A list of clinical trials with curcumin in patients with different diseases

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Disease                                 Dose/Frequency                 Patients         Response                                        Reference

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Safety trials

Phase 1                                                   2000 mg/day1                                          10                            Pipeline enhanced bioavailability by 2000%             Shoba et al,1998

Phase-I                                                    500-12,000 mg/day x 90 days                25                            Histologic improvement of precancerous lesions4   Cheng et al, 2001

Phase 1                                                   500-12,000 mg/day                                 24                            Safe, well-tolerated even at 12 g/day                       Lao et al, 2006

 

Efficacy trials

Rheumatoid arthritis                                1200 mg/day x14 days                           18                            Improved symptoms                                                   Deodhar et al, 1980

Postoperative inflammation                     400 mg; 3 x/day x5 days                        46                            Decrease in inflammation                                           Satoskar  et al, 1986

External cancerous lesions                    1% ointment x several months               62                            Reduction in smell In 90% pts,                                    Kuttan et al, 1987

                                                                                                                                                                Reduction of itching in all cases,

                                                                                                                                                                Dry lesions in 70% pts.

                                                                                                                                                                Reduction in lesion size & pain in 10% pts.

Cardiovascular                                        500 mg/day x 7 days                              10                            Decreased serum lipid peroxidase (33%),                Soni and Kuttan, 1992

                                                                                                                                                                Increased HDL cholesterol (29%),

                                                                                                                                                                Decreased total serum cholesterol (12%)

HIV                                                          625 mg; 4x/day x 56 days                      40                            Well tolerated                                                             James et al,1996

           

Gall bladder function                               20 mg, single dose  (2 h)                        12                            Decreased gall bladder volume                                 Rasyid et al,1999

Chronic anterior uveitis                           375 mg; 3x /day x 84 days                     32                            86% decrease in chronic anterior uveitis                  Lal et al,1999

Psoriasis                                                 1% curcumin gel                                     40                            Decreased PhK2, TRR3, parakeratosis, and             Heng et al, 2000

                                                                                                                                                                density of epidermal CD8+ T cells

Atherosclerosis                                      10 mg; 2x/day x 28 days                        12                            Lowered LDL and apoB,

                                                                                                                                                                Increased HDL and ApoA                                         Ramirez-Bosca et al,2000

Idiopathic Inflammatory Orbital                375 mg; 3x /day x 180-660 days            8                              4 pts recovered completely                                       Lal et al,2000

Pseudotumors                                                                                                                                         1 pt showed decrease in swelling

                                                                                                                                                                No recurrence

 

Colorectal cancer                                    36-180 mg/day x 120 days                     15                            Lowered GST                                                          Sharma et al, 2001

Human gall bladder function                    20-80 mg, single dose (2 hours)             12                            Reduced gall bladder volume by 50%                     Rasyid et al, 2002

Irritable bowel syndrome                        72-144 mg/day x 56 days                       207                          Reduced symptoms                                                  Bundy et al, 2004

Colorectal cancer                                    450-3600 mg/day x 120 days                 15                            Lowered inducible serum PGE2 levels                    Sharma et al, 2004

Liver metastasis from CRC                     450-3600 mg/day x 7 day                       12                            Low bioavailability                                                    Garcea et al, 2004

 

Cadaveric renal transplantation              480 mg; x1-2/day x 30 days                   43                            Induced HO-1 activity                                               Shoskes et al, 2005

                                                                                                                                                                Improved early graft function

Tropical pancreatitis                               500 mg/day x 42 days                             20                            Improved symptoms                                                 Durgaprasad et al, 2005

Inflammatory bowel disease                   550 mg; x 2-3/day x 60 days                  10                            Improved symptoms                                                 Holt et al, 2005

Colorectal cancer                                    450-3600 mg/day x 7 days                     12                            Decreased M1G DNA adducts                                Garcea et al, 2005

 

Ulcerative colitis                                      2000 mg/day x 180 days                        89                            Maintains remission (how many)                             Hanai et al, 2006

Improves cogenitive function                                  -                                              1010                        Better MMSE score5                                                 Ng et al, 2006

Familial adenomatous polyposis              480 mg; x3/day x 180 days                    5                              Reduces polyp numbers and volume                      Cruz-Correa et al, 2006                                                                                                   in FAP patients

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Notes: 1. + Piperine 20 mg/kg; 2, PhK: Phosphorylase kinase; 3.TRR: keratinocyte transferrin receptor ; 4. Histologic improvement of precancerous lesions was seen in 1 out of 2 patients with recently resected bladder cancer, 2 out of 7 patients of oral leucoplakia, 1 out of 6 patients of intestinal metaplasia of the stomach, I out of 4 patients with CIN and 2 out of 6 patients with Bowen's disease; 5. MMSE: Mini-Mental State Examination Score.

 

 

 

 

 

 

 

A list of ongoing clinical trials with curcumin in patients with different diseases

 

                                                                                                               

Disease                Study Type/Design        Patients #         Start Date                               Trial Site

 

Colon cancer                           Phase-I, Randomized                              24                            Completed                                Univ. of Michigan, Ann Arbor, USA

Colorectal cancer, ACF 1        Phase-I, Randomized2                             -                              Suspended                              Rockefeller University Hospital, New York, USA

Colon cancer                           Phase-III, Randomized                            100                          March, 2006                             Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel

Colorectal cancer, ACF1         Phase-II, Non-randomized                      48                            September, 2006                      Univ. of Illinois, Chicago, USA

FAP                                         Phase-II, Randomized4                           68                            July, 2005                                  Univ. of Pennsylvania, Philadelphia, USA

 

FAP                                         Phase-II, Non-randomized                       -                               November, 2005                       Johns Hopkins Univesity, Baltimore, USA

Aberrant crypt foci                 Prevention, Randomized5                        60                         April, 2004                                  Cancer Institute of New Jersey, New Brunswick, USA

Pancreatic cancer                   Phase-II, Non-randomized6                     45                            July, 2004                                 Rambam Medcial Center, Haifa, Israel

Pancreatic cancer                   Phase-II, Non-randomized                       50                            November, 2004                      M.D. Anderson Cancer Center, Houston, USA

Pharmacokinetics                    Treatment, Non-randomized                    6                              August, 2005                           Massachusetts General Hospital, Boston, USA

Myeodysplastic syndrome      Phase II                                                    30                                                                             Univ. Massachusetts, Worcester, USA (Raza A)

 

Alzheimer’s disease               Phase-II, Randomized                              33                            July, 2003                                Univ. of California Los Angeles, Los Angeles, USA

Alzheimer’s disease               Phase-I &II, Randomized7                        30                            Completed                               Chinese University of Hong Kong, Shatin, Hong Kong

Multiple myeloma                     Randomized8                                           30                           November, 2004                      M.D. Anderson Cancer Center, Houston, USA

Myelodysplastic syndrome     Phase-I &II, Non-randomized9                  50                           December, 2006                      Hadassah Medical Organization, Jerusalem, Israel

Psoriasis                                 Phase-II, Non-randomized10                    -                              October, 2005                         Univ. of Pennsylvania, Philadelphia, USA

 

Epilepsy                                   Phase 1                                                   ?                              ?                                              AIIMS, Delhi, India (Gupta YK)

Advanced HNSCC                   Phase II (1-8 g/day; 56 d)                        40                            ?                                              Himalyan Instutute od Medical Sciences, India (Saini S)

HNSCC                                    Phase II/III DBRPC (3.6 g/day,bid)            300                          ?                                              AIIMS, Delhi, India (Bahadur S/Ranju R/Rath GK/Julka PK)               

Cervical cancer (Stage IIb,IIIb)Phase II/III DBRPC (2 g/day,bid, 1 year)   100                          ?                                              AIIMS, Delhi, India (Singh N/Jain SK/Rath GK/Julka PK)            

 

Oral premalignant lesions        Phase II/III DBRPC (4 g/day,bidx 28 d)     90                            ?                                              Tata Memorial Cancer Ctr, India (D’Cruz A)              

Oral premalignant lesions        Phase II/III DBRPC (3.6 g/day,bid)            96                            Nov, 2006                               Amrita Institute, Kochi, India (Kuriakose MA)

Oral leukoplakia                       Phase II (curcumin gel, 3x/day, 6 mo)     100                          ?                                              Regional cancer center, Trivan, India(Ramadas K, Pillai MR)

Gall bladder cancer                 Phase II    (2-8 g/day)                              60                            ?                                              BHU, India (Shukla VK)                                          

Notes: 1. ACF; Abrerrant  crypt foci

Trials were performed with curcumin in combination with 2. Quercetin2, sulindac; 2. Celecoxoib; 3. ACF; 4. Curcuminoids; 5. NSAIDs; 6. Gemcitabine; 6. Ginkgo extract; 7. Bioperine; 8. Coenzyme Q10; 10. Curcuminoids C3 complex; DBRPC, Double blind, randomized placebo-controlled