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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
NeoFitoroid® forms a protective barrier mucosa and on perianal region that can aid the physiological process of healing.
Patologie del Tratto Alimentare, S. Orsola-Malpighi
Bologna, Italy
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
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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