Respiratory DiseasesEarly Phase 1NCT06267859
Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children
A Early Phase 1 study testing The use of a combination of microelements and vitamins against the background of physiotherapy in people with Respiratory Diseases and Congenital Heart Defects, run by Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan at 1 site in Uzbekistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 days to 15 years
- Conditions the study is for
- Respiratory Diseases, Congenital Heart Defects
- What is being tested?
- The use of a combination of microelements and vitamins against the background of physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUzbekistan
- Study dates
- 8 Nov 2023to 30 Jan 2034
- Phase
- Early Phase 1
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 3 days to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children from birth to 15 years;
- children permanently residing in the territory where the clinical examination is carried out;
- children with acute bronchitis;
- children included in the group of "frequently ill children";
- patients without severe chronic diseases.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uzbekistan1 site
Turdieva Shokhida Tolkunovna
Tashkent, Yunus-obad District, 100140
About this study
Official title: Clinical Characterization of Leading Somatic Pathologies in Pediatric Patients: Optimizing Treatment and Medical Rehabilitation Strategies
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 the most frequently diagnosed bronchopulmonary (acute bronchitis with and without obstruction, congenital pneumonia, acute and chronic pneumonia) and cardiovascular diseases in 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.
Read the detailed description
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:
- children from birth to 15 years;
- children permanently residing in the territory where the clinical examination is carried out;
- full-term newborns with congenital pneumonia without severe complications;
- children with acute bronchitis with airway obstruction;
- children with acute pneumonia without complications;
- 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.
Clinical research methods:
- Collection of anamnestic data;
- General examination of patients (auscultation, palpation, percussion);
- If necessary: consultation with a geneticist and pediatric doctors of various specialties (cardiologist, surgeon, urologist, nephrologist, otolaryngologist, pulmonologist, immunologist, allergist)
- Standard laboratory tests (general analysis of blood, urine, feces);
- Standard biochemical studies (microelements of blood and enzymes in venous blood);
- Instrumental studies: chest X-ray, ultrasound examination of internal organs (chest and abdominal organs), computed tomography (chest and abdominal organs);
- Studies of enzymatic activity and protease-anti protease imbalance in children in induced bronchial fluid (TTLA, NE, MMP-8, MMP-9, CatG, CatB, CatD, CatL, AAT, A2M, SLPI, TIMP-1).
- Study of immunological status (cellular immunity, according to standard methods); Immunological research methods - flow cytometry, mIU/mL: immunogram - CD3, CD3/4, CD3/8, CD19, CD16/56, CD3/16/56, CD3/HLA-; and others;
- Study of antioxidant status (TAS, using the PSR method, mmol/L);
- Assessing the quality of life of patients (methods: PedsQLtm 4.0; HBSC, indicator: total score on the screening survey).
- Conditions
- Respiratory Diseases, Congenital Heart Defects
- Being tested
- The use of a combination of microelements and vitamins against the background of physiotherapy
- Keywords
- children, adolescents, heart diseases, lung diseases, congenital malformations, acute bronchitis
- Medical subject headings
- Respiratory Tract Diseases, Heart Defects, Congenital, Heart Diseases, Lung Diseases, Congenital Abnormalities, Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The use of a combination of microelements and vitamins against the background of physiotherapyCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| First stage | No intervention | 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. |
| Second stage | No intervention | Study the effectiveness of treatment according to approved treatment standards |
| third stage | No intervention | Based on the research results, develop your treatment tactics. It is approved by the Ethics Committee for working with patients. |
| fourth stage | Experimental | Use your treatment tactics among a group of patients. Study the effectiveness of the proposed therapy and rehabilitation methods. Receives: Combination Product: The use of a combination of microelements and vitamins against the background of physiotherapy |
| fifth stage | No intervention | Based on the research data, clinical recommendations for doctors will be developed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start8 Nov 2023
- Primary completion30 Jan 2032 (estimated)
- Study completion30 Jan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DiseasesStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Identification of children from the group of "frequently ill children"; Development of non-invasive diagnostics for respiratory biofilm in children; Development of enzymatic bronchial cleansing in children.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Turdieva Shokhida Tolkunovna, MD, Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
- Investigators
- Shokhida T Turdieva, D.Sc., Principal investigator, Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267859
- Sponsor's protocol ID
- No. 2 of 2023/11/7
- Status last verified
- Aug 2026
- First submitted
- 20 Dec 2023
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.