Clinical Trials
Familial Adenomatous Polyposis (FAP) is an autosomal-dominant disorder characterized by hundreds of colorectal adenomas that eventually develop into colon cancer. The number (60.4%) and size (50.9%) of polyps had decreased after 6 months of combination treatment without any appreciable toxicity in all the clinical trial patients.
Reference: Combination treatment with curcumin and quercetin of adenomas in familial adenomatous polyposis. Clin Gastroenterol Hepatol. 2006;4(8):1035–1038. doi:10.1016/j.cgh.2006.03.020 (www.cghjournal.org/article/S1542-3565(06)00278-3/abstract)
Prostate-Specific Antigen (PSA) Test. An elevated level of PSA per se reflects the risk of developing prostate cancer. Thus, intervention to improve the PSA level may help prevent prostate cancer. A randomized, double-blind, controlled study evaluated the effects of curcumin and soy isoflavones - PSA dropped from 20 ng/ml to 10 ng/ml after 6-month treatment.
Reference: Ide H, Tokiwa S, Sakamaki K, Nishio K, Isotani S, Muto S, et al. Combined inhibitory effects of soy isoflavones and curcumin on the production of prostate-specific antigen. Prostate. 2010;70(10):1127–1133. doi: 10.1002/pros.21147.
Smoke & Lung: Smokers excrete significant amounts of mutagens in the urine and are at high risk of developing lung cancer. In a clinical trial, curcumin significantly reduced the urinary excretion of mutagens in the smokers, but in the control group, no changes in the urinary excretion of mutagens were observed. Curcumin can act as an effective anti-mutagen in smokers and may reduce the risk of lung cancer.
Reference: 25. Polasa K, Raghuram TC, Krishna TP, Krishnaswamy K. Effect of turmeric on urinary mutagens in smokers. Mutagenesis. 1992;7(2):107–109. doi: 10.1093/mutage/7.2.107. (http://www.ncbi.nlm.nih.gov/pubmed/1579064)
Irritable Bowel Syndrome (IrBS) is a chronic problem of the large intestine. The most common symptoms of IrBS are cramping, abdominal pain, bloating, gas, diarrhea, and constipation, and there is no commonly accepted cure. In a clinical trial, taking curcumin for 8 weeks, IrBS prevalence decreased and was reduced 60%. Post-study analysis revealed abdominal pain/discomfort score reduced significantly by 25%. There were significant improvements in the IBSQOL scales of between 5% and 36%.
Reference: Bundy R, Walker AF, Middleton RW, Booth J. Turmeric extract may improve irritable bowel syndrome symptomology in otherwise healthy adults: a pilot study. J Altern Complement Med. 2004;10(6):1015–1018. doi: 10.1089/acm.2004.10.1015. (http://www.ncbi.nlm.nih.gov/pubmed/15673996)
Rheumatoid Arthritis (RA): NSAIDs are used for the treatment of osteoarthritis. The use of NSAIDs, however, is associated with numerous adverse effects. In a clinical trial, 45 patients diagnosed with RA were randomized into three groups with patients receiving curcumin (500 mg) and diclofenac sodium (50 mg) alone or their combination. At endpoints, based on American College of Rheumatology's (ACR) criteria for reduction in tenderness and swelling of joint scores - patients in all three treatment groups showed statistically significant changes in their DAS scores. Interestingly, the curcumin group showed the highest percentage of improvement in overall DAS and ACR scores (ACR 20, 50 and 70) and these scores were significantly better than the patients in the diclofenac sodium group. More importantly, curcumin treatment was found to be safe and did not relate with any adverse events.
Reference: A randomized, pilot study to assess the efficacy and safety of curcumin in patients with active rheumatoid arthritis. Chandran B, Goel A. Phytother Res. 2012 Nov; 26(11):1719-25. (http://www.ncbi.nlm.nih.gov/pubmed/22407780/)
Peptic Ulcer: In a Phase II clinical trial, the results after 4 weeks of taking turmeric showed that ulcers were absent in 48% or 12 cases (DU 9 and GU 3). Eighteen cases or 60% (DU 13 and GU 5) had absence of ulcers after 8 weeks, and nineteen cases (76%) (DU 14 and GU 5) did not have ulcers after 12 weeks of treatment.
