Effects of lemon balm extract on depression, anxiety, sleep quality and hs-CRP in comparison with control group in patients with type II diabetes and depressio

Not Applicable

Recruiting

Conditions: Type 2 diabetes mellitus.
Non-insulin-dependent diabetes mellitus
E10, E11,

Registration Number: IRCT201709239472N16

Lead Sponsor: private

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Inclusion criteria are: getting at least 11 scores in the Beck Depression Inventory (BDI-II); Patients aged 20 to 65 years for both sexes; The body mass index less than 35 kg/m2; no pregnancy or lactation; triglycerides less than 400 mg/dl; HbA1c < % 8; using a common diabetes drug (metformin and glibenclamide). Exclusion criteria are: Lack of any co-disorders including cardiovascular, liver, renal, allergic and infectious diseases as well as thyroid disorders and glaucoma; taking non steroidal anti-inflammatory drugs (NSAIDS), anti depression or estrogen and progesterone.

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep quality. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Pittsburgh Sleep Quality Index.;Depression. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Beck Depression Questionnaire.;FBS. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Enzymatic method.;Hs-CRP. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: ELISA.;Anxiety. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Beck Anxiety Questionnaire.

Secondary Outcome Measures

Name	Time	Method
BP. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Digital sphygmomanometer.;Body mass index. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Weight (kg) /height2 (m2).;Weight. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Seca scale.;Waist circumference. Timepoint: Before the experiment and 12 weeks after intervention. Method of measurement: Elastic tape.;Physical activity. Timepoint: Before intervention and 6 and 12 weeks after intervention. Method of measurement: International Physical Activity Questionarre.;Energy intake. Timepoint: Before intervention and 6 and 12 weeks after intervention. Method of measurement: 24-hour dietary recall.