Showing 4 results for Clinical Trial
Azim Mirzazade, Akbar Fotouhi, Farshid Alla’oddini, Kamran Yazdani, Arash Arya, Fariba Asghari, Shahriar Shayan Far,
Volume 1, Issue 2 (7-2002)
Abstract
Introduction: Anethum is an herbal medicine composed of the three plants species Anethum, Fumaria and Cichorium, and has been widely marketed and prescribed as lipid-lowering agent in Iran in recent years. No controlled clinical trial of this medicine has so far been carried out, however. We studied the efficacy and short-term side effects of Anethum in patients with isolated hypertriglyceridaemia.
Methods: 151 people (54 men and 97 women) with serum triglyceride ≥250mg/dl and serum cholesterol <240mg/dl were enrolled in this study. Participants were randomly assigned to one of four treatment groups: Anethum, nicotinic acid, clofibrate, and placebo. They were seen at the Doctor Shariati University Hospital lipid clinic once every two weeks. Serum lipid profile was measured at 2 and 4 months after start of therapy. Relevant patient details, including sex, body mass index, mean total cholesterol and high-density lipoprotein, cigarette smoking, previous myocardial infarction, physical activity, and oral contraceptive use were recorded before enrolment.
Results: Four months after treatment was started, serum triglyceride had decreased 12.5% in the Anethum group and 6.8% in the placebo group (p=0.999). During the same period, serum triglyceride had decreased 48.8% in the nicotinic acid group and 54.4% in the clofibrate group (p=0.006 with respect to both placebo and Anethum). Furthermore, the nicotinic acid group showed a 7.8% decrease in serum total cholesterol (p=0.009 with respect to the other three groups). HDL-C decreased 9.8% in the Anethum group, 17.5% in the nicotinic acid group, 8.1% in the clofibrate group, and 9.1% in the placebo group (p=0.149 between first three groups and placebo). 81.8% of the nicotinic acid, 57.1% of the clofibrate, 8.0% of the Anethum and 30% of the placebo group experienced side effects during the same period. The most common complaints in the Anethum were actually non-specific ones.
Conclusion: We conclude that Anethum does not exert any therapeutic effect on isolated hypertriglyceridaemia.
Negin Masoudi Alavi, Fazl Allah Ghofranipour, Bagher Larijani, Fazl Allah Ahmadi, Asad Allah Rajab, Gholamhossein Babaei,
Volume 3, Issue 2 (6-2004)
Abstract
Background: Diabetes Mellitus is a common chronic disease with severe of complications. Proper glycaemic control can prevent these complications considerably. Evaluation of effectiveness of community based and patient centered interventions on glycaemic control, quality of life, patient satisfaction, patient knowledge and reported symptoms were the main aims of this research.
Methods: In a clinical trial, patients referring to Iranian Diabetes Association, who were more than 18 years old, divided to intervention and control group randomly. After three months of general interventions in both groups, including diabetes education and specific interventions including telephone calls, continuous corresponding and sending educational issues in intervention group, changes in variables were studied. Results: Among 52 patients in each group, 17 were male and 42 had type 2 diabetes. The average age was 49 in intervention and 51 in control group. Two groups had no significant difference in age, sex, type of diabetes, treatment method and duration of diabetes, other diseases and education. Both groups showed significant improvement in glycaemic control. The mean reduction in HbA1c was 1.45 in intervention and 0.86 percent in control group the difference is statistically significant (P= 0.02). Patient satisfaction increased in both groups. The satisfaction is significantly higher in intervention group (P=0.000). Knowledge has increased significantly in both groups the difference in groups is not significant. The improvement in Quality of Life was just significant in intervention group. The reported sign and symptoms have not changed in both groups.
Conclusion: Community based and patient centered interventions with emphasis on continuous education and support can improve glycemic control, quality of life, patient satisfaction and patient knowledge in diabetes mellitus.
Ozra Tabatabaei Malazy, Ramin Heshmat, Seyed Akhavan Hejazy Mogaddam Sa, Eghbal Taheri, Seddigheh Soheilykhah, Farzaneh Darvishzadeh, Bagher Larijani,
Volume 5, Issue 1 (8-2005)
Abstract
Background: Metformin is usually using for glycemic control in type 2 diabetes mellitus. The drug is the first line for obese patients without renal or liver failure. Different pharmaceutical types of Metformin are available. As a clinical trial, we compared effects of Aria Metformin (product of Aria pharmaceutical company, Iran) with Merck Metformin or Glucophage (product of Merck pharmaceutical company, France), in diabetic patients.
Methods: This double blind randomized clinical trial study performed with 60 non- pregnant diabetic patients, in order to comparison of therapeutic effects of combination therapy (Glibenclamide + Metformin "Aria or Merck") in a 12 weeks period. We evaluated FBS, BS 2hpp, HbA1c, lipid profile, liver function tests, weight, BMI and common or uncommon side effects.
Results: Not only each of two pharmaceutical types of Metformin had the same therapeutic effects for controlling of glycemia, lipid profile and weight, but also there were not difference between them in side effects. Distention was the most common side effects of two types products (33%). There is not significant difference between them in common side effects. 70% of patients were satisfied with each two kinds of Metformin.
Conclusion: It seems, in view of beneficial therapeutic effects of Aria Metformin, low rate of side effects, and finally low cost, Aria Metformin is a good choice.
Mohammad Jafar Mahmoudi, Soodabeh Alataab, Farshad Sharifi, Farhang Derakhshan, Hossein Fakhrzadeh,
Volume 13, Issue 6 (9-2014)
Abstract
Background: Metabolic syndrome is a cluster of disorders which altogether increase the risk of cardiovascular disease and type 2 Diabetes. We evaluated the effect of consumption of Omega-3 Fatty Acids on different components of this syndrome.
Methods: This was a double blind placebo controlled clinical trial on 199 elderly residents of Kahrizak charity foundation in Tehran. Participants were divided into two groups of intervention and control, consisting of 100 and 99 persons, respectively. The intervention group was given the Omega-3 Fatty Acid capsules contain 180 mg EPA and 120 mg DHA once daily. The control group was given placebo once per day. The duration of the study was 6 months in the beginning and after 6 months of the study, blood pressure, waist circumference and Serum levels of ESR, hs-CRP, APO B, APO A1 and Insulin were measured.
Results: The study was completed in 89 and 87 participants in the intervention and control groups, respectively. The mean age of intervention and control groups were 74.13 ± 9.96 and 75.17 ± 8.70 years, respectively. Consumption of Omega-3 Fatty Acids could decrease diastolic blood pressure (P = 0.001) and serum Triglyceride levels (P = 0.01) significantly compared to control group. No change was observed in other measured parameters.
Conclusion: Consumption of Omega-3 Fatty Acids with dosage used in this study could probably improve symptoms of Metabolic syndrome in the elderly.
