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NCT04360889
Lipid Peroxidation and Options Antioxidant Therapy for Secondary Lymphedema of the Lower Extremities
Phase 4 trial testing Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin) in Lower Extremity Lymphedema in 120 participants. Completed in 3 August 2022.
3 August 2022
Quick facts
| Lead sponsor | Ryazan State Medical University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 120 |
| Start date | 1 September 2019 |
| Primary completion | 3 August 2022 |
| Estimated completion | 3 August 2022 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin) — full drug profile →
- Tocopherol — full drug profile →
- Elastic compression
Conditions studied
- Lower Extremity Lymphedema — all drugs for Lower Extremity Lymphedema →
Sponsor
Ryazan State Medical University
Who can join
Eligibility, any sex, with Lower Extremity Lymphedema. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A single-center, open, prospective, randomized, controlled clinical trial will include 120 patients with lower limb lymphedema who undergo treatment in an office-based vascular lab at the Ryazan regional clinical cardiology dispensary, Ryazan, Russia. The patients will be recruited by the staff of the Department of cardiovascular, endovascular, operative surgery, and topographic anatomy, Ryazan state I.P. Pavlov medical university, Russia. The study will include patients who meet the inclusion criteria and do not meet the exclusion criteria. Patients will be divided into 4 groups, 30 subjects each. Group 1-patients with lower limb lymphedema who will receive conservative therapy with elastic compression and an antioxidant (Tocopherol-400 IU/day); Group 2-patients with lower limb lymphedema who will receive conservative therapy with Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin)-1000mg/day) in addition to elastic compression; Group 3-patients with lower limb lymphedema who will be treated with elastic compression; Group 4- healthy volunteers with no history or clinical signs of venous or lymphatic disease; The duration of this study for each subject will be a maximum of 90 days. Pre-screening and screening will involve 200 subjects with a total of 120 subjects who will be randomized into the study. Peripheral blood samples will be collected to evaluate the activity of biochemical markers of endothelial function; the quality of life will also be assessed.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04360889
- Europe PMC full search
- ASCO Meeting Library
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Related trials
Other recruiting trials for Lower Extremity Lymphedema
Currently open trials in the same condition.
- NCT06750679 — The Effect of Manual Lymph Drainage Applied as an Adjunct to Compression Therapy on Edema Lower Extremity Lymphedema: · NA · recruiting
Other Ryazan State Medical University trials
Trials by the same sponsor.
- NCT05920226 — Myocardial Fibrosis in Patients With Permanent Pacemakers · active not recruiting
- NCT06367166 — Effects of Bioflavanoids on Vascular Wall Remodeling in Patients With Varicose Veins · NA · active not recruiting
- NCT05933720 — Efficacy and Safety of the Regulatory Polypeptides in Patients With Peripheral Atherosclerosis. · NA · recruiting
- NCT06806371 — PREDICTORS of CARDIOVASCULAR OUTCOMES in INDIVIDUALS with DIFFERENT OBESITY PHENOTYPES · active not recruiting
- NCT05899920 — Clinical One-stage Controlled Study of reSistant Arterial Hypertension for the desiGning of a personAlized Approach to T · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04360889 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ryazan State Medical University
- Last refreshed: 4 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04360889.
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