Efficacy and safety of euphorbia prostrata in the management of chronic venous disease: a randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Reduction in pain scores (VAS scale)
研究概览
简要总结
This research aims to evaluate the efficacy and safety of Euphorbia prostarta extract compared to Pilex and surgical intreventions in 300 patients with Chronic venous disease (CVD), including varicose veins and hemorrhoids. Conducted over 24 months at SRM Medical College Hospital, The study will randomize participants into three equal groups (n=100 each) using block randommization. Primary outcomes include improvement in venous reflux (Duplex Ultasonography) and hemorrhoid severity metabolic markers, quality of life (civiq-20), and safety (CBC, LFT, RFT). Assesments will occur at baseline, weeks 12 and 24, with interim telephonic followups. the study adressses a gap in robust evidence for herbal therapies in chronic venous disease and complies with ICH-GCP and ICMR ethical guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18 to 65 years with clinically diagnosed primary varicose veins CEAP C2 to C
- •Symptomatic patients presenting with pain, swelling, pigmentation, or skin changes.
- •Eligible for treatment with Euphorbia prostrata, Pilex or surgery.
- •Willing to provide informed consent and comply with follow up visits for 24 weeks.
排除标准
- •Diagnosis of secondary varicose veins, including cases related to deep vein thrombosis, trauma or congenital venous anomalies.
- •Presence of active venous ulcers CEAP class C5 to C6 or infective dermatitis at the study entry.
- •Known systemic conditions such as hepatic impairment, renal dysfunction, coagulopathies, or uncontrolled diabetes.
- •Pregnancy, lactation or known allergy to study medications.
结局指标
主要结局
Reduction in pain scores (VAS scale)
时间窗: Baseline visit (Day 1) | Day 90 (plus or minus 3 days) | Final visit at Day 180 (plus or minus 3 days) - End of study
Decrease in bleeding episodes (hemorrhoids)
时间窗: Baseline visit (Day 1) | Day 90 (plus or minus 3 days) | Final visit at Day 180 (plus or minus 3 days) - End of study
Improvement in heaviness/aching (varicose veins)
时间窗: Baseline visit (Day 1) | Day 90 (plus or minus 3 days) | Final visit at Day 180 (plus or minus 3 days) - End of study
Objective Clinical Measures
时间窗: Baseline visit (Day 1) | Day 90 (plus or minus 3 days) | Final visit at Day 180 (plus or minus 3 days) - End of study
Reduction in hemorrhoid size (proctoscopy grading)
时间窗: Baseline visit (Day 1) | Day 90 (plus or minus 3 days) | Final visit at Day 180 (plus or minus 3 days) - End of study
Improvement in venous refill time (Doppler ultrasound)
时间窗: Baseline visit (Day 1) | Day 90 (plus or minus 3 days) | Final visit at Day 180 (plus or minus 3 days) - End of study
Decrease in visible varicosity severity (CEAP classification)
时间窗: Baseline visit (Day 1) | Day 90 (plus or minus 3 days) | Final visit at Day 180 (plus or minus 3 days) - End of study
次要结局
- Metabolic & Systemic Parameters
研究者
Dr AP Rohith
Srm Institute of Science and Technology