Effect of curcumin piperine in patients with non-proliferative diabetic retinopathy

Phase 2

Conditions: Diabetic retinopathy.
Diabetes mellitus due to underlying condition with ophthalmic complications
E08.3

Registration Number: IRCT20201129049534N5

Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 50

Inclusion Criteria

Age 30 to 65 years
Diagnosis of diabetic retinopathy with the approval of an ophthalmologist, imaging, CT scan or PCR
Definitive diagnosis of diabetes by a diabetic doctor (fasting blood sugar above 126 mg / dL measured twice or HbA1C greater than or equal to 6/5%)

Exclusion Criteria

Sensitivity to plant products such as turmeric and pepper
Follow a special diet in the last 3 months
Taking anticoagulants such as heparin, warfarin, aspirin, etc.
Pregnancy and lactation
Patient dissatisfaction
Taking herbal medicines or supplements in the last 3 months
Requires the use of anti-VEGF (Anti–vascular endothelial growth factor)
Use of therapies including laser therapy, surgery and intraocular injections
Having certain diseases such as congenital diseases, type 1 diabetes, immune deficiency, cancer
Uncontrolled diabetes
Consume less than 80% of the curcumin piperine supplement
Report any adverse side effects after taking supplements
If other treatments of the patient such as treatment of hypertension, hyperlipidemia, etc. are variable during the course of treatment.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Macular artery density. Timepoint: At baseline and end of the study. Method of measurement: OCTA (Optical Coherence Tomography angiography) device.;C reactive Protein (CRP). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Superoxide dismutase. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;Total antioxidant capacity. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.;Fasting blood sugar. Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Triglycerides. Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Malondialdehyde. Timepoint: At baseline and end of the study. Method of measurement: Commercial diagnostic kit.

Secondary Outcome Measures

Name	Time	Method
Blood urea nitrogen (BUN). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Creatinine (Cr). Timepoint: At baseline and end of the study. Method of measurement: ELISA test.;Sleep Quality. Timepoint: At baseline and end of the study. Method of measurement: Pittsburgh sleep quality index (PSQI) questionnaire.;Emotional status (stress, anxiety, and depression). Timepoint: At baseline and end of the study. Method of measurement: DASS-21 questionnaire.;Weight. Timepoint: At baseline and end of the study. Method of measurement: Digital Scale.