|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT01783119 |
|
Date of registration:
|
31/01/2013 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis
AVIUC |
|
Scientific title:
|
Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis |
|
Date of first enrolment:
|
August 2012 |
|
Target sample size:
|
60 |
|
Recruitment status: |
Recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT01783119 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
|
|
Phase:
|
Phase 0
|
|
|
Countries of recruitment
|
|
Mexico
| | | | | | | |
|
Contacts
|
|
Name:
|
Jesús K. Yamamoto-Furusho, PhD,MD |
|
Address:
|
|
|
Telephone:
|
+5554870900 |
|
Email:
|
kazuofurusho@hotmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Jesús K Yamamoto-Furusho, MD, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
INCMNSZ |
|
|
Name:
|
Lizzette C Alfaro |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
INCMNSZ |
|
|
Name:
|
Jesús K Yamamoto-Furusho, MD, PhD |
|
Address:
|
|
|
Telephone:
|
+5554870900 |
|
Email:
|
kazuofurusho@hotmail.com |
|
Affiliation:
|
|
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Patients with confirmed diagnosis by histopathology of Ulcerative Colitis with mild
activity level clinical, Endoscopic and histological.
- Extent of disease: pancolitis, ulcerative proctitis and left.
- Being treated with 5 - aminosalicylates (5-ASA).
- Belonging to the National Institute of Medical Sciences and Nutrition "Salvador
Zubirán".
- Signed informed consent.
Exclusion Criteria:
- Autoimmune diseases (lupus, HIV, cancer and any hepatitis).
- Another type of colitis (indeterminate, infectious drug and Crohn's Disease.
- Previous total colectomy.
- Body mass index less than 19.9 kg/m2 or greater than 40 kg/m2.
- Patients in remission histology, clinical and endoscopic.
- Under treatment with steroids, azathioprine, diuretics and anticoagulants.
- Use Aloe Vera or some natural therapy.
Age minimum:
18 Years
Age maximum:
59 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Ulcerative Colitis
|
|
Intervention(s)
|
|
Dietary Supplement: placebo water
|
|
Dietary Supplement: Aloe Barbadensis Miller
|
|
Primary Outcome(s)
|
|
Interleukine - 6
[Time Frame: 3 months]
|
|
Full Mayo Score
[Time Frame: 3 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|