Clinical trial
Based on Medical Statistical Analysis and Screening (Dispensary) Examination, Identification of the Most Common Somatic and Congenital Diseases in Children, With the Further Development of More Effective Methods of Treatment and Recovery
Name
No. 2 of 2023/11/7
Description
The goal of the clinical study is to clarify the course of common congenital, infectious, and non-infectious diseases in children living in Uzbekistan, and to develop methods for their treatment and rehabilitation.
The main questions it aims to answer:
* Analysis of common congenital diseases among children;
* Analysis of commonly diagnosed bronchopulmonary and cardiovascular diseases among children;
* Based on the results of the primary research, common diseases among children will be identified;
* Analysis of existing treatment methods and their effectiveness;
* Development of modern methods of treatment and rehabilitation of children.
Trial arms
Trial start
2023-11-08
Estimated PCD
2033-12-30
Trial end
2034-01-30
Status
Recruiting
Phase
Early phase I
Treatment
The use of a combination of microelements and vitamins against the background of physiotherapy
If necessary, necessary microelements and vitamins will be added to the treatment process. At the same time, physiotherapeutic procedures will be added at the rehabilitation stage.
Arms:
fourth stage
Size
110
Primary endpoint
Working with archival documentation.
one year
Formation of a group of patients to study immunity and the antioxidant system in venous blood.
one year
Clinical scientific research.
five years.
Clinical trial evaluation.
three years
Eligibility criteria
Inclusion Criteria:
* children from birth to 15 years;
* children permanently residing in the territory where the clinical examination is carried out;
* children included in the group of "frequently ill children";
* patients without severe chronic diseases.
Exclusion Criteria:
* Teenagers over 15 years old;
* Patients with severe neurological and mental diseases;
* Patients with endocrinological diseases;
* Patients with long-term chronic somatic diseases;
* Children without genetic pathologies.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'identification of children from the group of "frequently ill children"', 'primaryPurpose': 'SUPPORTIVE_CARE', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'working with children from the "frequently ill children" group', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 110, 'type': 'ESTIMATED'}}
Updated at
2024-02-28
1 organization
1 product
2 indications
Organization
Tashkent Pediatric Medical InstituteProduct
Microelements and VitaminsIndication
Respiratory DiseasesIndication
Congenital heart defects