scholarly journals Effects of Ferula assa-foetida on clinical, hormonal and ultrasound parameters in young girls with polycystic ovary syndrome: a randomized, placebo controlled, triple-blinded

2020 ◽  
Author(s):  
Fatemeh Ghavi ◽  
somayeh abdolahian ◽  
Fatemeh Shakeri ◽  
Mahboubeh Taebi
Keyword(s):  
Clinical Trial ◽  
Polycystic Ovarian Syndrome ◽  
Endometrial Thickness ◽  
Intervention Group ◽  
Ovarian Follicles ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Young Girls ◽  
Ovarian Syndrome

Abstract Background: Polycystic ovarian syndrome is the most common endocrine disorder in reproductive aged women. As a result of side effect of pharmaceutical medications women are interested in using alternative medicines to treat. To determine the comparative effects of Ferula assa-foetida on androgenic hormone levels and ovarian features in patient with polycystic ovarian syndrome (PCOS). Methods: In this triple-blinded controlled clinical trial, 34 student participants were randomly divided in two groups. Intervention group received 100 mg of oleo-gum resin of Ferula assa- foetida, control group received oral paraffin (Placebo) twice daily for 3 months. The efficacy of this herbal medicines was measured after the 3-month intervention. Hormonal assay for evaluating Testosterone, DEHAS, Prolactin, TSH, FSH, LH levels and also trans abdominal ultrasound for evaluating ovarian volumes, number of follicles of both ovaries, and endometrial thickness. Were measured before and after the study. Results: In this study, significant changes in DEHAS and TSH level were observed (p value<0.03). The greatest reduction in the number of ovarian follicles was reported in the Ferula group (p value <0.00). Conclusion: Use of Ferula assa-foetida can be effected in decrease of DHEAS, TSH levels, and ovarian follicles number in young girls with PCOS.Trial registration: the Iranian Randomized Clinical Trial (IRCT2016040427207N1).url: https://www.irct.ir/trial/22343

scholarly journals Effects of Ferula on Polycystic Ovary Syndrome

2020 ◽  
Author(s):  
Ghavi Fatemeh ◽  
Somayeh Abdolahian ◽  
Shakeri Fatemeh
Keyword(s):  
Clinical Trial ◽  
Polycystic Ovary ◽  
Endometrial Thickness ◽  
Intervention Group ◽  
Herbal Medicines ◽  
Ovarian Follicles ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Ovarian Syndrome

Abstract BackgroundPolycystic ovarian syndrome is the most common endocrine disorder in reproductive aged women. As a result of side effect of pharmaceutical medications women are interested in using alternative medicines to treat. To determine the comparative effects of Ferula assa-foetida on androgenic hormone levels and ovarian features in patient with polycystic ovarian syndrome (PCOS). MethodsIn this triple-blinded controlled clinical trial, 34 student participants were randomly divided in two groups. Intervention group received 100 mg of oleo-gum resin of Ferula assa- foetida, control group received oral paraffin (Placebo) twice daily for 3 months. The efficacy of this herbal medicines was measured after the 3-month intervention. Hormonal assay for evaluating Testosterone, DEHAS, Prolactin, TSH, FSH, LH levels and also trans abdominal ultrasound for evaluating ovarian volumes, number of follicles of both ovaries, and endometrial thickness. Were measured before and after the study. ResultsIn this study, significant changes in DEHAS and TSH level were observed (p value<0.03). The greatest reduction in the number of ovarian follicles was reported in the Ferula group (p value <0.00). ConclusionUse of Ferula assa-foetida can be effected in decrease of DHEAS, TSH levels, and ovarian follicles number in young girls with PCOS.Trial registrationthe Iranian Randomized Clinical Trial (IRCT2016040427207N1).url: https://www.irct.ir/trial/22343

Effects of Ferula Assa-Foetida on Clinical, Hormonal and Sonography Parameters in Young Girls with Polycystic Ovary Syndrome: Pilot Randomized, Placebo Controlled, Triple-Blinded

