Prospective, multicentric, randomised, double-blind, placebo-controlle trial in a parallel-group-design to demontrate weight reduction with polyglucosamine L112 in addition to the basic programme compared to placebo in patients with overweight or obesity

Certmedica International GmbH0 个研究点目标入组 322 人开始时间: 2012年3月27日最近更新: 2024年8月19日

适应症

试验速览

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•Written consent after information;
•overweight or ICD-10 E66.00;
•Waist circumference female > 88 cm, male > 102 cm;
•age 18 to 65 years; negative pregnancy testing and a correct/effective method of contraception;
•physical activity and nutrition according to the clinical investigation plan must be possible;
•presentation of ECG and blood sample results;

•Age < 18, > 65 years respectively;
•BMI < 26, > 34.9 respectively;
•waist circumference female < 88 cm, male < 102 cm;
•pregnant or nursing (lactating) women;
•contraindication for a weight reduction:
•malignant tumour; Diabetes Typ I and II;
•actually increased fasting blood sugar;
•chronicinflammatory bowel disease;
•condition after intestinal operation;
•heart insufficiency;
•each other disease/treatment in the opinion of each investigator, which could interfear with the safety, compatibility or performance;
•alcoholic, reliance on medication or drug addiction;
•abuse of laxantia;
•known allergy to crustaceans and other ingredients of the verum or placebo tablets;
•longterm intake of medications that reduces intestinal movements;
•intake of cortikosteroids;
•not allowed comedication;
•intake of vitamin K antagonists;
•intake of medication which will cause interactions, or the are foreseeable and which can not be taken with a gap of four hours to the study medication;
•weight reduction within the last 5 monts;
•simultaneous participation in other clinical studies;
•Inability to understand the sense and purpose of this clinical study or to comply with or fulfill the conditions of the clinical investigation plan

发起方