Study to evaluate the efficacy and safety of sitcom tablet (euphorbia prostrata dry Extract 100 mg) and sitcom cream (euphorbia prostrata dry Extract cream) in treatment of haemorrhoids during pregnancy.
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.Cessation of per rectal bleeding
研究概览
简要总结
Pregnant females having hemorroids, analregion pain and found to be eligible as per inclusion-exclusion criteriawould be enrolled in the study after signing informed consent.Approximately 100 subjects will be enrolled in this study.Each patient will be followed up for 2 months after treatment and 1month post-delivery. The protocolspecified visits would be as Visit 1- Baseline, Visit 2 - End of 1 week, Visit 3- End of 2 week, Visit 4 - End of 4 week, Visit 5 - End of 2 months Visit 6 -End of 1 month Post-Delivery. Each visit subsequent to enrollment,will allowfor 2 additional days to attend the protocol specified clinic visit. If patient 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 no activities listed for thevisit 3 will be performed. Patient will be instructed to report at studysite for any SAE observed within 30 days of study completion.Investigator/designee will enter the patient’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 thestudy site. This includes the medical care provided for inter-current illnessesor any 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
- Female
入选标准
- •1.Pregnant Female patient, at least 18 years of age with a complaint of hemorrhoids during pregnancy.
- •2.Patient is willing to participate in the current study and sign the informed consent form.
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.Cessation of per rectal bleeding
时间窗: 4 week
3.Relief from Itching, exudation and swelling
时间窗: 4 week
4.Re-treatment initiation required during study duration
时间窗: 4 week
5.Overall improvement in disease condition (assessed by Patients and Physicians) V3 End of 2 week
时间窗: 4 week
2.Relief from pain at defecation
时间窗: 4 week
7.Overall improvement in disease condition assessed by Physician
时间窗: 4 week
6.For Hemorrhoids Overall improvement in disease condition assessed by Patients
时间窗: 4 week
次要结局
- 1.Number of Adverse Events during the study duration.(2 months)