Health Condition 1: E133- Other specified diabetes mellituswith ophthalmic complications
Conditions
Interventions
Intervention1: IXAN DR Tablet containing Curcuminoids 120mg, Lutein 20mg, Trans Zeaxanthin 2.0 mg, Licorice 25 mg,Alpha lipoic acid 25mg, Bilberry extract 50 mg and Zinc 13 mg: Dose:800 mg Dosa
Sponsors
FF Bioworks (India) Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female, 18 70 years 2. Diagnosed with Type 2 Diabetes Mellitus Presence of mild to severe non-proliferative diabetic retinopathy (NPDR) in at least one eye, classified by ETDRS scale: I. Mild NPDR (ETDRS level 20) II. Moderate NPDR (ETDRS level 35 43) III. Severe NPDR (ETDRS level upto 55) 3. Confirmed NPDR by fundus photography 4. HbA1c less than or equal to 9 percent 5. Willingness to provide informed consent 6.Willing and able to adhere to the dietary regimen outlined in the study protocol. 7. Willing to attend regular follow-up visits as specified in the study protocol.
Exclusion criteria
Exclusion criteria: 1. Presence of Proliferative diabetic retinopathy (PDR) in either eye. 2. Co-existing eye diseases that may affect vision (e.g., glaucoma, retinal vein occlusion, AMD). 3. Intravitreal anti-VEGF or corticosteroid therapy in the study eye. 4. Previous Vitreoretinal surgery 5. Other Intraocular surgery in the study eye within the past 3 months (e.g., Cataract surgery, Glaucoma surgery, Secondary IOL implantation) 6. Uncontrolled hypertension, severe renal disease (e.g., on dialysis), or recent major cardiovascular event. 7. Pregnant or breastfeeding women 8. Participation in another interventional clinical trial within 30 days. 9. Any condition that may interfere with follow-up or treatment compliance. 10. Current use of systemic or ocular steroids 11. Use of any similar nutraceutical supplements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Proportion of patients with progression from mild/moderate to severe NPDR (As per ETDRS scale) 2.To evaluate changes OCTA (dye-less angiography) Timepoint: Screening/Baseline, Day 60, Day 120, Day 180 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes 1. Change in central retinal thickness (assessed by OCT) 2. Change in visual acuity (ETDRS letters) 3. Change in glycemia parameters (HbA1c) & glycemic variability 4. Change in renal function (serum creatinine, eGFR, urinary albumin excretion) 5. Change in insulin resistance (estimated glucose disposal rate [eGDR], adiponectin) 6. Change in lipid/lipoprotein profile (lipids, ApoA1, ApoB, AGE-LDL, LDL-immune complexes) 7. Change in nutrition-related markers (Vitamin D, homocysteine) 8. Change in inflammatory markers (WCC, ESR, CRP, adhesion molecules, cytokines, chemokines, transcription factors) 9. Change in oxidative stress markers (oxLDL, isoprostanes) 10. Change in advanced glycation end-products (AGEs, sRAGE) 11. Change in growth factor-related markers (VEGF, PEDF, FGF21)Timepoint: Day 0, Day 60 & Day 180;12. Change in vascular tone markers (Endothelin-1, nitric oxide-related markers, ADMA) 13. Change in thrombosis & fibrinolysis markers (fibrinogen, PAI-1) 14. Change in glycomics (analysis of glucose-modified lipids or proteins) 15. Adverse events (AEs). 16. Abnormal findings in vital signs & medical interviews. 17. Abnormal changes in the hematology, serum biochemistry, & urine analysis results. Timepoint: Day 0, Day 60 & Day 180 | — |
Countries
India
Contacts
Public ContactATJacob
FF Bioworks (India) Pvt Ltd
Outcome results
None listed