NCT03545724已完成不适用
Prospective, Single Arm, Open Study to Evaluate the Effect of NeoFitoroid® in Reducing Symptoms in Patients With Hemorrhoidal Disease
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- To evaluate the effect of Neofitoroid® in relieving discomfort symptoms after 10 days of treatment compared to baseline (pretreatment).
研究概览
简要总结
Evaluation of the effect and safety of NeoFitoroid® in reducing symptoms in patients with hemorrhoidal disease.
详细描述
Evaluation of the effect and safety of NeoFitoroid® in relieving discomfort symptom after 10 days of treatment compared to baseline (pretreatment).
The study duration per patient is 31 days (visit 1 + 10 days treatment + 20 days follow-up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes ≥ 18 years .
- •Diagnosis of hemorrhoidal disease of grade I or II, non thrombosed, according to Goligher's classification performed by anoscopy/rectoscopy at screening.
- •Patient is not expected to require non-pharmacological (as Sclerotherapy, Rubber band ligation, Infrared Coagulation, Radiofrequency Ablation, Cryotherapy) or surgical treatment in the 31 days post enrollment .
- •Discomfort score related to the hemorrhoidal disease ≥ 30 measured through a 0-100 Visual Analog Scale VAS (from "no symptoms" to "overwhelming symptoms") at screening.
- •Women of childbearing potential undergone a negative pregnancy test.
- •Informed consent documentation signed and dated confirming that the patient has been adequately informed of all aspects related to his/her participation in the clinical study and is willing to participate.
排除标准
- •Patients with gastrointestinal disease like inflammatory bowel disease, celiac disease, colo-rectal cancer, perianal/fistulizing disease).
- •Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may interfere with the interpretation of study results and/or that, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- •Patients with active cancer.
- •Tubercolosis , mycosis, Herpes Symplex, virologic disease with anal or perianal skin localization.
- •Presence of physical and/or mental disability that reduces the ability to take medicines as expected.
- •Concomitant abuse of drugs or alcohol.
- •No adequate reliability or presence of conditions that may result in non-compliance / adherence of the patient to the Protocol.
- •Subjects with known or suspected allergy to plants of Helichrysum family, aloe vera, Ruscus, Hypericum, Jojoba Oil, Shea Butter, Essential oils of: Melaleuca, Cypress and Peppermint.
- •Subjects with known or suspected allergy to ingredients such as: glicerilstearato, Caprylic / capric, sucrose distearate, sucrose stearate, cetearyl alcohol, vegetable glycerin, triidrossistearina, vegetable oils, hydrogenated vegetable oils, Candelilla wax, xanthan gum, citric acid, tocopherols, sodium silicate, benzyl alcohol, potassium sorbate, sodium dehydroacetate, Sunflower oil.
- •Subjects with the presence of alarm symptoms (weight loss, lack of appetite).
- •Prior use of other topical ointment for the treatment of haemorrhoid within 14 days before enrollment.
- •Pregnant and/or breastfeeding patients.
- •Participation in interventional research studies of investigational medicinal or device products (ongoing or terminated less than 30 days before screening).
研究组 & 干预措施
Neofitoroid®
Experimental
Treatment is made by the application of Neofitoroid® 2 times a day for 10 days.
干预措施: Neofitoroid® (Device)
结局指标
主要结局
To evaluate the effect of Neofitoroid® in relieving discomfort symptoms after 10 days of treatment compared to baseline (pretreatment).
时间窗: day 10 vs day 0
Reduction of discomfort symptoms measured through a 0-100 Visual Analog Scale related to hemorrhoidal discomfort (VAS, from "no symptoms" to "overwhelming symptoms", 100-mm scale) after 10 days of treatment compared to baseline. The higher values represent a worse outcome. Primary endpoint will be evaluated only with the hemorrhoidal discomfort VAS
次要结局
- Evaluation of presence of prolapse and/or nodules after 10 days of treatment compared to baseline (if present)(day 10 vs day 0)
- Relief in itching at 3, 7 and 10 days of treatment compared to baseline (pretreatment).(day 3, day 7 and day 10 vs day 0)
- Absolute reduction of discomfort pre and post defecation at 3, 7, and 10 days of treatment compared to baseline (pretreatment).(day 3, day 7 and day 10 vs day 0)
- Reduction of bleeding at 3, 7 and 10 days of treatment compared to baseline (pretreatment).(day 3, day 7 and day 10 vs day 0)
- Reduction of anal leakage at 3, 7 and 10 days of treatment compared to baseline (pretreatment).(day 3, day 7 and day 10 vs day 0)
- Relief in discomfort symptom at 3 and 7 days of treatment compared to baseline (pretreatment).(day 3 and day 7 vs day 0)
- Subject quality of life (EQ-5D-5L improvement after 10 days of treatment compared to baseline (pretreatment).(day 10 vs day 0)
- Relief in pain symptom at 3, 7 and 10 days of treatment compared to baseline (pretreatment).(day 3, day 7 and day 10 vs day 0)
- Relief in burning at 3, 7 and 10 days of treatment compared to baseline (pretreatment).(day 3, day 7 and day 10 vs day 0)
研究者
研究点 (2)
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