Reference: Phase II clinical trial on effect of the long turmeric (Curcuma longa Linn) on healing of peptic ulcer. Southeast Asian J Trop Med Public Health. 2001 Mar; 32(1):208-15. (http://www.ncbi.nlm.nih.gov/pubmed/11485087/)
Ulcerative Colitis: In a multi-center randomized, placebo-controlled double-blind study, patients were randomly assigned to groups and given curcumin capsules (3g/day, n=26) or an identical placebo (n=24) for 1 month. 14 patients (53.8%) receiving curcumin achieved clinical remission at week 4 compared to none of the patients receiving placebo. Clinical response (reduction of ≥3 points in SCCAI) was achieved by 17 patients (65.3%) in the curcumin group vs. 3 patients (12.5%) in the placebo group. Endoscopic remission (partial Mayo score ≤1) was observed in 8 out of the 22 patients evaluated in the curcumin group (38%), compared with none of 16 patients evaluated in the placebo group. Adverse events were rare and comparable between the 2 groups.
Reference: Curcumin in Combination With 5-aminosalycilate Induces Remission in Patients with Mild to Moderate Ulcerative Colitis in a Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2015 Feb 24. pii: S1542-3565(15)00158-5. doi: 10.1016/j.cgh.2015.02.019. (www.ncbi.nlm.nih.gov/pubmed/25724700)
Atherosclerosis is a condition in which fatty materials such as cholesterol accumulates and thickens in the artery wall. The effect of curcumin administration in reducing the serum levels of cholesterol and lipid peroxides was studied in ten healthy human volunteers receiving 500 mg of curcumin per day for 7 days. A significant decrease in the level of serum lipid peroxides (33%), an increase in HDL Cholesterol (29%), and a decrease in total serum cholesterol (11.63%) were noted.
Reference: Effect of oral curcumin administration on serum peroxides and cholesterol levels in human volunteers. Indian J Physiol Pharmacol. 1992 Oct;36(4):273-5. (http://www.ncbi.nlm.nih.gov/pubmed/1291482/)
Atherosclerosis: In an animal study, curcumin was consumed at 0.2% (wt/wt) in the diet for 4 months. This supplementation reduced the extent of atherosclerotic lesion by 26% and induced changes in expression of genes implicated in cell adhesion and transendothelial migration or cytoskeleton organization, as revealed by a transcriptomic analysis in the aorta. Expression profile of these genes suggests reduction in both leukocyte adhesion and transendothelial migration.
Reference: Dietary curcumin inhibits atherosclerosis by affecting the expression of genes involved in leukocyte adhesion and transendothelial migration. Mol Nutr Food Res. 2012 Aug;56(8):1270-81. doi: 10.1002/mnfr.201100818. Epub 2012 Jul 2. (http://www.ncbi.nlm.nih.gov/pubmed/?term=Dietary+curcumin+inhibits+atherosclerosis+by+affecting+the+expression+of+genes+involved
+in+leukocyte+adhesion+and+transendothelial+migration)
Diabetes: In a randomized, double-blinded, placebo- controlled trial, after 9 months of curcumin treatment - 16.4% of participants in the placebo group were diagnosed with type 2 diabetes, whereas none were diagnosed with type 2 diabetes in the curcumin-treated group. In addition, the participants of the curcumin-treated group showed a better overall function of β cells, with higher HOMA-β and lower C-peptide levels.
