NCT04753775

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2010

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 10, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2010

Completed
10.8 years until next milestone

First Submitted

Initial submission to the registry

February 9, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
Last Updated

February 15, 2021

Status Verified

February 1, 2021

Enrollment Period

1 month

First QC Date

February 9, 2021

Last Update Submit

February 9, 2021

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • endoscopic remission

    4 weeks

Study Arms (2)

22 patients were assigned to Group-A

EXPERIMENTAL

22 patients were assigned to Group-A

Drug: Aloe vera gel

22 patients were assigned to Group-B

PLACEBO COMPARATOR

22 patients were assigned to Group-B

Drug: Aloe vera gel

Interventions

Aloe vera gelDRUG
22 patients were assigned to Group-A22 patients were assigned to Group-B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

ProctocolitisColitis, Ulcerative

Interventions

Aloe vera gel

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesProctitisColonic DiseasesIntestinal DiseasesSigmoid DiseasesRectal DiseasesInflammatory Bowel Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 15, 2021

Study Start

March 10, 2010

Primary Completion

April 10, 2010

Study Completion

May 10, 2010

Last Updated

February 15, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share