Aphtostomatitis and Mucositis Treatment by Natural Herbal... | NCT01321307

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

NCT01321307

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Mar 23, 2011Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Aphtostomatitis
Mucositis

Interventions

Not provided

Countries

Israel

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

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 22, 2011

First Submission Date that Met QC Criteria

Mar 22, 2011

First Posted Date

Mar 23, 2011Estimated

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

Mar 22, 2011

Last Update Posted Date

Mar 23, 2011Estimated

Name	Class
R&T Health Products Ltd.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Herpetic aphtomatitis
Bacterial aphtostomatitis
Viral aphtostomatitis
Fungal aphtostomatitis

Exclusion Criteria:

Oncology patients
Systematic diseases (Colitis, Crohn, diabetes, Behcet)
Pregnancy
Arthritis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Community population care

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Galit Avior, MD	Contact	972-4-630-4846

Overall Officials

Name	Affiliation	Role
Galit Avior, MD	Hillel Yaffe Medical Center, Hadera, Israel	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe MC, Otolaryngology - Head & Neck Surgery Unit		Hadera		38100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D052016	Mucositis
D019226	Oral Ulcer

Ancestor Terms

ID	Term
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D009059	Mouth Diseases

Browse Leaves

Not provided

Browse Branches

Not provided