CTRI/2009/091/001020已完成2 期
A double-blind, double dummy, randomized, placebo-controlled, multicentre, dose response study to evaluate the safety and efficacy of three doses of Euphorbia prostrata Dry Extract tablets in patients of first and second degree internal hemorrhoids
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Adult subjects who are able to understand nature, significance and scope of the clinical trial and express their will accordingly and agreeing to participate in the study by giving written informed consent.
- •2.Male or female subjects, at least 18 years of age with a diagnosis of internal hemorrhoids (first and second degree) confirmed by proctoscopic examination and suffering from an uncomplicated and untreated acute attack (defined as acute onset of per rectal bleeding within 3 days of inclusion into the study, with at least one of the symptoms viz. pain, tenesmus, pruritus and anal discharge).
- •3.Except internal hemorrhoids (first and second degree), the subjects are judged to be in good general health, based on medical history, physical examination, and laboratory screening tests.
排除标准
- •1.Pregnant and lactating women and women in post-partum period of up to 6 weeks.
- •2.Women of child bearing potential who do not agree to remain abstinent or use medically acceptable methods of contraception during the study therapy and for 4 weeks after the end of study therapy.
- •3.Subjects with a history of permanent anal prolapse and/or anal fistula
- •4.Subjects with associated anal fissures and/or infective anal pathology.
- •5.Subjects with previous history of surgery for anorectal disease (within 5 years) or any other procedures (including but not limited to injection sclerotherpy, rubber band ligation, photocoagulation, cryotherapy etc) within 2 year of enrolment into the trial.
- •6.Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained.
- •7.Subjects with clinically significant co-morbid condition that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
- •8.Subjects with clinically significant laboratory values for bleeding time, clotting time, PT/INR, aPTT/control, platelet count, SGOT, SGPT, alkaline phosphatase, total bilirubin,.
- •9.Treatment with any of the following at inclusion or in the previous one month venotropic, anticoagulant, and anti platelet agent. Subjects on aspirin up to 160 mg for cardiovascular indication will not be excluded from the trial.
- •10.Treatment with any of the following at inclusion or in the previous one week anti-inflammatory and analgesic agent.
- •11.Other chronic medications not being used at a stable dosage for at least 2 weeks.
研究者
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