Ulcerative ColitisEarly Phase 1AVIUCNCT01783119
Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis
A Early Phase 1 study testing Aloe Barbadensis Miller in people with Ulcerative Colitis, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
Trial summary
The Ulcerative Colitis (UC) belongs to the group of diseases called Inflammatory Bowel Disease (IBD) which is characterized by a chronic ulceration of the colon. The conventional treatment can have adverse effects and does not guarantee effectiveness in some patients requiring aggressive therapy using adjuvant therapy… Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Aloe Barbadensis Miller
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- Aug 2012to Dec 2014
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
National Institute of Medical Science and Nutrition, Salvador Zubirán
D.f., Tlalpan, 14000
Jesús K Yamamoto-Furusho, MD, PhD, +5554870900 ext. 2710, kazuofurusho@hotmail.com
About this study
The Ulcerative Colitis (UC) belongs to the group of diseases called Inflammatory Bowel Disease (IBD) which is characterized by a chronic ulceration of the colon. The conventional treatment can have adverse effects and does not guarantee effectiveness in some patients requiring aggressive therapy using adjuvant therapy Aloe vera has been shown to have a beneficial effect in different disease, and have an anti-inflammatory effect in UC patients. Objective: Measuring the effect of the consumption of 200 ml of aloe vera gel daily for a period of three months, in the degree of inflammation in patients with mild UC based on Mayo scale and quantification of IL-6 in the colonic mucosa.
- Conditions
- Ulcerative Colitis
- Being tested
- Aloe Barbadensis Miller, placebo water
- Keywords
- Ulcerative Colitis, Aloe Vera
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aloe Barbadensis MillerDietary supplement
placebo waterDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Aloe Vera | Experimental | Consume 200 ml of aloe vera gel per day over a period of three months Receives: Dietary Supplement: Aloe Barbadensis Miller |
| water | Placebo comparator | Consume 200 ml of placebo per day over a period of three months Receives: Dietary Supplement: placebo water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full Mayo Score
Measured: 3 months
Interleukine - 6
Quantification in mucosal Biopsy
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startAug 2012
- Primary completionDec 2013 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesús Kazuo Yamamoto Furusho, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
- Investigators
- Jesús K Yamamoto-Furusho, MD, PhD, Study chair, INCMNSZLizzette C Alfaro, Principal investigator, INCMNSZ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783119
- Sponsor's protocol ID
- REF.589
- Acronym
- AVIUC
- Status last verified
- Jan 2013
- First submitted
- 31 Jan 2013
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14.
PubMed 22001864Bosques-Padilla FJ, Sandoval-Garcia ER, Martinez-Vazquez MA, Garza-Gonzalez E, Maldonado-Garza HJ. [Epidemiology and clinical characteristics of ulcerative colitis in north-eastern Mexico]. Rev Gastroenterol Mex. 2011 Jan-Mar;76(1):34-8. Spanish.
PubMed 21592901[Clinical guidelines for the diagnosis and treatment of chronic ulcerative colitis (CUC). Diagnosis. Usefulness of clinical data and laboratory analysis]. Rev Gastroenterol Mex. 2007 Jul-Sep;72(3):298-9. No abstract available. Spanish.
PubMed 18402220López-Rosés L, Olivencia-Palomar P. Colonoscopia. Rev. esp. enferm. dig. 100(6): 372-372; 2008.
Martinez-Benitez, B. Características morfológicas de la enfermedad intestinal inflamatoria idiopática. En: Yamamoto-Furusho, JK. Enfermedad Inflamatoria Intestinal: Aspectos básicos y clínicos.2010; México, D.F: Alfil
Villeda-Ramirez M.A. Etiopatogenia de la enfermedad inflamatoria intestinal. En: Yamamoto-Furusho, JK.. Enfermedad Inflamatoria Intestinal: Aspectos básicos y clínicos. 2010; México, D.F: Alfil
World Healh Organization. National policy on traditional medicine and regulation of herbal medicines .Report of a WHO global survey. Geneve 2005
Wild GE, Drozdowski L, Tartaglia C, Clandinin MT, Thomson AB. Nutritional modulation of the inflammatory response in inflammatory bowel disease--from the molecular to the integrative to the clinical. World J Gastroenterol. 2007 Jan 7;13(1):1-7. doi: 10.3748/wjg.v13.i1.1.
PubMed 17206749Atherton P. Aloe vera revisited. British Journal of Phytotherapy 1998; 4(4): 176-183.
Holdsworth DK. Chromones in aloe species. I. Aloesin--a C-glucosyl-7-hydroxychromone. Planta Med. 1971 Apr;19(4):322-5. doi: 10.1055/s-0028-1099649. No abstract available.
PubMed 5573544Siddharthan K. Health insurance coverage of the immigrant elderly. Inquiry. 1991 Winter;28(4):403-12.
PubMed 1761313Avila H, Rivero J, Herrera F, Fraile G. Cytotoxicity of a low molecular weight fraction from Aloe vera (Aloe barbadensis Miller) gel. Toxicon. 1997 Sep;35(9):1423-30. doi: 10.1016/s0041-0101(97)00020-2.
PubMed 9403965Curciarello J, De Ortuzar S, Borzi S, Bosia D. [Severe acute hepatitis associated with intake of Aloe vera tea]. Gastroenterol Hepatol. 2008 Aug-Sep;31(7):436-8. doi: 10.1157/13125590. Spanish.
