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Last Updated: October 19, 2019

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CLINICAL TRIALS PROFILE FOR SAFFLOWER OIL

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Clinical Trials for Safflower Oil

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004420 Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis Completed University of Massachusetts, Worcester N/A 1994-09-01 OBJECTIVES: I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.
NCT00004420 Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis Completed FDA Office of Orphan Products Development N/A 1994-09-01 OBJECTIVES: I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.
NCT00396461 ICULIP, Influence of Two Lipid Emulsions in the Nosocomial Infection in Critical Patients Terminated B. Braun Medical SA Phase 4 2006-11-01 This study aims to analyse the effect of two total parenteral nutrition diets with lipid emulsions of different compositions on the incidence of nosocomial infection in critical patients. One diet will contain an MCT/LCT emulsion concentrated to 20% (50:50 ratio) and the other will comprise an MCT/LCT/fish oil emulsion (50:40:10 ratio). The secondary objective of this study is to analyse mortality in hospital and up to 6 months of discharge.
NCT00682318 Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers Recruiting American Heart Association N/A 2008-05-01 The American Heart Association and the American College of Cardiology (AHA/ACC) recently encouraged "increased consumption of omega-3 fatty acids in the form of fish or capsule form (1 g/day) for risk reduction" and stated that "for treatment of elevated triglycerides, higher doses are usually necessary for risk reduction" (Smith SC et al. Circulation 2006;113:2363-72). These recommendations are based on conflicting evidence about the efficacy of the omega-3 treatment with data derived from single randomized trials or non-randomized studies (Smith SC et al. Circulation 2006;113:2363-72). Much effort has been undertaken to elucidate the role of omega-3 fatty acids in the development of cardiovascular disease, but even recent meta-analyses deliver no clear picture; they either favor (Mozaffarian D Jama 2006;296:1885-99) or reject (Hooper L Bmj 2006;332:752-60) the hypothesis of cardioprotective effects of omega-3 FAs. The objective of the clinical study is to study the effects of fish oil on blood and urinary markers of inflammation and cell stress. By using different permutations of high-dose supplementation of omega-3 and omega-6 fatty acids versus different alimentary omega-3 fish doses and grain alcohol versus different kinds of red wine, this trial will study how omega-3 fatty acids, ethanol and red wine constituents modulate biomarkers of inflammation and cell stress.
NCT00682318 Effects of Fish Oil and Red Wine on Oxidative Stress Biomarkers Recruiting Carsten Skarke N/A 2008-05-01 The American Heart Association and the American College of Cardiology (AHA/ACC) recently encouraged "increased consumption of omega-3 fatty acids in the form of fish or capsule form (1 g/day) for risk reduction" and stated that "for treatment of elevated triglycerides, higher doses are usually necessary for risk reduction" (Smith SC et al. Circulation 2006;113:2363-72). These recommendations are based on conflicting evidence about the efficacy of the omega-3 treatment with data derived from single randomized trials or non-randomized studies (Smith SC et al. Circulation 2006;113:2363-72). Much effort has been undertaken to elucidate the role of omega-3 fatty acids in the development of cardiovascular disease, but even recent meta-analyses deliver no clear picture; they either favor (Mozaffarian D Jama 2006;296:1885-99) or reject (Hooper L Bmj 2006;332:752-60) the hypothesis of cardioprotective effects of omega-3 FAs. The objective of the clinical study is to study the effects of fish oil on blood and urinary markers of inflammation and cell stress. By using different permutations of high-dose supplementation of omega-3 and omega-6 fatty acids versus different alimentary omega-3 fish doses and grain alcohol versus different kinds of red wine, this trial will study how omega-3 fatty acids, ethanol and red wine constituents modulate biomarkers of inflammation and cell stress.
NCT01000714 Determination of the Efficacy and Safety of Psirelax in the Relief of the Disease in Psoriasis Completed Etwal Ltd. Phase 2 1969-12-31 Psoriasis is a chronic disorder characterized by erythematous scaly patches which affect the scalp, trunk, extensor surfaces of the limbs and the genital area. The common form of psoriasis is referred to as psoriasis vulgaris. There are several variants of psoriasis such as guttate psoriasis, inverse psoriasis, pustular psoriasis and erythrodermic psoriasis. Psoriasis is highly prevalent in the general population, mainly as a result of its chronicity and the absence of a cure. The estimates of psoriasis prevalence are within the range of 0.5% to 4%. The diagnosis of psoriasis is made on a clinical base, usually by physical examination, performed by a dermatologist. Although skin biopsy may be useful in some cases, there is no laboratory test which may serve as a reference standard to the clinical diagnosis of psoriasis. Psoriasis in its mild cases per se is not associated with excess mortality, however, the disease may affect quality of life of affected patients to a substantial degree. Psoriasis may be readily apparent to others because of scales and redness of the skin. The skin may itch and scales may shed from the patients to the environment or directly on other people. Feelings of stigmatization and major changes in life-style caused by psoriasis have been documented in numerous studies. The burden of the disease may be exaggerated due to expensive therapy and complicated therapeutic regimes Patients with mild to moderate psoriasis are usually treated with topical treatments. Photo-therapy or systemic treatments are reserved to patients with moderate to severe disease. Topical corticosteroids may lead to rapid improvement in psoriasis, however rapid relapse following discontinuation is the common practice leading to chronic use. Calcipotriene ointment may also be used and requires 8 to 12 weeks of use for maximal effect and often causes local irritation, particularly when used on the face. The use is limited to 100 gr/week due to hypercalcemia that might follow systemic absorption. Vitamin A derivative tazarotene may be also be used for plaque psoriasis. Although it can produce longer remissions than topical steroids, local irritation, cost, and teratogenicity limit its use. Coal tar products may be used as steroid-sparing agents, especially useful for enhancing the efficacy of natural sunlight and phototherapy. Application can be cumbersome because of irritation, unpleasant smell, brown color that can stain clothing, and propensity to cause folliculitis. All of the above treatments are particularly problematic for the face and genital psoriasis due to the potential side effects and mainly possible severe irritation reducing patients compliance. Psirelax is a novel topical medication directed for the treatment of patients with psoriasis. The formulation of Psirelax includes the following substances: 5%-15% quince seeds jelly, 10%-40% natural base cream (e.g. Ferntree Cottage Pure Base Cream), 55%-75% mixture of natural anti-oxidants (e.g. Vitamin E, wheat germ oil, Safflower oil), natural skin softening agents (e.g. sweet almond oil, sesame oil), natural absorption aids (e.g. jojoba oil, vegetable squalene), natural tissue regenerating and protecting agents (e.g. grape seed oil, sunflower oil), natural preservatives (e.g. paraben, tea trea essential oil, thyme essential oil, grapefruit seed extract, Vitamin E) and natural thickening agents (e.g. bee wax, aloevera, medicinal Vaseline, coconut oil, guar gum, palm oil, borax) In a preliminary observation, a patient with severe psoriasis applied Psirelax three times each day during four days. The patient reported complete disappearance of the psoriatic plaques and pruritus was reduced by 70%. It was suggested to conduct an open study to assess the effect of Psirelax in patients with psoriasis vulgaris. The aim of this study is to examine the safety and efficacy of Psirelax in the treatment of psoriasis.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Safflower Oil

Condition Name

Condition Name for Safflower Oil
Intervention Trials
Vascular Dementia 2
Glycogen Storage Disease Type V 2
Critical Illness 1
Cholestasis 1
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Condition MeSH

Condition MeSH for Safflower Oil
Intervention Trials
Metabolic Diseases 2
Cholestasis 2
Glycogen Storage Disease Type V 2
Glycogen Storage Disease 2
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Clinical Trial Locations for Safflower Oil

Trials by Country

Trials by Country for Safflower Oil
Location Trials
China 11
Spain 8
United States 4
Israel 1
Denmark 1
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Trials by US State

Trials by US State for Safflower Oil
Location Trials
California 1
Pennsylvania 1
North Carolina 1
Missouri 1
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Clinical Trial Progress for Safflower Oil

Clinical Trial Phase

Clinical Trial Phase for Safflower Oil
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
Phase 2 5
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Clinical Trial Status

Clinical Trial Status for Safflower Oil
Clinical Trial Phase Trials
Completed 2
Unknown status 2
Not yet recruiting 2
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Clinical Trial Sponsors for Safflower Oil

Sponsor Name

Sponsor Name for Safflower Oil
Sponsor Trials
Rigshospitalet, Denmark 2
Shineway Pharmaceutical Co.,Ltd 2
Institut National de la Santé Et de la Recherche Médicale, France 1
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Sponsor Type

Sponsor Type for Safflower Oil
Sponsor Trials
Other 11
Industry 4
U.S. Fed 1
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