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Enrolling by invitationNCT06267859Updated Sep 3, 2026

Development of Methods for Effective Treatment and Improvement of Common Somatic Diseases in Children

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

Phase
Early Phase 1
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
3 Days to 15 Years
Sex
All
01

Study 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.

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).
02

Conditions studied

  • Respiratory Diseases
  • Congenital Heart Defects

Keywords

  • children
  • adolescents
  • heart diseases
  • lung diseases
  • congenital malformations
  • acute bronchitis
03

In context

Respiratory Tract Diseases

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 →

Lead sponsor

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.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Days to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

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.
05

Study design

Phase
Early Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
600 participants (estimated)

Study arms

  • No intervention
    First stage

    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.

  • No intervention
    Second stage

    Study the effectiveness of treatment according to approved treatment standards

  • No intervention
    third stage

    Based on the research results, develop your treatment tactics. It is approved by the Ethics Committee for working with patients.

  • Experimental
    fourth stage

    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

  • No intervention
    fifth stage

    Based on the research data, clinical recommendations for doctors will be developed.

Interventions

  • Combination productThe 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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

07

Study locations

1 site
  • Turdieva Shokhida Tolkunovna
    Tashkent, Yunus-obad District 100140, Uzbekistan
08

References and documents

Individual participant data

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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06267859
Lead sponsor
Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan
Responsible party
Turdieva Shokhida Tolkunovna, MD (Doctor of Medical Sciences, Professor, Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan) — Principal investigator
First posted
Feb 20, 2024
Start date
Nov 8, 2023
Primary completion
Jan 30, 2032 (estimated)
Completion
Jan 30, 2034 (estimated)
Last update
Sep 3, 2026

Study contacts

Shokhida T Turdieva, D.Sc.
principal investigator · Tashkent State Medical University (Tashkent Pediatric Medical Institute), Uzbekistan

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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