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Topical Vitamin E Ovules for the Treatment of Hemorrhoids

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04362384
Recruitment Status : Not yet recruiting
First Posted : April 24, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

Brief Summary:

Patients with hemorrohoids grade II and III were included. Patients were randomized into 2 groups:

  • Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus
  • Control group: Patients will receive a treatment with corticoid ointment, with endoanal application

Bleeding, pain and stinging will be evaluated 14 days after beginning the treatment.


Condition or disease Intervention/treatment Phase
Bleeding Anal Pain Stings Drug: Vitamin E ovules Drug: Prednisolone ointment Phase 3

Detailed Description:

Patients with hemorrohoids grade II and III were included.

Patients were randomized into 2 groups:

  • Experimental group: Patients will receive a treatment with vitamin E ovules, which must be placed inside the annus. 1 ovule must be inserted daily during 14 days.
  • Control group: Patients will receive a treatment with prednisolone ointment, with endoanal application 3 times per day during 14 days.

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Symptoms will be assessed by a nurse blinded to the prescribed treatment
Primary Purpose: Treatment
Official Title: Topical Endorectal Vietamin E Ovules for the Treatment of Grade 2 and 3 Hemorrhoids
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : October 30, 2020


Arm Intervention/treatment
Experimental: Vitamin E ovules
Endoanal Vitamin E ovules will be prescriped during 14 days
Drug: Vitamin E ovules
Endoanal vitamin E ovules will be prescribed

Active Comparator: Prednisolone ointment
Endoanal Prednisolone ointment will be prescriped during 14 days
Drug: Prednisolone ointment
Endoanal Prednisolone ointment will be prescribed




Primary Outcome Measures :
  1. % of patients with Bleeding [ Time Frame: 14 days after beginning the treatment ]
    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)


Secondary Outcome Measures :
  1. Anal pain assessed by Visual Analogic Scale [ Time Frame: 14 days after beginning the treatment ]
    The patients will be asked to quantify their perception of pain on a VAS, ranging from 0mm(absence of pain) to 100mm (unbearable pain)

  2. % of patients with Stinging [ Time Frame: 14 days after beginning the treatment ]
    The patient refers stinging sensation (patients´self-report) . The variable will be measured as present (1) or absent(0)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Grade II and III hemorrhoids

Exclusion Criteria:

  • Grade I or IV hemorrhoids
  • Patients with previous anal surgeries
  • Patients having received previous pharmacological treatments for hemorrhoids

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04362384


Contacts
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Contact: Jaime Ruiz-Tovar 630534808 jruiztovar@gmail.com
Contact: Carolina LLavero Garrido 649593020 carolinallavero@gmail.com

Sponsors and Collaborators
Hospital General Universitario Elche
Investigators
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Principal Investigator: Jaime Ruiz Tovar Polo Garcilaso Clinic
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Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Department of Surgery, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT04362384    
Other Study ID Numbers: Garcilaso 2020/2
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Vitamin E
Prednisolone
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action