A Prospective open randomized, parallel group clinical study to evaluate the efficacy and safety of topical treatment in the management of Hemorrhoids in adults.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Giellepi Spa
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- 2.Improvement of pain during defecation
研究概览
简要总结
This Clinical study is being planned to assess the efficacy and safety of topical treatment in subjects with 1st and 2nd degree of Haemorrhoids with that of patients who are only on restricted diet.
In this study 45 patients with 1st and 2nd degree haemorrhoids will be included for a period of 14 days. The treatment will check for change in the following subjective symptoms like, pain, tenesmus, pruritus and anal discharge as assessed by subject at Day 7 and 14. Symptoms will be recorded by each subject daily in a diary distributed to then at visit 1.
Improvement of pain during defecation will be registered in the daily questionnaire form . Change in overall assessment of disease by the subject on a 10cm Visual Analogue scale at day 14. Change in following objective signs will be assesses by the Investigator on Day 7 and 14.
The objective of the study is to evaluate the efficacy and safety of topical treatment plus restricted diet with that of restricted diet alone in subjects with Haemorrhoids.
Type of the study - Prospective open label Randomised controlled for parallel groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
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.
- •Male or female subjects, between 18 years of age and 70 years age with a diagnosis of haemorrhoids (first or second degree).
- •Except hemorrhoids (first or second degree), the subjects are judged to be in good general health, based on medical history, physical examination.
- •If female of childbearing age, they should be willing to use an acceptable form of birth control measure.
- •They should be stable since last 3 months prior to baseline and throughout the study.
- •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.
排除标准
- •1.Pregnant and lactating women and women in post-partum period of up to 6 weeks.
- •Subjects with a history of permanent anal prolapse and/or anal fistula
- •Subjects with associated anal fissures and/or infective anal pathology.
- •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.
- •Subjects who, in the opinion of the investigator, are mentally incapacitated such that informed consent cannot be obtained.
- •Subjects with clinically significant co-morbid condition that in the opinion of the investigator could affect the efficacy and safety outcome of the study.
- •Patients under treatment with other topical therapy for haemorrhoidal syndrome.
- •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.
- •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.
- •Subjects unwilling to sign the inform consent document.
- •Any condition that in the opinion of the investigator does not justify the subjects inclusion for the study.
- •Known hypersensitivity to, or intolerance of, investigational product or any excipient.
结局指标
主要结局
2.Improvement of pain during defecation
时间窗: Screening, Day 0,7 and 14
4.Change in the following objective signs: Congestion, oedema, and exudation
时间窗: Screening, Day 0,7 and 14
5.Overall treatment satisfaction questionnaire.
时间窗: Screening, Day 0,7 and 14
1.Change in the following subjective symptoms: pain, tenesmus, pruritus and anal discharge.
时间窗: Screening, Day 0,7 and 14
3.Change in overall assessment of disease as assessed by the subject on a 10 cm Visual Analogue Scale (VAS).
时间窗: Screening, Day 0,7 and 14
次要结局
- 1.Physical Examination: Examination includes areas such as perianal skin should be assessed.(2.Any reports of adverse or serious adverse events during the treatment period.)