Study to evaluate the efficacy and safety of sitcom forte tablet euphorbia prostrata 100 mg and calcium dobesilate 500 mg and sitcom cream euphorbia prostrata dry extract Cream in treatment of varicose veins
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- 1.Change in VVSymQ scores for symptoms (Pain in Legs, Swelling, Tingling, Numbness in legs and itching around veins).
研究概览
简要总结
Subjects having varicose veins and found to be eligible asper inclusion-exclusion criteria would be enrolled in the study after informedconsent signed. Total 100 patients will be enrolled in this study.Each subject will be followed up for 3months. The protocol specifiedvisits would be as Visit 1- Baseline, Visit 2 - End of 1 month, Visit 3 - Endof 2 month, Visit 4 - End of 3 month. Each visit subsequent to enrollment, willallow for 2 additional days to attend the protocol specified clinic visit. If subject discontinues from the studymedication on or before visit 2 (either drop out or due to any adverse drugreaction) then visit 2 will be considered as the study completion visit and noactivities listed for the visit 3 will be performed. Subject will beinstructed to report at study site for any SAE observed within 30 days of studycompletion.Investigator/designee will enter the subject’s datain the respective Case Report Form (CRF). In case any observation at anyspecified time point in not done or data is unavailable then the same should bedocumented as not done (ND) in the CRF.The study would be conducted in accordance with theprotocol for the study approved by the concerned Ethics Committee, and anyamendments to the said protocol that the Ethics Committee may approve from timeto time. The investigator will take all trial related medical decisions at thesite. This includes the medical care provided for inter-current illnesses orany adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient is diagnosed with primary or symptomatic varicose veins and not indicated for any surgical intervention.
- •2.Patients is willing to participate in the current study and sign the informed consent form.
- •3.Patients is not on any other allopathic / herbal medication (oral or topical) for the treatment of varicose veins for last 7 days.
排除标准
- •1.Lactating women.
- •Women in post –partum period of up to 6 weeks.
- •2.Patient having hypersensitive predisposition or hypersensitive to any of components of the study drug.
- •3.Clinically significant co-morbid condition that in the opinion of the investigator could affect patient.
结局指标
主要结局
1.Change in VVSymQ scores for symptoms (Pain in Legs, Swelling, Tingling, Numbness in legs and itching around veins).
时间窗: 2 months
2.Change in skin color.
时间窗: 2 months
3.Change in number and size of venous ulcers
时间窗: 2 months
4.Decrease in rate of Occlusion
时间窗: 2 months
5.Venous ulcer reduction
时间窗: 2 months
6.Venous Stasis changes
时间窗: 2 months
7.Overall Improvement in Disease (By Investigator and Patient)
时间窗: 2 months
8.Treatment Assessment (By Investigator and Patient)
时间窗: 2 months
次要结局
- 1.Number of Adverse Events during the study duration(3 months)