BEFORE Study, Efficacy of Refigura

• Status: Completed
• Trial end date: 2018-04-16
• Target enrollment: 0
• Participant gender: All

Summary

The BEFORE study ((B) EFficacy Of REfigura) is designed to demonstrate the efficacy of REFIGURA®. It is a double-blind, randomized, monocentric study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Heilpflanzenwohl AG
• Treatments: (1-6)-alpha-glucomannan; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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:

1. Overweight-related health disorder (e.g. Hypertension, type 2 Diabetes m.)

2. Abdominal Obesity

3. A disease aggravated by obesity

4. High psychosocial pressure of suffering

Exclusion Criteria:

• 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.