Monitoring of Allergic and Asthmatic Symptoms in Patients... | NCT01684137

Studies
Monitoring of Allergic and Asthmatic Symptoms in Patients Taking Dietary Supplements Joalis Bambi Bronchi and Joalis Bambi Analerg

NCT01684137

Sponsor

DSC Services, s.r.o.

Status

Unknown status

Last Update Posted

Sep 12, 2012Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Children

Interventions

Joalis Bambi Analerg
Joalis Bambi Bronchi
Placebo
Placebo

Countries

Czechia

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

Sep 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Aug 2013Estimated

Completion Date

Not provided

First Submitted Date

Aug 21, 2012

First Submission Date that Met QC Criteria

Sep 10, 2012

First Posted Date

Sep 12, 2012Estimated

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

Sep 10, 2012

Last Update Posted Date

Sep 12, 2012Estimated

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

Reduction of the total IgE antibody, improved vital capacity and lung volume measured by spirometry.

Improving quality of life observed in the visual analogue scale (VAS).

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Joalis Bambi Bronchi & Joalis Bambi Analerg	Active Comparator	10 days, 2 times per day 2,5/5 ml	Dietary Supplement: Joalis Bambi Analerg Dietary Supplement: Joalis Bambi Bronchi
Placebo & Placebo	Placebo Comparator	10 days, 2 times per day 2,5/5 ml	Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Joalis Bambi Analerg	Dietary Supplement		Joalis Bambi Bronchi & Joalis Bambi Analerg
Joalis Bambi Bronchi

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction of the total IgE (IU/ml) antibody.		1 year
Improving of vital capacity measured by spirometry (litre).		1 year
Improving of lung volume measured by spirometry (litre).		1 year

Secondary Outcomes

Measure	Description	Time Frame
Improving of quality of life observed in the visual analogue scale (VAS).		1 year

Other Outcomes

Measure	Description	Time Frame
Asthma bronchiale, age 9-18 year		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

subjects with confirmed Asthma bronchiale I-III. degrees in possible combination with other allergic symptoms treating with classic pharmacological treatment
9-18 years
signed Infromed Conset

Exclusion Criteria:

subjects who have previously used a food suplemts Joalis
subjects with known intolerance or hypersensitivity to the components of food supplements
subjects with alcohol abuse or drugs at the time of recruitment into the study
subjects enrolled in another clinical trial in the last 1 month before enrollment in this study
subjects in a situation which in the opinion of a doctor may interfere with optimal participation in the study or can pose a risk to the subjects
pregnant girls, lactating girls and girls of childbearing age without adequate contraception

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Karel Chroust, RNDr., Ing., PhD..	Contact	+420 777 826 208		chroust@dscservices.cz

Overall Officials

Name	Affiliation	Role
Karel Chroust, RNDr., Ing., PhD.	DSC Services, s.r.o.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alergologická ambulance	Recruiting	Zlín		760 01	Czechia