Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-25 @ 2:34 AM
NCT ID:
NCT02184234
Eligibility Criteria:
Inclusion Criteria:
* Chronic venous insufficiency stage I or II according to Widmer, e.g., resulting in lower-leg oedema
* Male or female out-patients of any ethnic origin
* Age ranging from 25 to 75 years
Exclusion Criteria:
* Known hypersensitivity to any ingredients of the study medication
* Oedema(s) of non-venous origin, e.g., due to cardiac insufficiency, lymphoedema or decompensated cardiac insufficiency, orthopaedic disturbances
* Florid venous ulcers
* Arterial occlusive disease, irrespective of the severity
* Phlebitis or thrombophlebitis
* Clinical indication for an acute phlebologic intervention, e.g., compressive treatment, phlebectomy, etc.
* Evidence of diabetic micro-angiopathy or polyneuropathy in medical history
* Poor general health (based on the investigator's judgement)
* Addiction to alcohol abuse
* Mental illness and inability (or limited ability) to work, or inability (or limited ability) to follow spoken or written explanations concerning the trial
* Women of child-bearing age not using any reliable contraceptive methods
* Pregnant or lactating women
* Patients previously enrolled in the present study or participating in another clinical study, or who had taken part in another study within the previous 90 days
* Patients receiving compression therapy, high-ceiling diuretics (e.g., furosemide), or any other anti-CVI preparations (e.g., vasoprotectives to treat varicosis, such as heparin-containing preparations, sclerosing agents, or bioflavonoids other than the study medication) during the trial. Medications or measures for CVI had to be stopped 14 day prior to intake of study medication.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
25 Years
Maximum Age:
75 Years
Study:
NCT02184234
Study Brief:
Protocol Section:
NCT02184234