scholarly journals Comparison of a Novel Herbal Medicine and Omeprazole in the Treatment of Functional Dyspepsia: A Randomized Double-Blinded Clinical Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-9
Author(s):  
Ghasem Bordbar ◽  
Mohammad Bagher Miri ◽  
Mahmoud Omidi ◽  
Saeed Shoja ◽  
Malihe Akhavan
Keyword(s):  
Clinical Trial ◽  
Herbal Medicine ◽  
Essential Oils ◽  
Functional Dyspepsia ◽  
Rating Scale ◽  
Response Rate ◽  
Intervention Group ◽  
Control Group ◽  
Improvement Rate ◽  
Epigastric Pain Syndrome

Background. The Trachyspermum ammi L. (TA), Anethum graveolens L. (AG), and Zataria multiflora Boiss (ZM) herbal oils are among the most used herbal products in traditional medicine as the antiseptic, anesthetic, carminative, and antispasmodic. However, there are no clinical studies to evaluate the efficacy of the herbs mentioned in the treatment of functional dyspepsia (FD). This study was designed to appraise the efficacy and safety of a novel herbal medicine consisting of ZM, AG, and TA essential oils compared to omeprazole in FD treatment. Methods. The present study was a randomized double-blind clinical trial with parallel groups in Iran. Patients in control and intervention arms received omeprazole 20 mg once a day and 250 mg soft-gel capsules containing 180 mg of essential oils of ZM, AG, and TA twice a day for two weeks, respectively. The primary outcome was the sufficient response rate in the postprandial distress syndrome (PDS) and/or epigastric pain syndrome (EPS) at the end of the intervention. Secondary outcomes were the improvement rate in the PDS, EPS, Gastrointestinal Symptom Rating Scale (GSRS), and quality of life scores. Also, safety and tolerability were assessed. Results. The within-group comparison of EPS, PDS, total GSRS, GSRS Pain, and GSRS Dyspepsia scores with that at the end of the treatment indicated a significant reduction in both control and intervention groups ( p < 0.001 ). However, after two weeks of treatment, the herbal medication and omeprazole arms were significantly different in the sufficient response rate based on PDS ( p < 0.01 ) and EPS ( p < 0.05 ) scores (78.3% (18/23) and 73.7% (14/19) in the intervention group vs. 36.4% (8/22) and 40.9% (9/22) in the control group). Also, the mean reduction in EPS ( p < 0.05 ), PDS ( p < 0.01 ), and GSRS ( p < 0.001 ) scores after treatment was significantly higher in the intervention group than control group. Conclusion. Based on the study findings, this herbal medicine can be considered as an appropriate treatment of FD. However, a larger multicenter trial is needed to confirm the results of the trial.

scholarly journals Evaluation of the Effect of Atorvastatin Administration on the Outcomes of Patients with Traumatic Brain Injury: A Double-Blinded Randomized Clinical Trial

2021 ◽  
Vol 11 (4) ◽  
Author(s):  
Farhad Soltani ◽  
Farahzad Janatmakan ◽  
Sara Jorairahmadi ◽  
Fatemeh Javaherforooshzadeh ◽  
Pooyan Alizadeh ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Randomized Clinical Trial ◽  
Rating Scale ◽  
Intervention Group ◽  
Control Group ◽  
Post Intervention ◽  
Disability Rating Scale ◽  
Double Blinded

Background: Traumatic brain injury (TBI) is one of the common causes of long-term disabilities and mortality. This study aimed to evaluate the effect of atorvastatin administration on the Glasgow Coma Scale (GCS), Glasgow Outcome Scale (GOS), and Disability Rating Scale (DRS) in patients with TBI. Methods: This double-blinded randomized clinical trial included 60 patients with TBI in Golestan Hospital of Ahvaz, Iran. After obtaining an informed consent from all patients, the patients were randomly assigned into two groups. For the intervention group, atorvastatin with a daily dose of 20 mg was used. The control group was administered the same amount of placebo for 10 days. Changes in the level of consciousness were measured using the GCS, and functional recovery rate in patients was measured by GOS and DRS in the third follow-up month. Results: According to the obtained results, compared with the control group, the atorvastatin administration significantly increased the level of GCS and DRS within 2 - 3 months post-intervention and improved GOS since the tenth day after the study (P < 0.05). Conclusions: The results revealed the positive effect of atorvastatin on the improvement of outcomes measurements such as GCS, DRS, and GOS in patients after moderate and severe TBI.

scholarly journals Efficacy of a combination of herbal gel versus topical diltiazem (2%) in chronic anal fissure healing: a randomized doubleblind clinical trial

2019 ◽  
Vol 8 (2) ◽  
pp. 139-145 ◽  
Author(s):  
Sedigheh Tavakoli-Dastjerdi ◽  
Malihe Motavasselian ◽  
Seyed Ahmad Emami ◽  
Marjan Mansourian ◽  
Amirhossein Sahebkar ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Wound Healing ◽  
Herbal Medicine ◽  
Anal Fissure ◽  
Chronic Anal Fissure ◽  
Herbal Remedy ◽  
Intervention Group ◽  
Dietary Advice ◽  
Control Group ◽  
Double Blind

Introduction: Chronic anal fissure (CAF) is a common painful ailment that adversely affects quality of life. Nonsurgical treatments such as topical diltiazem are routinely administered to patients with CAF. However, diltiazem is associated with side effects such as headache and allergic reactions, which often lead to discontinuation of the treatment. The aim of this study was to determine the efficacy and safety of a topical Persian herbal remedy with analgesic, antiinflammatory and antiseptic properties versus topical diltiazem (2%) in CAF healing. Methods: In this randomized double-blind clinical trial, 70 patients with CAF were randomly divided into an intervention group receiving topical herbal medicine and control group receiving topical diltiazem (2%) for 6 weeks. Both groups were given lifestyle and dietary advice including adherence to a high-fiber diet, avoidance of spicy foods, use of a laxative (psyllium powder) in case of constipation, and taking sitz baths. Severity of pain, bleeding, and itching were measured at the first visit as well as the first, third, and sixth weeks of treatment. Wound healing and epithelialization were evaluated by anal examination. The treatment and follow-up period was 12 weeks; 6 weeks for assessing the effect of treatment and 6 weeks for examining treatment maintenance and evaluating the percentage of recurrence. Results: The herbal medicine caused significant reduction in pain compared with diltiazem (P < 0.001). The herbal medicine had a significant effect in terms of wound healing at the end of the period (P < 0.001). Recurrence rate was lower in the intervention group (32%) than the control group (56%), though this difference was not significant (P = 0.323) Conclusion: Findings of this clinical trial suggest a higher efficacy of the combination herbal remedy versus topical diltiazem 2% in the management of pain and wound associated with CAF.

scholarly journals Efficacy and Safety of a Novel Herbal Medicine in the Treatment of Irritable Bowel Syndrome: A Randomized Double-Blinded Clinical Trial

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Ghasem Bordbar ◽  
Mohammad Bagher Miri ◽  
Mahmoud Omidi ◽  
Saeed Shoja ◽  
Malihe Akhavan
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Irritable Bowel Syndrome ◽  
Herbal Medicine ◽  
Essential Oils ◽  
Herbal Remedies ◽  
Control Group ◽  
Efficacy And Safety ◽  
Irritable Bowel

Background. The unresponsiveness to conventional pharmacological treatments and their side effects have led patients with irritable bowel syndrome (IBS) to use complementary and alternative medicine such as herbal remedies. Beside, Zataria multiflora Boiss (ZM), Trachyspermum ammi L. (TA), and Anethum graveolens L. (AG) are being used as an antiseptic, carminative, and antispasmodic in traditional medicine. This trial investigated the efficacy and safety of a combination of ZM, AG, and TA essential oils in the treatment of IBS. Method. The present study was a randomized double-blind clinical trial with parallel groups in Iran. Patients in the control arm received three tablets of 10 mg hyoscine butylbromide daily for two weeks, and the intervention arm was daily treated with two 250 mg softgel capsules containing 180 mg of essential oils of ZM, AG, and TA for two weeks. Primary outcomes were the response rates based on the IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR), and IBS Global Assessment Improvement (IBS-GAI) at the end and two weeks after the end of the intervention. Secondary outcomes were the improvement rates in IBS-SSS scores, improving the quality of life, safety, and tolerability. Results. The posttreatment improvement percentage based on IBS-AR, IBS-GAI, and IBS-SSS scales was 83.9%, 75%, and 87% in the intervention group and 37.9%, 27.5%, and 34.4% in the control group, respectively (P<0.001). Also, the improvement of the quality of life in the herbal medicine arm was significantly more than that in the control arm (P<0.001). Conclusions. According to the results, the herbal medicine investigated in this study can be considered an appropriate alternative treatment for IBS.

