An interventional study of Neofitoroid® in Hemorrhoids, sponsored by Aboca Spa Societa' Agricola. Completed at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-05-30.
Sponsored by Aboca Spa Societa' Agricola · Not applicable, Interventional, and Treatment
Evaluation of the effect and safety of NeoFitoroid® in reducing symptoms in patients with hemorrhoidal disease.
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).
221 studies on the registry are indexed under Hemorrhoids; 64 are open to participants now.
This study's enrollment of 45 is below the median of 97 across 169 interventional studies indexed under Hemorrhoids.
Browse Hemorrhoids studies →Aboca Spa Societa' Agricola is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment is made by the application of Neofitoroid® 2 times a day for 10 days.
Device: Neofitoroid®
NeoFitoroid® forms a protective barrier mucosa and on perianal region that can aid the physiological process of healing.
Also known as: Rescue therapy
To evaluate the effect of Neofitoroid® in relieving discomfort symptoms after 10 days of treatment compared to baseline (pretreatment).
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
Time frame: day 10 vs day 0
Relief in discomfort symptom at 3 and 7 days of treatment compared to baseline (pretreatment).
To evaluate the Reduction of discomfort symptom measured through a 0-100 Visual Analog Scale related to hemorrhoidal discomfort (VAS, from "no symptoms" to "overwhelming symptoms", 100-mm scale). The higher values represent a worse outcome. This secondary endpoint will be evaluated only with the hemorrhoidal discomfort VAS
Time frame: day 3 and day 7 vs day 0
Relief in pain symptom at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
To evaluate the Reduction of pain symptom measured through a 0-100 Visual Analog Scale related to hemorrhoidal pain symptom (VAS, from "no symptoms" to "overwhelming symptoms", 100-mm scale). The higher values represent a worse outcome. This secondary endpoint will be evaluated only with the hemorrhoidal pain symptom VAS
Time frame: day 3, day 7 and day 10 vs day 0
Relief in itching at 3, 7 and 10 days of treatment compared to baseline (pretreatment).
Reduction of itching symptoms measured through a 0-100 Visual Analog Scale related to hemorrhoidal itching (VAS, from "no symptoms" to "overwhelming symptoms",100-mm scale). The higher values represent a worse outcome. This secondary endpoint will be evaluated only with the hemorrhoidal itching VAS
Time frame: 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).
Reduction of burning symptoms measured through a 0-100 Visual Analog Scale related to hemorrhoidal burning (VAS, from "no symptoms" to "overwhelming symptoms", 100-mm scale). The higher values represent a worse outcome. This secondary endpoint will be evaluated only with the hemorrhoidal burning VAS
Time frame: 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).
Absolute reduction of discomfort pre and post defecation measured through a 0-100 Visual Analog Scale related to hemorrhoidal discomfort (VAS, from "no symptoms" to "overwhelming symptoms", 100-mm scale). The higher values represent a worse outcome. This secondary endpoint will be evaluated through a compiled VAS pre-defecation and a compiled VAS post-defecation. This secondary endpoint will be evaluated through mean of the differences (VAS score post-defecation - VAS score pre-defecation) at differents time of study compared to the mean measured at baseline.
Time frame: 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).
To evaluate the Reduction of bleeding as measured by a 6 point scale (never, rarely, sometimes, often, very often, always) for bleeding.
Time frame: 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).
To evaluate the Reduction of anal leakage measured by a 6 point scale (never, rarely, sometimes, often, very often, always) for bleeding
Time frame: day 3, day 7 and day 10 vs day 0
Evaluation of presence of prolapse and/or nodules after 10 days of treatment compared to baseline (if present)
To evaluate the Presence of prolapse and/or nodules after 10 days of treatment
Time frame: day 10 vs day 0
Subject quality of life (EQ-5D-5L improvement after 10 days of treatment compared to baseline (pretreatment).
To evaluate the Quality of life improvement measured with Quality of Life Index (EQ-5D-5L, MOVEMENT CAPACITY, PERSONAL CARE, LIVING ACTIVITIES, PAIN OR DISCOMFORT, ANXIETY OR DEPRESSION). The higher values represent a worse outcome.
Time frame: day 10 vs day 0
Assessment on number of defecation at day 0, 3, 7 and 10.
To evaluate the Assessment on number of defecation
Time frame: day 3, day 7 and day 10 vs day 0
Assessment on type of defecation at day 0, 3, 7 and 10.
To evaluate the Assessment on type of defecation (normal, constipated or diarrheal)
Time frame: day 3, day 7 and day 10 vs day 0
Assessment of number of relapses between end of treatment and day 31
To evaluate the Number of relapses assessed between end of treatment and day 31, through patient telephone interview.
Time frame: day 31 vs day 10
Safety and tolerability: analysis of adverse events and serious adverse events
To evaluate safety and tolerability of NeoFitoroid® through the analysis of adverse events and serious adverse events that will be recorded throughout the duration of the study.
Time frame: from day -7 to day 31
Plan to share: No
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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Aboca Spa Societa' Agricola