BEFORE-Study for the Evaluation of Safety and Efficacy of Polyglucosamin and Glucomannan Combination.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Changes in Bodyweight
研究概览
简要总结
The BEFORE study ((B) EFficacy Of REfigura) is designed to demonstrate the efficacy of REFIGURA®. It is a double-blind, randomized, monocentric study.
详细描述
Core data from the BEFORE study:
Sponsor: Heilpflanzenwohl AG Product: REFIGURA® Title: BEFORE study: Demonstrating the efficacy of REFIGURA® through a double-blind, three-arm, randomized, monocentric study Study duration: 8 weeks (56 days) Study location: MIT Gesundheit GmbH, Stechbahn 20-22, 47533 Kleve CRO: MIT Health GmbH, Stechbahn 20-22, 47533 Kleve Number of study participants: 165 (55 patients per treatment arm)
Summary:
REFIGURA® (manufactured by KITOZYME, Parc Industriel des Hauts-Sarts, Zone 2, Rue de Milmort, 680, BE-4040 Herstal, Belgium, Distribution: Heilpflanzenwohlkraft GmbH), is an approved medical device containing a combination of chitosan (a polyglucosamine ) and glucomannan. Chitosan is a vegetable fiber that binds fats in the intestinal lumen. Both substances are already approved and show few side effects. They are not absorbed into the body, but work directly in the intestine.
The investigational medicinal products are used to treat obesity (weight loss) and to control weight. The effect is based on a reduction in caloric intake, by increasing the feeling of satiety and at the same time the appetite is reduced. As a result, the amount of food consumed is reduced and excessive food (cravings attacks) is prevented. It also reduces the intake of dietary fats.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
double-blind, randomized
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 20-50 years
- •Body mass index (BMI) ≥ 30 kg/m² or
- •BMI between 25 and ˂ 30 kg/m² and simultaneous existence of at least one of the following factors:
- •Overweight-related health disorder (e.g. Hypertension, type 2 Diabetes m.)
- •Abdominal Obesity
- •A disease aggravated by obesity
- •High psychosocial pressure of suffering
排除标准
- •Pregnancy (examination with the help of a pregnancy test using urine Lab Test at V2) and lactation
- •Alcohol, drugs and drug abuse
- •Limited compliance (pre-questionnaire examination)
- •History of malignant tumors
- •(chronic) Inflammatory diseases of the gastrointestinal tract
- •Gastroparesis (stomach paralysis) in the anamnesis
- •Signs of an intestinal closure (arising or existing mechanical or paralytic Ileus) in the anamnesis
- •Gastric bridging surgery or gastric reduction
- •Hypersensitivity or allergy to the ingredients
- •Untreated or inadequately treated hypertension
- •Diabetes mellitus (examination with the help of a urine tests)
- •Treatment with diuretics or insulin
- •Cortisone, which has a systemic effect
- •Smokers who want to start weaning during the trial
- •Untreated or insufficiently treated thyriodale disorders (if the patient is stable in the opinion of the physician, he may participate in the study)
- •Cardiac edema
- •Participation in weight reduction programs in the past 30 days
- •Patients with swallowing problems, intestinal polyps or severe digestive disorders
- •Patients with a history of constipation
- •Patients who take drugs containing fat-soluble active substances and in which the time-consuming conditions of these drugs (see instructions for taking in Appendix O) are incompatible with the intake instructions of this study.
研究组 & 干预措施
Polyglucosamine Glucomannan normal dose
Patients received the single dose Polyglucosamine und Glucomannan (0,5 g resp. 1 g per Stick) three times per day over 65 days. The drug is administered as a powder which is dissolved in water. The solution is taken orally.
干预措施: Polyglucosamine Glucomannan normal dose (Verum) (Drug)
Polyglucosamine Glucomannan high dose
Patients received the higher dose of Polyglucosamine und Glucomannan (1 g resp. 1,34 g per Stick) three times per day over 65 days. The drug is administered as a powder which is dissolved in water. The solution is taken orally.
干预措施: Polyglucosamine Glucomannan high dose (Verum) (Drug)
结局指标
主要结局
Changes in Bodyweight
时间窗: Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks)
Changes in bodyweight during the study (weight reduction in kg). Comparison of the values obtained on day1 with results from day 65.
次要结局
- Changes in blood pressure(Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks))
- Changes in BMI(Every two weeks (Start, 2 weeks, 4 weeks, 6 weeks, 8 Weeks))
- Safety: occurence of adverse events(Every week (from week 1 to week 10))