A randomized double blind placebo controlled Safety and efficacy study of Lenoid, a topical treatment for symptoms relief in patients with haemorrhoids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Giellepi Spa
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time taken for 35% reduction (compared to baseline) of the overall score (total sum of each individual score of Questionnaires: Appendix G, Appendix H and Appendix I) of active product when compared to placebo.
研究概览
简要总结
Randomized, double blind, placebo controlled studies are considered to be of the highest standards for the assessment of efficacy and safety of a study medication; accordingly the same design is used for this study. Patients with hemorrhoids (1st and 2nd degree) will be enrolled in the study to assess the safety and efficacy of LENOID (tube consisting of the cream for topical administration)
Patients with severe state of disease (4th Degree) will not be enrolled in the study as this is a placebo controlled trial and half of the patients in the study will not be receiving any active treatment. 60 patients (male and female aged above 18 years) will be enrolled into the study. There will be 2 Groups in the study. First group consists of 30 patients receiving LENOID and the Second group is of 30 patients receiving matching Placebo. Both the groups will be on a controlled diet for the entire study duration of 14 days.
Type of study: A prospective, randomized, double blind, parallel, placebo controlled, single-centre, clinical study.
Study groups Test group: LENOID (tube consisting of the cream for topical administration) of GIELLEPI S.p.A. (Italy) Reference group: Matching Placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects willing to give written informed consent.
- •2.Male or female subjects, more than 18 years of age with a diagnosis of haemorrhoids (first or second degree).
- •â€¨ 3.Except haemorrhoids (first or second degree), the subjects are judged to be in good general health, based on medical history, physical examination.
- •They should be stable since last 3 months prior to baseline 
and throughout the study.
- •â€¨ 5.Subjects accepting to be on controlled and balanced diet (with exclusion of 
some foods including hot chili, pepper, chocolate, alcoholic drinks, fried foods).
- •Tea and coffee will be restricted to not more of 2 cups per day.
- •6.Subjects who were on phlebotonic drugs but who are not on the medications since 2 months before the recruitment can be included in the study.
排除标准
- •1.Pregnant and lactating women and women in post-partum period of up to 6 weeks.
- •â€¨ 2.Subjects with a history of permanent anal prolapse and/or anal fissures and/or infective anal pathology.
- •â€¨ 3.Subjects with previous history of surgery for anorectal disease (within 5 years) or any other procedures (including but not limited to injection sclerotherapy, rubber band ligation, photocoagulation, cryotherapy etc) within 2 years of enrolment into the trial.
- •â€¨ 4.Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained.
- •â€¨ 5.Subjects with clinically significant co-morbid condition that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
- •â€¨ 6.Patients under treatment with other topical therapy for haemorrhoidal syndrome.
- •7.Patients under treatment with plebotonic drugs or phlebotonic dietary supplements (i.e. diosmin etc.).
- •8.Subjects participating in any other clinical trial currently or if he/she has completed the trial participation less than 3 months from screening for the current study.
- •9.Presence of disease states that could affect safety and efficacy 
evaluation, such as hepatic (e.g., cirrhosis with Child-Pugh Class B or C or MELD score > 9), renal (e.g., requiring dialysis), gastrointestinal (e.g., acute or chronic diverticulitis, irritable bowel syndrome with epigastric pain as a predominant symptom or active inflammatory bowel disease), hematologic, neurologic or brain disorders (e.g., strokes, and brain injury), psychiatric (e.g., bipolar disorder, severe active depression, severe active anxiety), or any other significant condition which, in the opinion of the Investigator, could confound or interfere with evaluation of efficacy, safety, or tolerability of the investigational drug, or prevent compliance with the study protocol.
 10.Subjects unwilling to sign the inform consent document.
- •11.Any condition that in the opinion of the investigator does not justify the subjects
inclusion for the study.
- •12.Known hypersensitivity to, or intolerance of, investigational product or any excipient.
- •13.During the course of the study no other medications should be consumed.
- •Only rescue medications to be used with the recommendatuons from the Pricipal Investigtor and this should be recorded in the CRF.
结局指标
主要结局
Time taken for 35% reduction (compared to baseline) of the overall score (total sum of each individual score of Questionnaires: Appendix G, Appendix H and Appendix I) of active product when compared to placebo.
时间窗: Screening Day 0 7 14
次要结局
- 1.Reduction of the score of each symptom at day 7 and 14 .(2.Reduction of the overall score (total sum of each individual score of the following symptoms: pain, tenesmus, pruritus and anal discharge .)