10.1093/cdn/nzz035.or36-06-19 ◽

2019 ◽

Vol 3 (Supplement_1) ◽

Author(s):

Alicia Sneij Perez ◽

Adriana Campa ◽

Leslie Seminario ◽

Sabrina Martinez ◽

Fatma Huffman ◽

...

Keyword(s):

Blood Glucose ◽

Fasting Blood Glucose ◽

Intervention Group ◽

Nutrition Intervention ◽

Control Group ◽

Reactive Protein ◽

Research Initiative ◽

Significant Difference ◽

Hs Crp

Abstract Objectives The objective of this study is to assess the effectiveness of a 6-month nutrition intervention to improve glycemic parameters and inflammation in prediabetic PLWH on stable ART with undetectable HIV viral load. Methods A 6-month randomized, controlled nutrition intervention was conducted in prediabetic PLWH. The study participants for the intervention were recruited from the Miami Adult Studies for HIV (MASH) cohort at the FIU-Borinquen Research Clinic. Upon their consent, the participants were randomized into the intervention group or the control group. Participants randomized in the intervention group met once a month for approximately 1 hour where they received medical nutrition therapy, nutrition counseling and nutrition education; participants randomized into the control group received educational material at baseline. Blood was drawn at baseline and at 6-month to measure fasting blood glucose (FBG) and high sensitivity C-reactive protein (hs-CRP). Results A total of 38 participants were recruited and randomized into either the intervention group (n = 20) or the control group (n = 18). We found that the FBG for the 6-month follow-up for the intervention group was significantly lower than the baseline FBG values of the same study group (paired t-test; P = 0.031). No significant difference was found in the control group between the baseline and 6-month fasting blood glucose values (P = 0.068). Moreover, no significant difference was found in pre/post C-reactive protein (CRP) levels in the intervention or control group (paired t-test; P = 0.404 and P = 0.117 respectively). There was a significant difference in CRP levels at baseline (P = 0.028) between the study groups but no difference at the 6-month follow up (Mann Whitney U test: P = 0.430). Conclusions The results from this intervention support the notion that a nutrition intervention is effective in prediabetic PLWH to lower diabetes risk by significantly lowering fasting blood glucose and may be implemented into larger scale interventions; however, no significant changes was seen in hs-CRP values between the 2 groups. Funding Sources National Institute of General Medical Sciences (NIGMS): Research Initiative for Scientific Enhancement (RISE), Biomedical Research Initiative (BRI) Grant, National Institute on Drug Abuse 5U01DA040381-03 and FIU-Dissertation Funding.

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Eremostachys laciniata as effective as rectal diclofenac suppository in cesarean section pain relief: A triple-blind controlled clinical trial

Journal of Endometriosis and Pelvic Pain Disorders ◽

10.1177/2284026519899010 ◽

2020 ◽

Vol 12 (1) ◽

pp. 26-34

Author(s):

Shabnam Mohammad Pour ◽

Sevil Hakimi ◽

Abbas Delazar ◽

Yousef Javad Zadeh ◽

Fatemeh Mallah

Keyword(s):

Clinical Trial ◽

Cesarean Section ◽

Intervention Group ◽

Massive Hemorrhage ◽

Control Group ◽

Controlled Clinical Trial ◽

Total Extract ◽

Significant Difference ◽

Healing Score ◽

Distress Scale

Background: Pain and distress are two common complications of cesarean section. Among complementary therapies, Eremostachys was introduced as a pain mitigator. This study aimed at investigating the effect of Eremostachys laciniata on cesarean section pain and distress. Materials and methods: This randomized clinical trial was conducted on 86 women who gave childbirth by cesarean section. The control group received 50 mg rectal diclofenac suppository every 8 h for 3 days, and the intervention group received 35 mg E. laciniata total extract suppository every 8 h up to three doses. Pain was measured with the Visual Analogue Scale at 8, 16, and 24 h after cesarean section. The Symptom Distress Scale was completed at 8 and 24 h after cesarean section. The Redness, Edema, Ecchymosis, Discharge, Approximation scale was completed 5 days after cesarean section. Findings: Pain score at 8, 16, and 24 h after surgery (15 min after intervention) was not significantly different between the intervention and control groups. The distress score 24 h after cesarean section showed a significant difference in favor of the control group according to Friedman’s test. There was a significant difference between the two groups in wound healing score, which indicated better efficacy of rectal diclofenac suppository than E. laciniata suppository. We assessed nausea, vomiting, headache, massive hemorrhage, and any type of anaphylactic reaction. No side events were observed in two groups. Conclusion: Rectal E. laciniata suppository could be introduced as a low-complication, appropriate, and effective medication in controlling pain and distress after cesarean section; more studies should be conducted on this matter.