2020 ◽  
Author(s):  
Fatemeh Ghavi ◽  
Somayeh Abdolahian ◽  
Fatemeh Shakeri ◽  
Mahboubeh Taebi
Keyword(s):  
Clinical Trial ◽  
Polycystic Ovarian Syndrome ◽  
Intervention Group ◽  
Ovarian Follicles ◽  
Control Group ◽  
P Value ◽  
Abdominal Sonography ◽  
Ovarian Volume ◽  
Young Girls ◽  
Ovarian Syndrome

Abstract Background: Polycystic ovarian syndrome is the most common endocrine disorder in reproductive aged women. As a result of side effect of pharmaceutical medications women are interested in using alternative medicines to treat. To determine the comparative effects of Ferula assa-foetida on androgenic hormone levels and ovarian features in patient with polycystic ovarian syndrome (PCOS). Methods: In this triple-blinded controlled clinical trial, 34 student participants were randomly divided in two groups. Intervention group received 100 mg of oleo-gum resin of Ferula assa- foetida, control group received oral paraffin (Placebo) twice daily for 3 months. The efficacy of this herbal medicines was measured after the 3-month intervention. Hormonal assay for evaluating Testosterone, DEHAS, Prolactin, TSH, FSH, LH levels and also abdominal sonography for evaluating ovarian volumes, number of follicles of both ovaries, and endometrial thickness. were measured before and after the study.Results: In this study, no significant hormonal changes were observed (p value>0.5). Although the greatest reduction in the number of ovarian follicles and ovarian volume was reported in the Ferula assa-foetide group (p value <0.01). Conclusion: Use of Ferula assa-foetida can be effected in decrease of ovarian volume and ovarian follicles number in young girls with PCOS.Trial registration: the Iranian Randomized Clinical Trial (IRCT2016040427207N1).url: https://www.irct.ir/trial/22343

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

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.

scholarly journals The effect of transcutaneous auricular stimulation on anxiety before colposcopy: A randomized clinical trial

2020 ◽  
Vol 37 (4) ◽  
pp. 405-415
Author(s):  
Samaneh Jouya ◽  
Nahid Golmakani
Keyword(s):  
Clinical Trial ◽  
State Anxiety ◽  
Intervention Group ◽  
Routine Care ◽  
T Test ◽  
Anxiety Level ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Significant Difference

Women experience a high level of anxiety and negative emotional responses during colposcopy, which results in women's' unwillingness to return for follow-up. Transcutaneous auricular stimulation may be useful in reducing anxiety. Therefore, the aim of this study was to determine the effect of transcutaneous auricular stimulation on anxiety before colposcopy. This randomized controlled clinical trial study was performed on 65 female candidates for colposcopy who were referred to Ghaem Hospital, Mashhad, Iran, in 2017. Women were randomized into one of the two groups. In the intervention group, a pointer Excel device was used for forty minutes before colposcopy; electrical stimulation at 4 points (Shenmen, relaxation, tranquillizer and endocrine) was performed on ears, with the frequency of 2 Hz for 30 seconds at each point. Women received routine care in the control group. The anxiety level was assessed by Spielberger Questionnaire before intervention and also 40 minutes after intervention. Data analysis was performed using the t-test, paired t-test, and MannWhitney test in SPSS software, version16. P value less than 0.05 was considered significant. After intervention, the state anxiety score was 43.9 ± 9.19 in the control group and 54.3 ± 9.07 in the intervention group, and the difference between the two groups was statistically significant (P = 0.00), while there was no significant difference in the level of trait anxiety in the two groups (P = 0.21). Regarding the reduction of state anxiety level after intervention, transcutaneous auricular stimulation is recommended as a suitable method to reduce anxiety of patients who are candidates for colposcopy.

