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Aphtostomatitis and Mucositis Treatment by Natural Herbal Formula (Sorend®)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2011 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01321307
First Posted: March 23, 2011
Last Update Posted: March 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
R&T Health Products Ltd.
Information provided by:
Hillel Yaffe Medical Center
  Purpose
Sorend is a water-based formula, which contains carob, melissa and sage. Elder inhabitants of Israel are known to use carob extract to ease sores in the mouth, due to the tannins which create a complex with various proteins and polysaccharides, thus creating an impenetrable layer covering the sores, allowing spontaneous healing.

Condition
Aphtostomatitis Mucositis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Aphtostomatitis and Mucositis Treatment by Natural Herbal Formula (Sorend®)

Further study details as provided by Hillel Yaffe Medical Center:

Estimated Enrollment: 120
Study Start Date: April 2011
Groups/Cohorts
Sorend
Group no. 1 shall receive Sorend following diagnosis of aphtostomatitis or mucositis.
Sorend placebo
Group no. 2 shall receive Sorend placebo following diagnosis of aphtostomatitis or mucositis.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Community population care
Criteria

Inclusion Criteria:

  • Herpetic aphtomatitis
  • Bacterial aphtostomatitis
  • Viral aphtostomatitis
  • Fungal aphtostomatitis

Exclusion Criteria:

  • Oncology patients
  • Systematic diseases (Colitis, Crohn, diabetes, Behcet)
  • Pregnancy
  • Arthritis
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321307


Contacts
Contact: Galit Avior, MD 972-4-630-4846

Locations
Israel
Hillel Yaffe MC, Otolaryngology - Head & Neck Surgery Unit Not yet recruiting
Hadera, Israel, 38100
Principal Investigator: Galit Avior, MD         
Sponsors and Collaborators
Hillel Yaffe Medical Center
R&T Health Products Ltd.
Investigators
Principal Investigator: Galit Avior, MD Hillel Yaffe Medical Center, Hadera, Israel
  More Information

Responsible Party: Galit Avior, MD, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01321307     History of Changes
Other Study ID Numbers: 91-2010-HYMC
First Submitted: March 22, 2011
First Posted: March 23, 2011
Last Update Posted: March 23, 2011
Last Verified: March 2011

Keywords provided by Hillel Yaffe Medical Center:
Aphtostomatitis
Mucositis
Mouth sores
Natural
Herbal

Additional relevant MeSH terms:
Mucositis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases