Prophylaxis of Complications of Basic Therapy and Medical Rehabilitation Using Naderin in Socially Significant Diseases, Including Malignant Neoplasms, Tuberculosis, and Hepatitis C
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 主要终点
- Incidence of Infectious Complications
研究概览
简要总结
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.
详细描述
Rationale Standard treatments for malignant neoplasms, tuberculosis, and hepatitis C may be associated with clinically important complications (e.g., cytopenias, immunosuppression, infections) that can impair treatment delivery and rehabilitation. Naderin (sodium nucleinate) was evaluated as an adjunct immunomodulatory/supportive-care approach intended to improve tolerance of basic therapy and reduce complication-related disruptions.
Study Design and Setting This was a prospective, controlled, open-label interventional study conducted at clinical sites affiliated with the Kazakh National Medical University (KazNMU), Almaty, Kazakhstan, supported by KazNMU Grant 2013. Allocation to intervention vs control was non-randomized (controlled cohort comparison).
Study Population and Groups (high-level)
A total of 75 participants with one of the following diagnostic categories were enrolled: malignant neoplasms, tuberculosis, or hepatitis C. Participants were assigned to:
- Intervention group: standard-of-care therapy for the underlying condition plus Naderin (immunocorrection).
- Control group: standard-of-care therapy without Naderin. (Condition-specific eligibility criteria and any stratification by disease category should be presented in the Eligibility Criteria and Study Design/Arms sections rather than repeated here.) Intervention (high-level description) Participants in the intervention group received Naderin (sodium nucleinate) as an adjunct to standard therapy. Key intervention specifications should be captured in the Arms/Interventions module (and/or here if not elsewhere): route, dose, frequency, timing relative to basic therapy, duration, and criteria for dose modification/discontinuation, consistent with protocol reporting standards for reproducibility 1.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes assessor masked to group assignment; participants, care providers, investigators not masked (open-label)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Naderin + Standard Therapy
Participants received standard basic therapy for their underlying disease (malignant neoplasms, tuberculosis, or hepatitis C) in combination with Naderin (sodium nucleinate) as an adjunct immunocorrective therapy for the prophylaxis of complications.
干预措施: Naderin (Drug)
Standard Therapy Alone
Participants received standard basic therapy for their underlying disease (malignant neoplasms, tuberculosis, or hepatitis C) without immunocorrection.
干预措施: Standard Therapy (Other)
结局指标
主要结局
Incidence of Infectious Complications
时间窗: Up to 6 months (from study start to completion)
The number and proportion of participants who developed infectious complications (e.g., pneumonia, febrile neutropenia, bacterial infections) during the course of basic therapy (chemotherapy, anti-tuberculosis therapy, antiviral therapy).
Duration of Neutropenia
时间窗: Up to 6 months (from study start to completion)
The number of days participants experienced neutropenia (absolute neutrophil count \< 1.0 × 10⁹/L) during the course of basic therapy.
Change in White Blood Cell (WBC) and Lymphocyte Counts
时间窗: Baseline and up to 6 months
The change in white blood cell count (× 10⁹/L) and lymphocyte count (× 10⁹/L) from baseline to post-treatment assessment, comparing the Naderin group and control group.
次要结局
- Time to Recovery of Hematological Parameters(Up to 6 months)
- Adverse Events Profile(Up to 6 months)
- Duration of Hospitalization(Up to 6 months)