Could Anise decrease the intensity of premenstrual syndrome symptoms in comparison to placebo? A double-blind randomized clinical trial

2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Maryam Farahmand ◽  
Davood Khalili ◽  
Fahimeh Ramezani Tehrani ◽  
Gholamreza Amin ◽  
Reza Negarandeh
Keyword(s):  
College Students ◽  
Clinical Trial ◽  
Premenstrual Syndrome ◽  
Intervention Group ◽  
Study Groups ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
P Value ◽  
Double Blind ◽  
High Prevalence

AbstractBackgroundPremenstrual syndrome (PMS) has a high prevalence among women of reproductive ages but despite its high prevalence, it has no determined and absolute treatment, so far. So, the aim of the present study was to compare the effect Pimpinella Anisum (Anise) with placebo on the intensity of the symptoms of PMS.MethodsThe present study was a randomized double-blind controlled clinical trial. College students who were suffering from PMS and had the inclusion criteria were selected and randomly assigned into two groups of intervention (Anise) and control (placebo). Participants in the intervention group, received 110 mg capsules of Anise three times day (a total dose of 330 mg per day); the control group received similar capsules with the same dosing that contained starch. Consumption of the capsules was started 7 days before the start of the menstruation and continued until 3 days after, which was a total of 10 days during two consecutive menstruation cycles. The intensity of the symptoms of premenstrual syndrome was measured using Premenstrual Symptoms Screening Tool (PSST). To compare the intensity of the symptoms between the two study groups, generalized estimating equation statistical method was used.ResultsEventually, sixty-seven 18–35 year old college students who were suffering from premenstrual syndrome were enrolled in the study. Comparing the mean score of the intensity of the syndrome between the two groups after the first and the second menstruation cycles showed a decrease in the intervention group to 13.9 (p-value<0.001; 95% CI: 16.5,−11.4) and 9.8 (p-value<0.001; 95% CI: 12.4,−7.3), respectively.ConclusionResults of the study showed that, in general, Anise was effective in decreasing the symptoms of premenstrual syndrome in comparison to placebo.

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

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.

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

2020 ◽  
Vol 9 ◽  
pp. 1918 ◽  
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] 

scholarly journals Effectiveness of a home care teaching program for prostatectomized patients: a randomized controlled clinical trial

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.

scholarly journals Efficacy of a Chinese Herbal Medicine Compound Zhangpi Ointment against Hydroxyurea-Induced Leg Ulcers: A Prospective, Randomized, Open-Label, Controlled Clinical Trial

2018 ◽  
Vol 2018 ◽  
pp. 1-8
Author(s):  
Yu-yang Pang ◽  
Yan Li ◽  
Gang Kui ◽  
Yong Tang ◽  
Ming-juan Liao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Myeloproliferative Neoplasms ◽  
Controlled Trial ◽  
Intervention Group ◽  
Complete Healing ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Leg Ulcers ◽  
Open Label ◽  
Chinese Herbal

Objective.The randomized controlled trial was to evaluate the efficacy of topical Chinese herbal Zhangpi Ointment for hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms.Patients and Methods.This single-center, prospective, randomized, open-label, controlled clinical trial conducted at Shanghai Ninth People’s Hospital enrolled 54 patients with hydroxyurea-induced leg ulcers. Patients were randomly assigned to the control group (n = 27) treated with chlorhexidine dressing or the intervention group (n = 27) treated with the Zhangpi Ointment. Finally, 26 patients in the control group and 23 patients in the intervention group completed 8 weeks of observation.Results.The rate of complete healing was 100% for the intervention group, which was significantly higher than that of the control group (96.15%) (P<0.05). Furthermore, the intervention group achieved a significantly higher rate of wound healing (95.56%) than the control group (69.02%) at week 4 (P<0.01). The intervention group took 34 ± 5 days to achieve complete healing while the control group took 41 ± 7 days (P< 0.01). Moreover, grade 3/4 side effects were observed in neither group.Conclusion.The Zhangpi Ointment is effective in promoting the healing of hydroxyurea-induced leg ulcers in patients with myeloproliferative neoplasms, providing a therapeutic option for a condition that is recalcitrant to conventional therapy.

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