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Completed
NCT07671508
Prophylaxis of Complications of Basic Therapy Using Naderin in Socially Significant Diseases
Conditions: Malignant Neoplasms, Tuberculosis (TB), HEPATITIS C (HCV)
Sex: All
Ages: 18 Years – 50 Years
Healthy volunteers: No
Phase: PHASE2, PHASE3
Enrollment: 75
Sponsor: MIPO Clinic
Summary
This interventional study evaluated the efficacy of Naderin (sodium nucleinate) for the prophylaxis of complications during basic therapy and medical rehabilitation in patients with socially significant diseases, including malignant neoplasms, tuberculosis, and hepatitis C. The study assessed the immunocorrective effects of Naderin on hematological parameters, the incidence of infectious complications, and clinical outcomes.
A total of 75 patients (40 in the main group and 35 in the control group) were enrolled. Patients in the main group received Naderin as an adjunct to standard therapy, while the control group received standard therapy without immunocorrection. The study demonstrated that Naderin reduced the duration of neutropenia by 4-5 days, attenuated the decline in white blood cell and lymphocyte counts during chemotherapy, and reduced the incidence of treatment interruptions due to complications. These findings suggest that Naderin may serve as an effective immunomodulatory agent for supportive care in patients with socially significant diseases.
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of malignant neoplasm, tuberculosis, or hepatitis C (confirmed by clinical, laboratory, and/or histopathological criteria)
* Age between 18 and 50 years at the time of enrollment
* Receiving standard basic therapy (chemotherapy, anti-tuberculosis therapy, or antiviral therapy) according to national clinical protocols
* Signed informed consent to participate in the study
* Willingness to comply with study procedures and follow-up visits
* ECOG performance status ≤ 2 or equivalent
Exclusion Criteria:
* Severe concomitant diseases (e.g., decompensated cardiovascular, renal, or hepatic failure) that could interfere with study participation or outcome assessment
* Known hypersensitivity or contraindications to Naderin (sodium nucleinate) or its components
* Pregnancy or lactation
* Participation in any other interventional clinical trial within 30 days prior to enrollment
* Active or uncontrolled infections (other than the primary study condition)
* Severe immunodeficiency (e.g., HIV/AIDS, advanced hematological malignancies) not related to the primary study condition
* Mental or cognitive impairment that would preclude informed consent or compliance with study procedures
* History of organ transplantation requiring immunosuppressive therapy
* Any other condition that, in the investigator's opinion, would make the participant unsuitable for the study
Source: ClinicalTrials.gov (NCT07671508). StuddyBuddy aggregates publicly available trial information.