Reference: Curcumin extract for prevention of type 2 diabetes. Diabetes Care. 2012 Nov;35(11):2121-7. doi: 10.2337/dc12-0116. Epub 2012 Jul 6. (http://www.ncbi.nlm.nih.gov/pubmed/22773702/)
Type 2 Diabetic Nephropathy (Kidney failure): Proteinuria and TGF-β may contribute to the development of end-stage renal disease in patients with diabetic nephropathy. In a randomized, double-blind and placebo-controlled study, after taking curcumin for 2 months - serum concentrations of TGF-β and IL-8, and urinary protein excretion and IL-8, were significantly decreased after curcumin supplementation in comparison with the pre-supplementation values. No adverse effects related to curcumin supplementation were observed during the trial. Supplementation can attenuate proteinuria, TGF-β, and IL-8 in patients with overt type 2 diabetic nephropathy and can be administered as a safe adjuvant therapy for these patients.
Reference: Oral supplementation of turmeric attenuates proteinuria, transforming growth factor-β and interleukin-8 levels in patients with overt type 2 diabetic nephropathy: a randomized, double-blind and placebo-controlled study. Scand J Urol Nephrol. 2011 Nov;45(5):365-70. doi: 10.3109/00365599.2011.585622. Epub 2011 May 31. (http://www.ncbi.nlm.nih.gov/pubmed/21627399/)
Lupus Nephritis: A randomized and placebo-controlled study was carried out. Each patient in the trial group received curcumin supplements for 3 months. A significant decrease in proteinuria was found when comparing pre (954.2 ± 836.6) and 1, 2, and 3 months supplementation values (448.8 ± 633.5, 235.9 ± 290.1, and 260.9 ± 106.2, respectively) in the trial group. Also, systolic blood pressure and hematuria were found to decrease significantly. No adverse effect related to curcumin supplementation was observed during the trial.
Reference: Oral supplementation of turmeric decreases proteinuria, hematuria, and systolic blood pressure in patients suffering from relapsing or refractory lupus nephritis: a randomized and placebo-controlled study. J Ren Nutr. 2012 Jan;22(1):50-7. doi: 10.1053/j.jrn.2011.03.002. Epub 2011 Jul 13. (http://www.ncbi.nlm.nih.gov/pubmed/21742514/)
Rheumatoid Arthritis: In another randomized pilot study, the efficacy of curcumin alone and in combination with diclofenac sodium was assessed in patients with active RA. The 45 patients diagnosed as having RA were randomized into three groups. The primary end points were reduction in Disease Activity Score (DAS) 28. The secondary end points included American College of Rheumatology (ACR) criteria for reduction in tenderness and swelling of joint scores. Patients in the curcumin group showed the highest percentage of improvement in overall DAS and ACR scores, which were significantly better than those of patients in the diclofenac sodium group. To our knowledge, this is the first evidence showing the potential of curcumin as a therapeutic for patients with active RA.
Reference: A Randomized, Pilot Study to Assess the Efficacy and Safety of Curcumin in Patients with Active Rheumatoid Arthritis DOI: 10.1002/ptr.4639 (http://onlinelibrary.wiley.com/doi/10.1002/ptr.4639/abstract)
Knee Osteoarthritis: A pilot, randomized, double-blind, placebo-control parallel-group clinical trial was conducted in knee OA. Patients were assigned to curcuminoids (1500 mg/day in 3 divided doses; n = 19) for 6 weeks. Efficacy measures were changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), visual analogue scale (VAS) and Lequesne's pain functional index (LPFI) scores during the study. Treatment with curcuminoids was associated with significantly greater reductions in WOMAC (p = 0.001), VAS (p < 0.001) and LPFI (p = 0.013) scores compared with placebo. There was no considerable adverse effect in both groups. To conclude, curcuminoids represent an effective and safe alternative treatment for OA.
