RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ENE... | NCT04753775

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

NCT04753775

Sponsor

Ospedale Sandro Pertini, Roma

Status

Completed

Last Update Posted

Feb 15, 2021Actual

Enrollment

44Actual

Phase

Not Applicable

Conditions

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

Interventions

Aloe vera gel

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 10, 2010Actual

Primary Completion Date

Apr 10, 2010Actual

Completion Date

May 10, 2010Actual

First Submitted Date

Feb 9, 2021

First Submission Date that Met QC Criteria

Feb 9, 2021

First Posted Date

Feb 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2021

Last Update Posted Date

Feb 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Aloe vera gel	Drug		22 patients were assigned to Group-A 22 patients were assigned to Group-B

Measure	Description	Time Frame
endoscopic remission		4 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011350	Proctocolitis
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C586178	Aloe vera gel

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Masking Info

Masking

Single

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).

Who Masked

Participant