Alzer® and Diamel® to Prevent Severe Diabetes Macular Edema

Tylko zarejestrowani użytkownicy mogą tłumaczyć artykuły

Zaloguj się Zarejestruj się

Link zostanie zapisany w schowku

StatusZakończony

Sponsorzy

Catalysis SL

BADANIE KLINICZNE: NCT03533478

BioSeek: NCT03533478

Słowa kluczowe

Abstrakcyjny

Macular edema is the main cause of low vision in diabetics. They continue looking for new treatment alternatives. The nutritional supplement Alzer, is a powerful antioxidant that together with Diamel, a supplement that has shown efficacy in metabolic control, could be a therapeutic option. Objective: To evaluate the therapeutic efficacy of the Alzer Diamel combination in mild and moderate macular edema. Material and method: A randomized double-blind phase II clinical trial versus placebo will be conducted in 64 patients, who will be randomly assigned to two groups, one will receive Alzer + Diamel and another will receive placebo from Alzer and Diamel. All patients will undergo clinical, biochemical and ophthalmological evaluation during the study.

Daktyle

Ostatnia weryfikacja:	04/30/2018
Pierwsze przesłane:	05/10/2018
Szacowana liczba przesłanych rejestracji:	05/10/2018
Wysłany pierwszy:	05/22/2018
Ostatnia aktualizacja przesłana:	05/20/2019
Ostatnia opublikowana aktualizacja:	05/21/2019
Rzeczywista data rozpoczęcia badania:	02/28/2015
Szacowana data zakończenia podstawowej działalności:	11/30/2018
Szacowana data zakończenia badania:	12/29/2018

Stan lub choroba

Diabetic Macular Edema

Interwencja / leczenie

Dietary Supplement: Group I

Dietary Supplement: Group II

Faza

Faza 2

Grupy ramion

Ramię	Interwencja / leczenie
Experimental: Group I 32 patients with mild or moderate diabetic macular edema.	Dietary Supplement: Group I Alzer: Administration way: Oral Dosage: one 500 mg tablet 3 times a day (1500 mg daily) Frequency: after breakfast, lunch and dinner. Duration: one year. Diamel: Administration way: Oral Dosage: two 660mg capsules 3 times a day (3960 mg daily) Frequency: before breakfast, lunch and dinner. Duration: one year.
Placebo Comparator: Group II 32 patients with mild or moderate diabetic macular edema	Dietary Supplement: Group II Placebo treatment

Kryteria kwalifikacji

Wiek kwalifikujący się do nauki	18 Years Do 18 Years
Płeć kwalifikująca się do nauki	All
Przyjmuje zdrowych wolontariuszy	tak
Kryteria	Inclusion Criteria: - Diabetics type 2 insulin treated. - Age between 18 and 65 years. - Glycosylated hemoglobin (HB A1c) <8% at the beginning of the investigation. - Patients who express written voluntariness to enter the study with their signature of the informed consent document. - If woman of childbearing age, negative pregnancy test and use of barrier contraceptives. Exclusion Criteria: - Pregnancy and lactation. - Age over 65 years. - Macular edema with vitreous-retinal traction or other cause (renal, arterial hypertension, post-surgical). - Opacity of the refractive media that hinders the ophthalmological examination. - History of hypersensitivity to another similar product or one of its components. - Patients at potential risk of not compliance the study (those who will travel during the period of the investigation or distance in their residence, outside the city). - Subjects who are participating in another clinical trial Patients with cognitive disorders or a mental disorder that hinders their follow-up.

Wynik

Podstawowe miary wyników

1. Macular retinal thickness [1 year]

macular retinal measure

Miary wyników wtórnych

1. Visual acuity [1 year]

visual acuity test