CTRI/2020/11/028921尚未招募4 期
A prospective randomized double blind controlled study to evaluate the efficacy and safety of Venusmin 900mg, a 100% pure and micronized Oral Diosmin in the cessation of bleeding and symptoms associated with haemorrhoids
Walter Bushnell Laboratories Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
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
- •Male or female subjects, between 18 to 65 years of age with a diagnosis of haemorrhoids (Grade I, II & III) confirmed by proctoscopic examination
排除标准
- •1. Pregnant and lactating women and women in postpartum period up to 6 weeks.
- •2. Patients with diseases like inflammatory bowel disease, cirrhosis, anal fissure, bleeding diathesis or any previous clinical history of gastroduodenal ulcer, gastrointestinal bleeding, and gastroduodenal perforation.
- •3. Subjects with a history of rectal 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 or any other procedures (including but not limited to injection sclerotherapy, rubber band ligation, photocoagulation, cryotherapy etc) within one year of enrolment into the trial.
- •6. Presence of serious co-morbidity, such as cardiovascular disease (NYHA class III or IV), cerebrovascular disease (cognitive impairment or stroke), renal or hepatic impairment (as per pt 9 below), uncontrolled hypertension (BP >140/90 at time of screening), or Diabetes (as per pt 9. below). They may be included after hypertension and diabetes are treated.
- •7. Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained.
- •8. Subjects with clinically significant abnormal laboratory values haemoglobin ( <6g/dL), PT/INR (INR >1.5), platelet count ( < 1,00,000/ml), total bilirubin ( >2 mg/dL), random blood sugar ( >140mg/dL), serum creatinine ( >2.0 mg/dL)
- •9. Treatment with any of the following at inclusion or in the previous one month like venotropic, anticoagulant or antiplatelet agent (Heparin, Warfarin, Aspirin, Clopidogrel etc.), topical anti-haemorrhoidal ointments, and steroids.
- •10.Treatment with anti-inflammatory at inclusion or in the previous one week (Ibuprofen, Diclofenac, Aceclofenac, etc)
- •11. Subjects who are current users of illicit drugs including recreational use or with a history of drug abuse within the past 5 years.
- •12. Subjects who have donated blood or plasma or participated in another clinical study with an investigational agent within the last 12 weeks.
- •13. Patients with history of hypersensitivity to diosmin and/or other excipients used in formulation of diosmin tablet.
- •14. Use of any flavonoid drug one month before inclusion (diosmin, Micronised Purified Flavonoid Fraction (diosmin and hesperidin complex, Daflon), Troxerutin/ Hydroxyethylrutosides (OXERUTE), Pilex, Hesperidin, Rutosides, Euphorbia Prostrata (SITCOM, THANK OD) etc.
研究者
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