RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.

February 9, 2021 updated by: Roberta Pica, Ospedale Sandro Pertini, Roma

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL FOR ACHIVING REMISSION IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.

Aloe vera is used for the treatment of inflammatory bowel disease (IBD), but no data are present in regard the gel formulation as topical therapy in active ulcerative colitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

44 ulcerative colitis (UC) patients were enrolled and randomly allocated to treatment for 4 weeks with oral mesalazine (800 mg three times daily) and enema (60 ml aloe vera gel) 1/day (n = 22, Group A) or enema (60 ml placebo) (n = 22, Group B).

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age over 18 years, mild to moderate active ulcerative proctosigmoiditis, diagnosed for the first time and no therapy started before. The maximum extension of the disease was accepted of 40-60 cm from the anal verge or distal disease.

Exclusion Criteria:

  • an extension of disease above the sigma, renal impairment, pregnancy, lactation or established low compliance

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 22 patients were assigned to Group-A
Drug: Aloe vera gel
Placebo Comparator: 22 patients were assigned to Group-B
Drug: Aloe vera gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
endoscopic remission
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale Sandro Pertini, Roma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2010

Primary Completion (Actual)

April 10, 2010

Study Completion (Actual)

May 10, 2010

Study Registration Dates

First Submitted

February 9, 2021

First Submitted That Met QC Criteria

February 9, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

February 15, 2021

Last Update Submitted That Met QC Criteria

February 9, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rif. 1836/11.03.10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aloe Vera Gel, Proctosigmoiditis, Remission, Trial, Ulcerative Colitis (UC)

  • Massachusetts General Hospital
    Recruiting
    Family Members At INcreased-risk for Developing Inflammatory Bowel Disease (FIND-IBD)
    Crohn's Ileocolitis | Crohn's Gastritis | Crohn's Jejunitis | Crohn's Duodenitis | Crohn's Esophagitis | Inflammatory Bowel Disease (IBD) | Crohn's Colitis | Indeterminate Colitis | Ulcerative Colitis (UC) | Ulcerative Proctitis | Ulcerative Proctosigmoiditis | Crohn's Disease Colon | IBD-unclassified (IBD-U)
    United States

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