Clinical TrialID 2122
Efficacy and Safety of Coumarin and Troxerutin in the Symptomatic Treatment of Chronic Venous Insufficiency
NCT01848210
Chronic Venous Insufficiency
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 2122
- Evidence Id
- 2122
- Core Evidence Id
- 2122
- Source Clinical Trial Id
- 2092
- Herb2 Clinical Trial Id
- HBCT002092
- Nct Id
- NCT01848210
- Title
- Efficacy and Safety of Coumarin and Troxerutin in the Symptomatic Treatment of Chronic Venous Insufficiency
- Status
- Completed
- Phase
- Phase 4
- Study Result
- Yes
- Study Condition
- Chronic Venous Insufficiency
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
- Intervention
- DRUG: Coumarin/troxerutin|DRUG: Placebo
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Quadruple
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 829
- Outcome Measure
- Mean Change (Reduction) From Baseline in Volume of Reference Leg at Week 16, Change in the partial volume of legs will be measured using a water plethysmometer. The volume of water (at 34 ± 0.2 °C) displaced after limb immersion is collected in an empty plastic Beaker which has been previously weighed (scale tare). The equilibrium/stability will be estimated using the absolute difference between measures of volume obtained at the Week 16 visit and Baseline to determine the reduction in edema., Baseline and Week 16
- Sponsor Collaborator
- Takeda
- Funded By
- INDUSTRY
- Location
- Other Id
- VN01/12|U1111-1141-7277|15030313.0.1001.5470
- Start Date
- 2013-05
- Primary Completion Date
- 2015-09
- Completion Date
- 2015-09
- First Posted
- 2013-05-07
- Results First Posted
- 2016-11-11
- Last Update Posted
- 2016-11-11
- Study Document
- Study Url
- https://clinicaltrials.gov/study/NCT01848210
- Title Cn
- Title En
- Efficacy and Safety of Coumarin and Troxerutin in the Symptomatic Treatment of Chronic Venous Insufficiency
- Bilingual Status
- semi_complete