Effect of Citrullus Colocynthis Schrad comparison with Plasebo on dyslipidemia in 2 type diabetic patients: Clinical trial double blind

The aim of this study is to evaluate the effect of this plant on blood lipoproteins on type 2 diabetic patients.

This study is a phase 2 clinical trial, a randomized double-blind and random sequences generated based on a sample of randomly placed in two groups and the placebo group. Related information is obtained through interviews and laboratory measurements. The subjects were selected from patients with type 2 diabetes to number 70 in the diabetes clinic in Sabzevar, Iran.

The target population included all patients who have type 2 adult onset diabetes health records at the clinic Sabzevar University of Medical Sciences. Samples were randomly assigned into two groups of intervention and placebo groups. To duplicate this research, cans containing Handal or placebo capsules is coded by an individual other than the researcher. At the start of the study, all patients receive 5 ml of blood intravenously in fasting state. The samples are asked to make no changes in their diet and physical activity during the study period and to inform any researchers about any changes in their medicines. Drug use will continue until the end of the 8th week. At the end of the 8th week, blood samples are taken and the study variables are reviewed. The results are compared at week 8 with the starting values of the study and the percentage of changes is calculated.

Inclusion criteria were: having uncontrolled blood lipids (LDL level greater than 100 mg/dl) at least 4 months before the beginning of study and receiving Statins as well as low fat diet; being younger than 65 and older than 40 years old; having dossier in the diabetes clinic; The patient's willingness to participate in the research and being diabetic Type 2 for at least 1 year. exclusion criteria were: Having cardiovascular diseases, respiratory disease, gastrointestinal diseases, liver, kidney or any infectious diseases; being pregnant or breastfeeding and having previous history of paroxysm or surgery on the digestive system, unwillingness to continue cooperation, sick travel or death, create unwanted side effects, do not take medicine for more than a week, the occurrence of a stressful event in life and body mass index (BMI) lower than 18.5 and higher than 25.

In the intervention group, the specimens for 8 weeks Handal capsules (125 mg) once a day (before lunch) receive. In the same manner the placebo group received placebo capsules containing starch and tragacanth (125 mg) to receive. Preparation of this capsule is carried out at the Faculty of Pharmacy of Traditional Medicine, University of Tehran. Plants used in this compound are used after the approval of the relevant specialists and receive the Herbarium number.

The main outcome of this study, the percentage change in serum LDL; triglycerides; total cholesterol and serum HDL from beginning of study to end it.

Dr Mohamadzadeh Mohamad. Research Deputy Sabzevar University of Medical Sciences

Samples are selected by available sampling method, and after completing the written consent form, they enter the study . Then, for each questionnaire, adjusted according to the demographic and clinical characteristics, it is completed by a evaluator. Samples were randomly assigned to either the intervention or placebo groups based on randomized sequencing. A random sequence will be generated by random four-way blocks.

To duplicate this research, cans containing Handal or placebo capsules is coded by an individual other than the researcher so that the researcher is not aware of the type of supplement received by each group.

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