Table II.
Ongoing or future randomized clinical trials of curcumin in metabolic syndrome, non-alcoholic fatty liver disease and other liver diseases (from clinicaltrials.gov)
| Name | ClinicalTrials.gov Identifier | Number of patients estimated | Type of patients | Purpose | Study design | Curcumin formulation, treatment schedule and duration |
|---|---|---|---|---|---|---|
| Effects of Short-term Curcumin and Multi-polyphenol Supplementation on the Anti-inflammatory Properties of HDL (PSI) | NCT02998918 | 20 | > 18 and < 60 years old healthy, non-smoker patients | VCAM-1 and ICAM-1 expression in whole plasma and in HDL at baseline, after 1 h and after 1 week of supplementation | (Randomized) cross-over, single blind | PolyResveratol 500 mg (100 mg curcumin phytosome, 100 mg quercetin phytosome, 100 mg green tea phytosome, 100 mg trans-resveratrol, 100 mg trans-pterostilbene) BID for a week versus curcumin phytosome 1 g QD for a week |
| Effect of Oral Supplementation With Curcumin in Patients With Proteinuric Diabetic Kidney Disease | NCT01831193 | 100 | > 18 and < 80, diabetic patients with moderate chronic kidney disease (glomerular filtration rate between 15–60 ml/min/1.73 m2) | Proteinuria, HbA1c, AST, ALT | (Randomized) double-blind, placebo-controlled | 1.67 g of curcumin (7 capsules of 231 mg) divided into 3 doses daily for 6 months |
| Curcumin Supplement in Nonalcoholic Fatty Liver Patients With Type 2 Diabetes | NCT02908152 | 50 | > 30 and < 65 diabetic patients and CAP score > 263 | Hepatic steatosis measured by CAP score using Fibroscan, glucose, HbA1c, AST, ALT | (Randomized), quadruple blind placebo-controlled | Curcumin 1500 mg for 12 weeks QD |
| Effects of Curcumin Supplementation on Lipid Profile and Inflammatory Markers of Patients With Type 2 Diabetes | (NCT02529969) | 50 | > 40 and < 65, diabetic non-insulin dependent patients, BMI < 30 | Triglyceride and C-reactive protein | (Randomized) double blind, placebo-controlled | Curcumin 500 mg for 12 weeks QD |
| A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis | NCT02978339 | 15 | > 18 and < 75, diagnosis of primary sclerosing cholangitis (PSC) | ALP, AST, ALT, GGT, bilirubin, CRP, albumin, Mayo PSC risk score, quality of life | Open-label study | One 750 mg softgel by mouth BID for 12 weeks. Each 750 mg CuraMed softgel supplies 500 mg of highly bioavailable BCM-95 curcumin |
| Effects of Curcumin Supplementation on Glycemic Control, Oxidative Stress, Lipid Profile and Inflammatory Markers of Patients With Type 2 Diabetes | NCT02529982 | 50 | Non-insulin dependent diabetic patients | Fasting blood glucose, total capacity antioxidant | (Randomized) double blind placebo-control | 500 mg curcumin for 12 weeks |
| Micellar Curcumin and Metabolic Syndrome Biomarkers | NCT01925547 | 42 | > 18 years metabolic syndrome | C-reactive protein, AST, ALT, GGT, TNF-α, IL-6, insulin, plasma albumin, serum total cholesterol, triglyceride, cholesterol, blood pressure, body weight | (Randomized) crossover double blind | 80 mg micellar curcumin (oral) TID for 6 weeks |
| Curcumin Therapy in Patients With Impaired Glucose Tolerance and Insulin Resistance | NCT01052025 | 200 | Patients aged 35 years or older with an abnormal fasting plasma glucose (100–125 mg/dl) or with insulin resistance (140–199 mg/dl) by using 75 mg of glucose OGTT | Reduction of blood sugar level, lipid profile, insulin resistance status and oxidative stress status | (Randomized) single blind placebo-control | Curcumin capsule contains 250 mg curcuminoids, 3 capsules per time, 2 times a day before meal for 12 months |
AST – aspartate aminotransferase, ALT – alanine aminotransferase, GGT – γ-glutamyl transpeptidase, NAFLD – non-alcoholic fatty liver disease, QD – quaque die (once a day), BID – bis in die (twice a day), TID – tris in die (three times a day).