Evaluation of the efficacy of gel and aqueous extract of Citrullus colocynthis (L.) Schrad in patients with type 2 diabetes compared to placebo gel

Evaluation of the efficacy of gel and aqueous extract of Citrullus colocynthis (L.) Schrad in patients with type 2 diabetes referring to Kerman diabetes clinic

Randomized clinical trial, double blinded, control by placebo In this study, 84 patients with type 2 diabetes (in two groups of 42 people) who are willing to cooperate in the project and have criteria for entry into the study, constitute the target community. It is explained the study schedule to all participants. Patients refer to respectively according to inclusion criteria. Each patient consumes three metformin daily for two weeks and after receiving consent based on their inclusion in the study and the method of balanced block randomization with three blocks are divided into three groups.

1. Preparation of aqueous seed extract and pulp of Citrullus colocynthis (L.) Schrad 2. Gel formulation of aqueous seed extract and pulp Citrullus colocynthis (L.) Schrad 3. Preparation of placebo gel 4. Measurement and comparison of fasting blood glucose / 2 h glucose / insulin in three groups 5. Measurement and comparison of serum levels of creatinine, TG, cholesterol, HDL, SGOT, SGPT, ALP and Bilirubin in the three groups. 6. Determination and comparison of CBC, U/A, PT, PTT and HbA1C in the three groups The project is performed at Physiology and Neuroscience Research Center of Kerman University of Medical Sciences.

Newly diagnosed patients with type 2 diabetes are based on the ADA 2011 criteria, including the age range of between 18-75 years, and there are no restrictions on the sex that they are treated with oral metformin. Exit criteria for diabetic patients include fasting blood glucose greater than 250 and hemoglobin A1C greater than 9%, insulin therapy, chronic inflammatory disease, chronic complications of diabetes, pregnancy, breast feeding, liver, renal and neurological diseases.

Control group: (metformin and placebo gel) Intervention group: In one group, the appropriate amount of formulated gel in carboxymethyl cellulose (5%) is applied on the forearm with area 20 cm2 per day for 30 minutes. in the second group the aqueous extract is used in the traditional method.

FBS; 2 Hpp; Urea; Creatinine; SGOT; SGPT; ALP; Bilirubin; HbA1c; PT; PTT

After obtaining patient's consent, the patients were classified into three groups according to inclusions criteria for study and balanced block randomization with triplex blocks. In one group, the appropriate amount of formulated gel in carboxymethyl cellulose (5%) is rubbed on the forearm with area 20 cm2 per day for 30 min. In the second group, the aqueous extract is used in a traditional method and the third group receives the placebo.

For blinded-experiment, the groups are classified by the Research Center's expert that is not involved in the implementation of the project. This category preserved in the dark package envelope until the end of the design and final analysis at the research center. According to the traditional method group, there is no possibility of blindness for the physician and the patient, but the statistician is blind to the groups.