A Phase 3 interventional study of Vitamin E ovules and Prednisolone ointment in Bleeding Anal, Pain and Stings, sponsored by Hospital General Universitario Elche. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by Hospital General Universitario Elche · Phase 3, Interventional, and Treatment
Patients with hemorrohoids grade II and III were included. Patients were randomized into 2 groups:
Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment.
Patients with hemorrohoids grade II and III were included.
Patients were randomized into 2 groups:
Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment. Quantification of pain will be performed following a visual analogic scale ranging from 0 (absence of symptoms) to 100 (unbearable symptoms).
338 studies on the registry are indexed under Gastrointestinal Hemorrhage; 77 are open to participants now.
This study's planned enrollment of 120 is above the median of 98 across 210 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →Hospital General Universitario Elche is the lead sponsor of 44 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Endoanal Vitamin E ovules will be prescriped during 14 days
Drug: Vitamin E ovules
Endoanal Prednisolone ointment will be prescriped during 14 days
Drug: Prednisolone ointment
Endoanal vitamin E ovules will be prescribed
Endoanal Prednisolone ointment will be prescribed
% of patients with Bleeding
The patient refers rectal bleeding during defecation (patients´self-report) or active bleeding is observed at rectal examination. The variable will be measured as present (1) or absent(0)
Time frame: 14 days after beginning the treatment
Anal pain assessed by Visual Analogic Scale
The patients will be asked to quantify their perception of pain on a VAS, ranging from 0mm(absence of pain) to 100mm (unbearable pain)
Time frame: 14 days after beginning the treatment
% of patients with Stinging
The patient refers stinging sensation (patients´self-report) . The variable will be measured as present (1) or absent(0)
Time frame: 14 days after beginning the treatment
No study locations are listed for this record.
Start is estimated for May 2020; primary completion for Oct 2020, 5 months later.
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This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Hospital General Universitario Elche