Back to resultsRANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.
Primary Purpose
Aloe Vera Gel, Proctosigmoiditis, Remission, Trial, Ulcerative Colitis (UC)
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aloe vera gel
Sponsored by
About this trial
This is an interventional treatment trial for Aloe Vera Gel, Proctosigmoiditis, Remission, Trial, Ulcerative Colitis (UC)
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
22 patients were assigned to Group-A
22 patients were assigned to Group-B
Arm Description
22 patients were assigned to Group-A
22 patients were assigned to Group-B
Outcomes
Primary Outcome Measures
endoscopic remission
Secondary Outcome Measures
Full Information
NCT ID
NCT04753775
First Posted
February 9, 2021
Last Updated
February 9, 2021
Sponsor
Ospedale Sandro Pertini, Roma
1. Study Identification
Unique Protocol Identification Number
NCT04753775
Brief Title
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.
Official Title
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL FOR ACHIVING REMISSION IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
March 10, 2010 (Actual)
Primary Completion Date
April 10, 2010 (Actual)
Study Completion Date
May 10, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Sandro Pertini, Roma
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aloe Vera Gel, Proctosigmoiditis, Remission, Trial, Ulcerative Colitis (UC)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized controlled trial
Masking
Participant
Masking Description
22 patients were assigned to Group-A (5-ASA oral 800mg x 3 / day + 1 enema 60ml Aloe Vera gel / day) and 22 patients to Group-B (5-ASA oral 800mg x 3 / day + enema 60ml 1 Placebo / day).
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
22 patients were assigned to Group-A
Arm Type
Experimental
Arm Description
22 patients were assigned to Group-A
Arm Title
22 patients were assigned to Group-B
Arm Type
Placebo Comparator
Arm Description
22 patients were assigned to Group-B
Intervention Type
Drug
Intervention Name(s)
Aloe vera gel
Primary Outcome Measure Information:
Title
endoscopic remission
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENEMA ALOE VERA GEL IN ACTIVE ULCERATIVE PROCTOSIGMOIDITIS.
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