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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 a health literacy approach to counselling on the lifestyle of women with gestational diabetes: A clinical trial

F1000Research ◽

10.12688/f1000research.13838.1 ◽

2018 ◽

Vol 7 ◽

pp. 282 ◽

Cited By ~ 2

Author(s):

Mehrafza Gharachourlo ◽

Zohreh Mahmoodi ◽

Mahnaz Akbari Kamrani ◽

Maryam Tehranizadeh ◽

Kourosh Kabir

Keyword(s):

Clinical Trial ◽

Health Literacy ◽

Gestational Diabetes ◽

Intervention Group ◽

Trial Registration ◽

Control Group ◽

Controlled Clinical Trial ◽

Unhealthy Lifestyle ◽

Pregnancy Care ◽

The Mean

Background: Gestational diabetes is a common pregnancy disorder that affects the mother’s and neonate’s health. The present study was conducted to investigate the effect of a health literacy approach to counselling on the lifestyle of women with gestational diabetes. The present randomized controlled clinical trial was conducted in 2017 using a parallel design. The subjects included 84 eligible women presenting to Alborz and Kamali Hospitals, Karaj, Iran. Methods: Convenience sampling was first used to select the subjects. They were then assigned to an intervention or control group based on randomized blocks of four. Both groups attended counselling sessions. The mothers in the intervention group attended six sessions of counselling with a health literacy approach in addition to counselling on routine pregnancy care. The control group attended counselling sessions on safe pregnancy care and received a training package containing all the subjects discussed in the intervention group. The Lifestyle Questionnaire and the Iranian Health Literacy Questionnaire were completed by the mothers at the beginning and at the end of the sessions as well as three weeks after the sessions. The data obtained were analyzed in SPSS-19. Results: According to the study findings, the scores of lifestyle (P=0.8) and health literacy (P=0.423) showed no significant differences between the intervention and control groups before the intervention. Significant differences were, however, observed in the mean scores of lifestyle and health literacy between the two groups immediately and three weeks after the intervention. Comparing the means showed a higher increase in the mean scores in the intervention group (P<0.001). Conclusions: Providing counselling services by midwives can significantly help modify mothers’ unhealthy lifestyle choices and increase their health literacy; therefore, reducing maternal and neonatal consequences, especially in high-risk pregnancies. Trial registration number: IRCT2017021427728N3 Trial registry: Iranian Registry of Clinical Trials Trial registration date: 5th April 2017

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Effectiveness of Olea Herbal Ointment on Episiotomy Wound Healing Among Primiparous Women: A Randomized Clinical Trial

Jundishapur Journal of Natural Pharmaceutical Products ◽

10.5812/jjnpp.104570 ◽

2021 ◽

Vol In Press (In Press) ◽

Author(s):

Shokoufeh Torkashvand ◽

Fatemeh Jafarzadeh-Kenarsari ◽

Yalda Donyaei-Mobarrez ◽

Bahare Gholami Chaboki

Keyword(s):

Clinical Trial ◽

Wound Healing ◽

Intervention Group ◽

Repeated Measure ◽

Control Group ◽

Controlled Clinical Trial ◽

Exact Test ◽

Significant Difference ◽

Perineal Region ◽

Primiparous Women

Background: Episiotomy is a surgical incision in the perineal region to increase the vaginal diameter during delivery. Since the perineal region is not well visible to the mothers and there is a possibility of infection for the episiotomy wound by vaginal and rectal bacteria, such a cut is associated with infection and delay in wound healing. Objectives: This study aimed to detect the effect of Olea ointment on episiotomy wound healing among primiparous women. Methods: This randomized controlled clinical trial included 73 women referring to the Al-Zahra educational, research, and remedial center in Rasht, Iran, during 2017 - 18. Women were randomly assigned into two groups: Intervention group (n = 39) and control group (n = 34). Episiotomy wound healing was assessed using the REEDA scale prior to the intervention, 2 and 24 hours following the first intervention, and 5 and 10 days after delivery. Statistical analysis was performed using Fisher’s exact test, Mann-Whitney U test, independent t-test, repeated-measure test, Friedman test, and chi-square. Results: The mean baseline scores of REEDA was 2.72 ± 0.46 in the Olea ointment group and 2.71 ± 0.46 in the control group; however, there no statistically significant difference between the two groups. On the other hand, the episiotomy healing scores in the Olea ointment group were significantly lower than those of the control group at four intervals in the follow-up assessments: -0.34 (95% CI: -0.56 to -0.12) two hours after intervention, -0.63(95% CI: -0.89 to -0.37) 24 hours after intervention, -0.30 (95% CI: -0.48 to -0.12) on Day 5 postpartum, and -0.29 (95% CI: -0.46 to -0.13) on Day 10 postpartum. Conclusions: The present findings suggested that the Olea ointment facilitated wound healing episiotomy; however, further studies are suggested to support these data.

