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Author/year | Phase | Number of patients | Dosage regimen | Findings |
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Trials to assess safety and pharmacokinetics |
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Shoba et al., 1998 [25] | 1 | 10 | Humans: 2 g/day Mice: 2 g/kg | Piperine enhances the serum concentration, absorption, and bioavailability of curcumin in both rats and humans with no adverse effects |
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Chen et al., 2001 [26] | 1 | 25 | 500–12,000 mg/day × 90 days | Histologic improvement of precancerous lesions; seen in 1 out of 2 patients with recently resected bladder cancer, 2 out of 7 patients with oral leukoplakia, 1 out of 6 patients with intestinal metaplasia of the stomach, 1 out of 4 patients with CIN, and 2 out of 6 patients with Bowen’s disease |
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Lao et al., 2006 [27] | 1 | 24 | 500–12,000 mg/day | Curcumin is safe and well tolerated up to 12 g/day |
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Author/year | Disease | Number of patients | Dosage regimen | Findings |
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Trials to assess efficacy in gastrointestinal disease (CRC and IBD)* |
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Sharma et al., 2001 [28] | Colorectal cancer | 15 | 36–180 mg/day × 120 days | Decrease in lymphocytic glutathione S-transferase activity Radiologically stable disease in five patients for 2–4 months of treatment Well tolerated, and dose-limiting toxicity was not observed |
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Sharma et al., 2004 [29] | Colorectal cancer | 15 | 450–3600 mg/day × 120 days | Decrease in inducible PGE(2) production Daily oral dose of 3.6 g of curcumin is advocated for phase II evaluation in the prevention or treatment of cancers outside the gastrointestinal tract |
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Garcea et al., 2004 [30] | Liver metastasis in CRC | 43 | 450–3600 mg/day × 7 day | Poor bioavailability following oral administration |
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Garcea et al., 2005 [31] | CRC | 12 | 450–3600 mg/day × 7 days | Decreased M1G DNA adducts COX-2 levels in malignant colorectal tissue not affected by curcumin |
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Holt et al., 2005 [32] | IBD | 10 | 550 mg; × 2-3/day × 60 days | All proctitis patients improved Reduced concomitant medications in four of five Crohn's disease patients Lowered CDAI scores and sedimentation rates |
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Hanai et al., 2006 [33] | Ulcerative colitis | 89 | 2000 mg/day × 180 days | Maintains remission Improved both CAI (clinical activity index) and EI (endoscopic index) that is Reduced morbidity associated with UC |
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Ongoing trials (http://www.clinicaltrials.gov/) |
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Medical University of Vienna, Department of Clinical Pharmacology [Est. date of completion N/A] | Safety and PK | N/A | Liposomal curcumin; single dose i.v infusion at 10, 20, 40, 80, 120, and 180 mg/m² over 120 minutes | Safety, tolerability, and pharmacokinetics of liposomal curcumin in phase I dose escalation study (i) to evaluate the safety and tolerability of increasing doses of intravenous liposomal curcumin in healthy subjects by means of adverse events, vital signs, and safety laboratory assessments (ii) to investigate the pharmacokinetics of increasing doses of intravenous liposomal curcumin in healthy subjects |
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James Graham Brown Cancer Center, US [Est. Date of completion: Jan, 2013] | Colon cancer | Recruiting | Curcumin: 3.6 g/day × 7 days Curcumin conjugated with plant exosomes tablets × 7 days | Phase I clinical trial investigating the ability of plant exosomes to deliver curcumin to normal and malignant colon tissue (i) to estimate the effect of a fixed concentration of curcumin when delivered by plant exosomes compared to oral tablets of curcumin alone |
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University of Leicester/University Hospitals Leicester, United Kingdom [Est. date of completion date: Jan, 2019] | Colon cancer | Recruiting | | Phase I/II a study combining curcumin (curcumin C3-complex, sabinsa) with standard care FOLFOX chemotherapy in patients with inoperable colorectal cancer (i) Will focus on safety and tolerability (ii) Secondary measurements include efficacy supported by biomarker analysis |
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University of California, Irvine, US [Est date of completion: Dec, 2012] | Colon cancer | Estimated: 48 | | Phase II a trial of curcumin among patients with prevalent subclinical neoplastic lesions (aberrant crypt Foci): (i) Will determine mean percentage change in PGE2 within aberrant crypt foci (ACF) from baseline to 30 days after treatment with curcumin in current smokers. |
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University of North Carolina, Chapel Hill, US [Est. date of completion: March, 2012] | | | 4 grams curcumin C3 tablet daily × 30 days | Chemoprevention of colorectal neoplasia: (i) Use of microarray analysis to identify genes that are modified by curcumin that could be used as biomarkers in future chemoprevention studies (ii) Will also evaluate tolerability and toxicity |
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