PubMed 18783689Bottenberg MM, Wall GC, Harvey RL, Habib S. Oral aloe vera-induced hepatitis. Ann Pharmacother. 2007 Oct;41(10):1740-3. doi: 10.1345/aph.1K132. Epub 2007 Aug 28.
PubMed 17726067Rabe C, Musch A, Schirmacher P, Kruis W, Hoffmann R. Acute hepatitis induced by an Aloe vera preparation: a case report. World J Gastroenterol. 2005 Jan 14;11(2):303-4. doi: 10.3748/wjg.v11.i2.303.
PubMed 15633238
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aloe Vera in the Inflammation of Patients With Mild Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01783119
- Acronym / sponsor ID
- AVIUC / REF.589
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative Colitis, Aloe Vera
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Institute of Medical Sciences and Nutrition, Salvador ZubiranUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Ulcerative Colitis (UC) belongs to the group of diseases called Inflammatory Bowel Disease (IBD) which is characterized by a chronic ulceration of the colon. The conventional treatment can have adverse effects and does not guarantee effectiveness in some patients requiring aggressive therapy using adjuvant therapy Aloe vera has been shown to have a beneficial effect in different disease, and have an anti-inflammatory effect in UC patients. Objective: Measuring the effect of the consumption of 200 ml of aloe vera gel daily for a period of three months, in the degree of inflammation in patients with mild UC based on Mayo scale and quantification of IL-6 in the colonic mucosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aloe Vera | Experimental | Dietary Supplement: Aloe Barbadensis MillerConsume 200 ml of aloe vera gel per day over a period of three months |
| water | Placebo comparator | Dietary Supplement: placebo waterConsume 200 ml of placebo per day over a period of three months |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aloe Barbadensis Miller | Dietary supplement | Aloe Vera |
| placebo water | Dietary supplement | water |
Primary outcome
Full Mayo Score
Time frame: 3 months
Interleukine - 6
Time frame: 3 months
Quantification in mucosal Biopsy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
- Background: PubMed 22001864Molodecky NA, Soon IS, Rabi DM, Ghali WA, Ferris M, Chernoff G, Benchimol EI, Panaccione R, Ghosh S, Barkema HW, Kaplan GG. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012 Jan;142(1):46-54.e42; quiz e30. doi: 10.1053/j.gastro.2011.10.001. Epub 2011 Oct 14.
- Background: PubMed 21592901Bosques-Padilla FJ, Sandoval-Garcia ER, Martinez-Vazquez MA, Garza-Gonzalez E, Maldonado-Garza HJ. [Epidemiology and clinical characteristics of ulcerative colitis in north-eastern Mexico]. Rev Gastroenterol Mex. 2011 Jan-Mar;76(1):34-8. Spanish.
- Background: PubMed 18402220[Clinical guidelines for the diagnosis and treatment of chronic ulcerative colitis (CUC). Diagnosis. Usefulness of clinical data and laboratory analysis]. Rev Gastroenterol Mex. 2007 Jul-Sep;72(3):298-9. No abstract available. Spanish.
- BackgroundLópez-Rosés L, Olivencia-Palomar P. Colonoscopia. Rev. esp. enferm. dig. 100(6): 372-372; 2008.
- BackgroundMartinez-Benitez, B. Características morfológicas de la enfermedad intestinal inflamatoria idiopática. En: Yamamoto-Furusho, JK. Enfermedad Inflamatoria Intestinal: Aspectos básicos y clínicos.2010; México, D.F: Alfil
- BackgroundVilleda-Ramirez M.A. Etiopatogenia de la enfermedad inflamatoria intestinal. En: Yamamoto-Furusho, JK.. Enfermedad Inflamatoria Intestinal: Aspectos básicos y clínicos. 2010; México, D.F: Alfil
- BackgroundWorld Healh Organization. National policy on traditional medicine and regulation of herbal medicines .Report of a WHO global survey. Geneve 2005
- Background: PubMed 17206749Wild GE, Drozdowski L, Tartaglia C, Clandinin MT, Thomson AB. Nutritional modulation of the inflammatory response in inflammatory bowel disease--from the molecular to the integrative to the clinical. World J Gastroenterol. 2007 Jan 7;13(1):1-7. doi: 10.3748/wjg.v13.i1.1.
- BackgroundAtherton P. Aloe vera revisited. British Journal of Phytotherapy 1998; 4(4): 176-183.
- Background: PubMed 5573544Holdsworth DK. Chromones in aloe species. I. Aloesin--a C-glucosyl-7-hydroxychromone. Planta Med. 1971 Apr;19(4):322-5. doi: 10.1055/s-0028-1099649. No abstract available.
- Background: PubMed 1761313Siddharthan K. Health insurance coverage of the immigrant elderly. Inquiry. 1991 Winter;28(4):403-12.
- Background: PubMed 9403965Avila H, Rivero J, Herrera F, Fraile G. Cytotoxicity of a low molecular weight fraction from Aloe vera (Aloe barbadensis Miller) gel. Toxicon. 1997 Sep;35(9):1423-30. doi: 10.1016/s0041-0101(97)00020-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesús K Yamamoto-Furusho, MD, PhD study chair
INCMNSZ
Lizzette C Alfaro principal investigator
INCMNSZ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Aloe Barbadensis Miller in people with Ulcerative Colitis, run by National Institute of Medical Sciences and Nutrition, Salvador Zubiran at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jesús K. Yamamoto-Furusho, PhD,MD (+5554870900 ext. 2710, kazuofurusho@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full Mayo Score (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01783119, which also lists 38 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2013.