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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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Efek konsumsi yogurt terhadap glukosa darah puasa pada penyandang diabetes melitus tipe 2

JURNAL GIZI INDONESIA ◽

10.14710/jgi.8.1.40-44 ◽

2020 ◽

Vol 8 (1) ◽

pp. 40

Author(s):

Farah Nuriannisa ◽

Nyoman Kertia ◽

Lily Arsanti Lestari

Keyword(s):

Blood Glucose ◽

Controlled Trial ◽

Health Centre ◽

Fasting Blood Glucose ◽

Intervention Group ◽

Control Group ◽

Double Blind ◽

Significant Difference ◽

Before And After ◽

Reduce Blood Glucose

Background: Generally, patients with type 2 diabetes mellitus (T2D) have dysbiosis condition. Dysbiosis can increase oxidative stress that leads to hyperglycemia. Previous researches showed that yogurt consumption can reduce blood glucose in T2D, so it can be used as an alternative healthy snack for T2D patients.Objectives: To investigate the effects of probiotic and conventional yogurt with dosage 100ml/day on fasting blood glucose (FBG) in T2D patientsMethods: Randomized controlled trial, double blind with pre-post group design. The 30 T2D patients from 3 publics health centre in Yogyakarta, were assigned to two groups. Each group, either control or intervention group, received 100 ml/d of yogurt for 4 weeks. FBG samples was assessed before and after intervention periodResults: FBG significantly decreased in both group, which was -27 mg/dL in control group (p<0.05) and -19 mg/dL in intervention group (p<0.05). No significant difference in FBG change between intervention and control group, but control group has greater reduction in FBG compared to intervention group. Conclusion: Conventional yogurt has no significant difference effect in FBG change compared to probiotic yogurt.

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Atorvastatin and standard treatment of Helicobacter pylori: Single Blinded Randomized Controlled Clinical Trial

10.1101/2020.05.29.20117200 ◽

2020 ◽

Author(s):

Mohammad Reza Mohammad Hoseini Azar ◽

Parham Portaghali ◽

Ali Jafari ◽

Amin Sedokani

Keyword(s):

Clinical Trial ◽

Helicobacter Pylori ◽

Standard Treatment ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

P Value ◽

Bismuth Subcitrate ◽

Significant Difference ◽

H Pylori

AbstractBackgroundConsidering the increase in drug resistance over time to Helicobacter pylori treatment relying on the anti-inflammatory and antibacterial effects of atorvastatin to increase the success rate of H. pylori eradication, we examined the effect of adding atorvastatin to standard treatment of H. pylori eradication.Materials and MethodsA total of 186 symptomatic patients who had been diagnosed with Helicobacter pylori infection and tested for H. pylori eradication were examined by a pathological response or positive urea breath test. Patients who received atorvastatin in addition to standard treatment were also identified based on a table of random numbers. Standard treatment included a 240mg bismuth subcitrate tablet, a 40mg pantoprazole tablet, a 500mg metronidazole tablet, and 2 capsules of 500mg amoxicillin, all taken BID for 14 days. After 4 weeks of treatment, all patients underwent stool testing for H. pylori fecal antigen. If the test was positive, the request was considered a failure of treatment, and if the test was negative, it was considered a successful eradication of H. pylori. The clinical trial registration code for this study is IRCT20190823044589N1.ResultsThe eradication rate of H. pylori was 80% in the control group and 80.9% in the intervention group, which did not show a statistically significant difference between the two groups (P-value = 0.971).ConclusionAdding atorvastatin to 4-drug regimen of PPI, bismuth subcitrate, amoxicillin, and metronidazole as the first line of treatment for H. pylori eradication is ineffective.

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Effects of Tarragon Powder on Glucose Metabolic Changes, Lipid Profile and Antioxidant Enzyme Levels in Type 2 Patients with Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial

Jundishapur Journal of Natural Pharmaceutical Products ◽

10.5812/jjnpp.102469 ◽

2021 ◽

Vol 16 (1) ◽

Author(s):

Hossein Khadem Haghighian ◽

Mohammadreza Shiran ◽

Ozra Akha ◽

Zahra Ghafouri ◽

Ehsan Ghaedi ◽

...

Keyword(s):

Clinical Trial ◽

Lipid Profile ◽

Antioxidant Status ◽

Fasting Blood Glucose ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Antioxidant Profile ◽

Patients With Diabetes

Background: The antioxidant and anti-inflammatory properties of tarragon make it known as an antidiabetic plant. Diabetes mellitus, an endocrine, metabolic disease, is a leading global health emergency and associated with serious complications. Objectives: This study aimed to assess the effects of tarragon powder supplementation on glucose metabolism, lipid profile, and antioxidant status in the diabetic population. Methods: Patient screening and selection for this clinical trial lasted one month. Tarragon supplement consumption by patients lasted 2 months (8 weeks); meanwhile, they were followed up. Sixty male and female patients with type 2 diabetes were randomly assigned to the tarragon receiver group (n = 30) and placebo receiver group (n = 30). The intervention group received a tarragon capsule (500 mg) 3 times a day, and the control group received placebo capsules. Fasting blood glucose (FBG), two-hour postprandial glucose (2-hpp), glycated hemoglobin (HbA1c), insulin, lipid, and antioxidant profile were evaluated at the start and the end of the research. Results: In the tarragon receiver group, FBG, 2-hpp, HbA1c%, insulin resistance, lipid, and antioxidant profile significantly improved, compared to the placebo group, after adjuvant therapy with tarragon (P < 0.05). Conclusions: Supplementation with tarragon powder in type II patients with diabetes for 2 months exerts a beneficial effect on improving the glycemic profile, lipid profile, and antioxidant status.

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