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IRCT20180609040020N1 IRCT 2018-06-15 Mazandaran University of Medical Sciences Effect of Hibiscus esculentus on blood sugar and lipids of Type 2 diabetic patients EHBSLD Evaluation the effect of Hibiscus esculentus on blood sugar and lipids of patients with type 2 Diabetes: A double blind clinical trial 2018-07-07 anticipated 66 Complete https://irct.ir/trial/31762 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomized block design, Blinding description: Patients are randomly assigned to two groups of intervention and control based on randomized block design. For the randomized assignment, each group is considered 4 persons in 4 conditions, therefore 6 conditions may happen: AABB-ABAB-ABBA-BAAB-BABA-BBAA. The type of being intervention or control of A or B is determined by the statistical consultant. The color of capsules is similar for intervention and control group and the patients, clinical and outcome evaluators are unaware of the contents of the capsules and the way of patients’ assignment into two groups of intervention and control. N/A Type 2 diabetes. Intervention 1: Intervention group: Type 2 diabetic patients who use powder of Hibiscus esculentus with the dose of 1000 milligrams three times daily before breakfast, lunch, and dinner for 60 days. Intervention 2: Control group: Type 2 diabetic patients who use two placebo capsules three times daily before breakfast, lunch, and dinner for 60 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is not more information.
public Ali Hesamzadeh
Laleh St.
Sari Iran (Islamic Republic of) 4817914934 +98 11 3321 9437 a.hesamzadeh@mazums.ac.ir Mazandaran University of Medical Sciences scientific Ali Hesamzadeh
Laleh St.
Sari Iran (Islamic Republic of) 4817914934 +98 11 3321 9437 a.hesamzadeh@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Having type 2 diabetes at least three months before entering the study Age between 20 and 80 years Hemoglobin A1C more than 7.5 at time of entering the study Using a contraceptive method in women during reproductive age who entered the study 20 years 80 years Both Unwillingness of the patient Having known Immune deficiency Pregnancy and breastfeeding Obeying a diet regimen or especial kind of exercise Using supplements containing Hibiscus esculentus Cardiovascular diseases History of hepatic and renal diseases Uncontrolled thyroid disease History of diabetic ketoacidosis Creatinine more than 2 Using drugs that have an effect on blood sugar level including Corticosteroids and thiazides Known allergy to Hibiscus esculentus plant Manifestation of acute physical problems during the intervention Changing the type of treatment and manifestation of hypoglycemia symptoms Severe Weight loss at least 10 percent during the past 6 months E11 Type 2 diabetes mellitus Treatment - Drugs Placebo Intervention group: Type 2 diabetic patients who use powder of Hibiscus esculentus with the dose of 1000 milligrams three times daily before breakfast, lunch, and dinner for 60 days. Control group: Type 2 diabetic patients who use two placebo capsules three times daily before breakfast, lunch, and dinner for 60 days. Fasting Blood Sugar. Timepoint: At the beginning of the intervention and at the end of intervention on the day 60. Method of measurement: Blood test. Hemoglobin A1C. Timepoint: En At the beginning of the intervention and at the end of intervention on the day 60. Method of measurement: Blood test. Cholesterol. Timepoint: At the beginning of the intervention and at the end of intervention on the day 60. Method of measurement: Blood Test. Mazandaran University of Medical Sciences Approved 2018-05-29 Ethics committee of Mazandaran University of Medical Sciences Razi St. Sari Mazandaran Iran (Islamic Republic of)