The effectiveness of discharge planning and range of motion (ROM) training in increasing muscle strength of nonhemorrhagic stroke patients

2018 ◽  
Vol 2 (3) ◽  
pp. 57
Author(s):  
Mohamat Iskandar
Keyword(s):  
Muscle Strength ◽  
Range Of Motion ◽  
Rating Scale ◽  
Discharge Planning ◽  
Intervention Group ◽  
Sampling Technique ◽  
Control Group ◽  
Planning Program ◽  
Stroke Patients ◽  
Central Java

Background: Non-hemorrhagic stroke patients experience hemiparesis, an improper handling results in joint contractures. Discharge planning combined with a range of motion (ROM) training given to patients and their families are expected to improve muscle strength in patients after returning from the hospital. Aims: This study is to identify the effectiveness of discharge planning in increasing muscle strength. Methods: This is a quasi-experimental study with a pre-posttest design. A total of 34 respondents were selected by cluster random sampling technique, from RAA Soewondo Pati General Hospital of Pati, Central Java, Indonesia. The respondents were divided equally into two groups; an intervention group (N = 17) was given a discharge planning program together with stroke information and range of motion (ROM) training while the control group (N = 17) received a standard discharge planning available in the hospital. Further, Muscle Rating Scale (MRS) was employed to assess the muscle strength on the 2nd, 7th, and 14th day after discharge planning presented to the nonhemorrhagic stroke patients. Results: This present study clearly acknowledges the standard discharge planning program available in the hospital improve the muscle strength of the upper and lower extremity in the nonhemorrhagic stroke patients just 2nd day after the care (pretest), and the significant improvement was observed until the day 14. Moreover, combining the care with ROM training at the intervention group faster the recovery and the muscle strength improved significantly at the 7th day and continue increase at the day 14. Looking to the muscle strength since the 2nd day to the day 14, respectively the muscle strength of upper and lower limb at the control group improved at the point of 0.588 and 0.882, while at the group received the ROM training reached the value of 1.472 and 1.412. Conclusions: The ROM training combined to the current discharge planning program will faster the muscle strength recovery of the nonhemorrhagic stroke patients. This research provide insight how family plays important role to the success in monitoring the rehabilitation and recovery progress. 

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

2019 ◽  
Vol 16 (2) ◽  
pp. 223-231 ◽  
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.

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.

Effects of a diuretic adjustment algorithm protocol on heart failure admissions: A randomized clinical trial

2021 ◽  
pp. 1357633X2110096
Author(s):  
Maria KEF Feijó ◽  
Karen Brasil Ruschel ◽  
Daniela Bernardes ◽  
Eduarda B Ferro ◽  
Luis E Rohde ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Randomized Clinical Trial ◽  
Intervention Group ◽  
Heart Association ◽  
Functional Class ◽  
Emergency Department Visits ◽  
Control Group ◽  
Point Change ◽  
Clinical Instability

Introduction The aim of this study was to evaluate the effectiveness of a diuretic adjustment algorithm (DAA) in maintaining clinical stability and reducing HF readmissions using telemonitoring Technologies. Methods Randomized clinical trial of patients with an indication for furosemide dose adjustment during routine outpatient visits. In the intervention group (IG), the diuretic dose was adjusted according to the DAA and the patients received telephone calls for 30 days. In the control group (CG), the diuretic dose was adjusted by a physician at baseline only. Co-primary outcomes were hospital readmission and/or emergency department visits due to decompensated HF within 90 days, and a 2-point change in the Clinical Congestion Score and/or a deterioration in New York Heart Association functional class within 30 days. Results A total of 206 patients were included. Most patients were male ( n=119; 58%), with a mean age of 62 (SD 13) years. Four patients (2%) in the IG and 14 (7%) in the CG were hospitalized for HF (odds ratio (OR) 0.31 (0.10–0.91); p=0.04). Multivariate analysis showed a reduction of 67% in readmissions and/or emergency department visits due to decompensated HF in the IG compared with the CG (95% CI 0.13–0.88; p=0.027). Regarding the combined outcome of HF readmission and/or emergency department visits or clinical instability, the IG had 20% fewer events than the CG within 30 days (IG: n=48 (23%), CG: n=70 (34%); OR 0.80 (0.63–0.93); p=0.03). Discussion Using DAA improved the combined outcome in these outpatients, with favorable and significant results that included a reduction in HF admissions and in clinical instability. (NCT02068937)

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.

Capnography and Pulse Oximetry Improve Fast Track Extubation in Patients Undergoing Coronary Artery Bypass Graft Surgery: A Randomized Clinical Trial

2021 ◽  
Author(s):  
Seyed Tayeb Moradian ◽  
Fatemah Beitollahi ◽  
Mohammad Saeid Ghiasi ◽  
Amir vahedian-azimi
Keyword(s):  
Clinical Trial ◽  
Pulse Oximetry ◽  
Fast Track ◽  
Artery Bypass ◽  
Bypass Graft ◽  
Intervention Group ◽  
Control Group ◽  
Artery Bypass Graft ◽  
Cabg Surgery ◽  
Non Invasive

Abstract Background Use of capnography as a non-invasive method during the weaning process for fast track extubation (FTE) is controversial. We conducted the present study to determine whether pulse oximetry and capnography could be utilized as alternatives to arterial blood gas (ABG) measurements in patients under mechanical ventilation (MV) following coronary artery bypass graft (CABG) surgery. Methods In this randomized clinical trial, 70 patients, who were candidates for CABG surgery, were randomly assigned into two equal groups (n = 35); the intervention group and the control group. In the intervention group, the ventilator management and weaning from MV was done using Etco2 from capnography and SpO2 from pulse oximetry. Meanwhile, in the control group, weaning was done based on ABG analysis. The length of intensive care unit (ICU) stay, time to extubation, number of manual ventilator setting changes, and alarms were compared between the groups. Results The end-tidal carbon dioxide (ETCO2) levels in the intervention group were completely similar to the partial pressure of carbon dioxide (PaCo2) in the control group (39.5 ± 3.1 vs. 39.4 ± 4.32, P > 0.05). The mean extubation times were significantly shorter in the intervention group compared to those in the control patients (212.2 ± 80.6 vs. 342.7 ± 110.7, P < 0.001). Moreover, the number of changes in the manual ventilator setting and the number of alarms were lower in the intervention group (P < 0.05). However, the differences in the length of stay in ICU between the two groups were not significant (P = 0.219). Conclusion According to our results, the use of non-invasive monitors, including capnography and pulse oximetry, is emphasized in order to utilize FTE after CABG surgery. Furthermore, it is a safe and valuable monitor that could be a good alternative for ABG in this population. Nevertheless, further studies with larger sample sizes and on different disease states and populations are required to assess the accuracy of our findings. Trial registration: IRCT, IRCT201701016778N6, Registered 3 March 2017, https://www.irct.ir/trial/7192

scholarly journals Assessment of Acupuncture and Moxibustion Effects on the Electrophysiological Properties of the Ulnar Nerve: A Nerve Conduction Study

2018 ◽  
Vol 4 (3-4) ◽  
pp. 198-207 ◽  
Author(s):  
Sónia Chan ◽  
Sérgio Ferreira ◽  
Bruno Ramos ◽  
Maria João Santos ◽  
Luís Carlos Matos ◽  
...  
Keyword(s):  
Electrical Stimulation ◽  
Ulnar Nerve ◽  
Rating Scale ◽  
Intervention Group ◽  
Maximum Amplitude ◽  
Numeric Rating Scale ◽  
Control Group ◽  
Reaction Velocity ◽  
Electrophysiological Properties ◽  
Acupuncture And Moxibustion

Background/Aims: Acupuncture and moxibustion, when used together, have act mechanically and thermally on treated reflexological areas. The main goal of this work was to evaluate the effects of acupuncture and moxibustion on the electrophysiological properties of the ulnar nerve. Methods: Electrical stimulation was applied to the ulnar nerve above the epi­condyle of 28 volunteers. A 20-V potential was applied, and after each 10 impulses it was increased by 10 V, up to a maximum of 80 V. At 20 and 80 V, the participants were asked to rate the discomfort from 0 to 10 on a Numeric Rating Scale for pain. After the first stimulation and data collection, the control group rested for 6 min, while the intervention group was submitted to acupuncture and moxibustion on Lingdao (HT 4). Following this period of time, a second electrical stimulation was performed on both groups. Results: The discomfort was greater in the intervention group during the second stimulation. The stimulus required to achieve the maximum amplitude decreased, but the changes were only statistically significant in the intervention group (p = 0.006). An increase in latency and a decrease in reaction velocity were noticed between the first and the second stimulation for both groups; however, only the control group presented statistically significant differences (p = 0.018 and p = 0.022, respectively). Conclusions: Acupuncture and moxibustion on HT 4 increased the electrical sensitivity, decreased the stimulus intensity to achieve the maximum amplitude, and avoided a significant increase in latency and decrease in reaction velocity in two consecutive electrical stimulations.

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