AphtostomatitisNCT01321307
Aphtostomatitis and Mucositis Treatment by Natural Herbal Formula (Sorend®)
An observational study of Aphtostomatitis and Mucositis, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Aphtostomatitis, Mucositis
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2011to not given
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community population care
Who may be able to join
- Herpetic aphtomatitis
- Bacterial aphtostomatitis
- Viral aphtostomatitis
- Fungal aphtostomatitis
Who cannot join
- Oncology patients
- Systematic diseases (Colitis, Crohn, diabetes, Behcet)
- Pregnancy
- Arthritis
Trial locations and contacts
1 site in 1 country.
Galit Avior, MD contact
Israel1 site
Hillel Yaffe MC, Otolaryngology - Head & Neck Surgery Unit
Hadera, 38100
Galit Avior, MD
About this study
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.
- Conditions
- Aphtostomatitis, Mucositis
- Keywords
- Aphtostomatitis, Mucositis, Mouth sores, Natural, Herbal
- Medical subject headings
- Mucositis, Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphtostomatitisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Collaborators
- R&T Health Products Ltd.
- Investigators
- Galit Avior, MD, Principal investigator, Hillel Yaffe Medical Center, Hadera, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321307
- Sponsor's protocol ID
- 91-2010-HYMC
- Status last verified
- Mar 2011
- First submitted
- 22 Mar 2011
- Last updated
- 23 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aphtostomatitis and Mucositis Treatment by Natural Herbal Formula (Sorend®)
- ClinicalTrials.gov ID
- NCT01321307
- Acronym / sponsor ID
- 91-2010-HYMC
- Conditions
- Aphtostomatitis, Mucositis
- Keywords
- Aphtostomatitis, Mucositis, Mouth sores, Natural, Herbal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Collaborators
- R&T Health Products Ltd.
- Study start
- Apr 2011
- First posted
- 23 Mar 2011 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community population care
Key inclusion criteria (4 listed)
- Herpetic aphtomatitis
- Bacterial aphtostomatitis
- Viral aphtostomatitis
- Fungal aphtostomatitis
Key exclusion criteria (4 listed)
- Oncology patients
- Systematic diseases (Colitis, Crohn, diabetes, Behcet)
- Pregnancy
- Arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
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.
Galit Avior, MD contact
Galit Avior, MD principal investigator
Hillel Yaffe Medical Center, Hadera, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aphtostomatitis and Mucositis, run by Hillel Yaffe Medical Center at 1 site in Israel.
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 4 inclusion and 4 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 23 Mar 2011. 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 Israel. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Galit Avior, MD (972-4-630-4846), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 23 Mar 2011.