Reference: Curcuminoid Treatment for Knee Osteoarthritis: A Randomized Double-Blind Placebo-Controlled Trial. 22 MAY 2014, DOI: 10.1002/ptr.5174. (http://onlinelibrary.wiley.com/doi/10.1002/ptr.5174/abstract)
Alzheimer's Disease (AD): An animal study demonstrated that administration of curcumin was effective in preventing behavioral impairments, neuroinflammation, tau hyperphosphorylation as well as cell signaling disturbances triggered by Aβ in vivo. Of high interest, nano encapsulated curcumin in a dose 20-folds lower presented similar neuroprotective results compared to the effective dose of free curcumin. Considered overall, the data suggests that curcumin is a potential therapeutic agent for neurocognition, and nano encapsulation of curcumin might constitute a promising therapeutic alternative in the treatment of neurodegenerative diseases such as Alzheimer's disease AD.
Reference: Free and nano encapsulated curcumin suppress β-amyloid-induced cognitive impairments in rats: involvement of BDNF and Akt/GSK-3β signaling pathway. Neurobiol Learn Mem. 2013 Nov;106:134-44. doi: 10.1016/j.nlm.2013.08.001. Epub 2013 Aug 14. (http://www.ncbi.nlm.nih.gov/pubmed/23954730)
Dementia & Age-Related Cognitive Decline: In a randomized, double-blind, placebo-controlled trial, curcumin significantly improved performance on sustained attention and working memory tasks, compared with placebo. Working memory and mood were significantly better following chronic treatment. A significant acute-on-chronic treatment effect on alertness and contentedness was also observed. Curcumin was associated with significantly reduced total and LDL cholesterol and had no effect on hematological safety measures. This trial shows that curcumin possesses many properties which may prevent or ameliorate pathological processes underlying age-related cognitive decline, dementia or mood disorders.
Reference: Investigation of the effects of solid lipid curcumin on cognition and mood in a healthy older population. J Psychopharmacol. 2014 Oct 2. pii: 0269881114552744. (https://www.ncbi.nlm.nih.gov/pubmed/25277322)
Depression: In a randomized, double-blind, placebo-controlled study, 56 individuals with major depressive disorder were treated with curcumin (500 mg twice daily) or placebo for 8 weeks. From weeks 4 to 8, curcumin was significantly more effective than placebo in improving several mood-related symptoms - demonstrated by a significant group x time interaction for IDS-SR30 total score (F1, 53=4.22, p=.045) and IDS-SR30 mood score (F1, 53=6.51, p=.014), and a non-significant trend for STAI trait score (F1, 48=2.86, p=.097). Greater efficacy from curcumin treatment was identified in a subgroup of individuals with atypical depression. Partial support is provided for the antidepressant effects of curcumin in people with major depressive disorder, evidenced by benefits occurring 4 to 8 weeks after treatment.
Reference: Curcumin for the treatment of major depression: a randomized, double-blind, placebo controlled study. J Affect Disord. 2014;167:368-75. doi: 10.1016/j.jad.2014.06.001. Epub 2014 Jun 11. (http://www.ncbi.nlm.nih.gov/pubmed/25046624)
Depression: Current medications have limited efficacy in controlling the symptoms of major depressive disorder (MDD), and are associated with several adverse events on long-term use. 111 subjects were assigned to standard antidepressive therapy plus curcuminoids-piperine combination (1000-10 mg/day; n=61) or standard antidepressive therapy alone (n=50) for a period of 6 weeks. There were significantly greater reductions in total HADS score and subscales of anxiety and depression in the curcuminoids versus control group (p<0.001). Likewise, reductions in BDI-II total score and scores of somatic and cognitive subscales were found to be greater in the curcuminoids compared with control group (p<0.001). Co-administration of curcuminoids with piperine may be used as a safe and effective add-on to standard antidepressants in patients with MDD.
Reference: Investigation of the efficacy of adjunctive therapy with bioavailability-boosted curcuminoids in major depressive disorder. Phytother Res. 2015 Jan;29(1):17-21. doi: 10.1002/ptr.5211. Epub 2014 Aug 4. (http://www.ncbi.nlm.nih.gov/pubmed/25091591)
Erectile Dysfunction(ED): In an animal trial on diabetes ED mice, curcumin or its combination with sildenafil (Vigra) showed significant efficacy enhanced erectile function and more prolonged duration of action in a diabetes mice. Administration of all therapeutic interventions led to a significant elevation in intracavernosal pressure ICP, cGMP levels, increase in HO-1 and NOS enzymes, HO-1 and Nrf2 gene expression, and a significant decrease in NF-κβ, p38 gene expression. In conclusion, curcumin could enhance erectile function with more efficacy and more prolonged duration of action.
Reference: Efficacy of a novel water-soluble curcumin derivative versus sildenafil citrate in mediating erectile function. Int J Impot Res. 2015 Jan-Feb;27(1):9-15. doi: 10.1038/ijir.2014.24. Epub 2014 Aug (http://www.ncbi.nlm.nih.gov/pubmed/25099638)
Artery Stiffening & Endothelial Dysfunction: An animal study provided the first evidence that dietary curcumin supplementation ameliorates two clinically important markers of arterial dysfunction with aging: large elastic artery stiffening and endothelial dysfunction. Moreover, curcumin normalization of vascular superoxide production and oxidative stress, reductions in collagen I and aging in the arterial wall, and restoration of bioavailability. Given its accessibility and safety, these pre-clinical findings provide the experimental basis studies assessing the potential for curcumin to treat arterial dysfunction with aging and reduced heart attack risk in humans.
Reference: Curcumin Ameliorates Arterial Dysfunction and Oxidative Stress with Aging. Exp Gerontol. 2013 February ; 48(2): 269–276. doi:10.1016/j.exger.2012.10.008. (http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3557759/)
Heart Dysfunction: Animal studies showed a promising role of curcumin as a cardioprotective agent against palmitate and high fat diet mediated cardiac dysfunction. Oral administration of curcumin at 50mg/kg completely suppressed high fat diet-induced oxidative stress, inflammation, apoptosis, fibrosis, hypertrophy and tissue remodeling in mice.
Reference: Curcumin protects hearts from FFA-induced injury by activating Nrf2 and inactivating NF-κB both in vitro and in vivo. J Mol Cell Cardiol. 2015 Feb;79:1-12. doi: 10.1016/j.yjmcc.2014.10.002. Epub 2014 Oct 16. (http://www.ncbi.nlm.nih.gov/pubmed/25444713)
Biliary Dyskinesia is a motility disorder that affects the gallbladder and sphincter of Oddi. The disease is often associated with right upper abdominal pain. A multicenter pilot study analyzed the effects of dried Curcuma extracts on abdominal pain in the right upper quadrant due to biliary dyskinesia (68). The extract was given to 39 patients and placebo to 37 patients for 3 weeks. Pain reduction was more rapid during the first treatment week in patients who received the extract than in the control group. Secondary variables such as food intolerance, nausea, vomiting, and meteorism were also improved in the extract-treated patients during the whole treatment period, and the extract was not associated with any adverse effects.
Reference: The effect of chelidonium- and turmeric root extract on upper abdominal pain due to functional disorders of the biliary system. Results from a placebo-controlled double-blind study. Med Klin (Munich). 1999 Aug 15;94(8):425-30. (http://www.ncbi.nlm.nih.gov/pubmed/10495621/)
Premenstrual Syndrome Symptoms: In a clinical trial, double-blinded study, after having identified persons suffering from PMS, participants were randomly allocated to received two curcumin capsules daily for seven days before menstruation and for three days after menstruation for three successive cycles, total severity of PMS score had reduced from 102.06±39.64 to 42.47±16.37 (mean change: 59.59; 95% confidence interval.)
Reference: Curcumin attenuates severity of premenstrual syndrome symptoms: A randomized, double-blind, placebo-controlled trial. Complement Ther Med. 2015 Jun;23(3):318-24. doi: 10.1016/j.ctim.2015.04.001. Epub 2015 Apr 9. (http://www.ncbi.nlm.nih.gov/pubmed/?term=curcumin+and+premenstrual+syndrome)