An Early Phase 1 interventional study of The use of a combination of microelements and vitamins against the background of physiotherapy in Respiratory Diseases and Congenital Heart Defects, sponsored by Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan. Enrolling by invitation at 1 site in Uzbekistan. Open to participants aged 3 Days to 15 Years. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan · Early Phase 1, Interventional, and Supportive care
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:
Children's health is a priority in modern medicine. Some childhood diseases are most often encountered in the practice of pediatricians and family doctors. Children with these diseases need early diagnosis, treatment, and rehabilitation.
Patient selection criteria are:
Exclusion criteria:
Clinical research methods:
410 studies on the registry are indexed under Respiratory Tract Diseases; 59 are open to participants now.
This study's planned enrollment of 600 is above the median of 117 across 316 interventional studies indexed under Respiratory Tract Diseases.
Browse Respiratory Tract Diseases studies →Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
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children permanently residing in the territory where the clinical examination is carried out;
- children with acute bronchitis;
Exclusion Criteria:
Study of children from the group of "frequently ill children", and with congenital diseases, collection of anamnesis, their examination, clinical and laboratory examination. Purpose: to identify the most frequently encountered group of diseases among children.
Study the effectiveness of treatment according to approved treatment standards
Based on the research results, develop your treatment tactics. It is approved by the Ethics Committee for working with patients.
Use your treatment tactics among a group of patients. Study the effectiveness of the proposed therapy and rehabilitation methods.
Combination Product: The use of a combination of microelements and vitamins against the background of physiotherapy
Based on the research data, clinical recommendations for doctors will be developed.
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.
Working with archival documentation.
Medical and statistical analysis of data from children's medical institutions is carried out to identify common somatic diseases in children from birth to 15 years old associated with impaired immunity. Evaluation criterion: * medical archival documentation of children's clinics in the region; * statistical analysis of archival documentation on the morbidity of children (acute respiratory: acute bronchitis and acute pneumonia; cardiovascular diseases: congenital heart disease, congenital and acquired carditis).
Time frame: one year
Formation of a group of patients to study immunity and the antioxidant system in venous blood.
Objective: Preparations for a clinical trial are underway. Work in progress: * 400 children with diseases of the bronchopulmonary system and congenital heart defects will be selected; * preparation and submission to the Ethics Committee under the Ministry of Health of Uzbekistan of all necessary documentation for the planned clinical trial among children; Evaluation criterion: \- The percentage of detection of acute bronchopulmonary and congenital heart defects in the region of residence (results of medical statistics).
Time frame: one year
Clinical scientific research.
A clinical study of sick children (acute respiratory: acute bronchitis and acute pneumonia; cardiovascular diseases: congenital heart disease, congenital and acquired carditis) is being conducted to determine the presence of immunological and antioxidant blood parameters. Work in progress: * Screening medical examination of children (objective examination, general blood test - ELISA method); * Examination of venous blood for indicators of immune status (extended immunogram: CD3, CD3/4, CD3/8, CD19, and others), method: flow cytometry of venous blood, mIU/mL; * the study of antioxidant status in sick children (Total antioxidant status, method: venous blood PCR, mmol/L); * publication of the research results. Evaluation criterion: * opinion of reviewers and experts in this field (comparison of the results obtained by other scientists - immunological and antioxidant research) * changes in immune and antioxidant status indicators in sick children to healthy peers.
Time frame: five years.
Clinical trial evaluation.
The development and implementation of clinical recommendations for practicing pediatricians, pediatric pulmonologists, and cardiologists on improving children's health with acute respiratory (acute bronchitis, pneumonia) and cardiovascular (CHD, congenital and acquired carditis) diseases. Work in progress: * development and implementation of clinical recommendations for pediatricians, pediatric pulmonologists, and cardiologists; * assessment of the effectiveness of clinical recommendations based on repeated laboratory tests (immunological (flow cytometry, mIU/mL) and TAS (PCR, mmol/L)), after six months of implementation of the recommendations. Evaluation criterion: * opinion of reviewers and experts - review; * assessing the quality of life of patients (methods: PedsQLtm 4.0; HBSC), indicator: total score on the screening survey; * number of recurrent illnesses and complications, indicator: the number of patients as a percentage.
Time frame: three years
Plan to share: Yes — This clinical study aims to discover the course of common congenital, infectious, and non-infectious diseases among children living in Uzbekistan, to develop methods for their treatment and improvement. Several separate clinical studies by young scientists will be combined.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: 2034/01/30
Access criteria: Researchers at the Tashkent Pediatric Medical Institute.
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Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan