Development and Evaluation of a Host Pathologic State-Directed Botanical Therapeutic Platform Technology for Acute Viral Respiratory Infection
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Feasibility of DPBT Protocol Implementation
研究概览
简要总结
This Phase 1 study will evaluate the feasibility and safety of implementing a host pathologic state-directed botanical therapeutic platform in adults with acute viral respiratory infections. The platform, called Dynamic Pathology-Based Therapy (DPBT), uses a predefined clinical algorithm to identify participants' pathological states and select the corresponding botanical formulation module or combination of modules.
Approximately 30 adults aged 18 to 80 will participate in this prospective, single-group, open-label study. All participants will receive the assigned DPBT intervention in addition to medically appropriate standard care. Treatment will generally continue for 7 days and may be extended through Day 10 if predefined pathological states persist. Study assessments will examine protocol implementation, recruitment and retention, adherence, treatment tolerability, adverse events, changes in symptoms and recovery, and exploratory changes in viral detection through Day 12.
详细描述
This Phase 1 study is a prospective, single-group, open-label feasibility study enrolling approximately 30 adults aged 18 to 80 with acute viral respiratory infections. The study will evaluate the feasibility and safety of implementing a host pathologic state-directed botanical therapeutic platform using a predefined Dynamic Pathology-Based Therapy (DPBT) clinical algorithm.
DPBT is designed to select treatment according to predefined host pathological states rather than solely according to viral identity. Eligible infections may include influenza, respiratory syncytial virus, COVID-19, adenovirus, parainfluenza virus, human metapneumovirus, rhinovirus, or another clinically compatible acute viral respiratory infection. Viral identification testing will be performed when feasible and medically appropriate.
At baseline, participants will undergo eligibility assessment, clinical evaluation, characterization of predefined pathological states, and viral identification testing. Based on each participant's presenting pathological state or combination of states, the corresponding botanical formulation module or combination of modules will be assigned according to the predefined DPBT treatment algorithm. All participants will receive the study intervention in addition to medically appropriate standard care.
Treatment will generally continue for 7 days. Participants will be clinically reassessed during treatment and on Day 7. If predefined pathological states persist, treatment may be extended through Days 8 to 10 according to the protocol. Follow-up viral identification testing will be performed on Day 12 when a respiratory virus was detected at baseline, and repeat testing is feasible.
The primary objectives are to assess the feasibility of implementing the DPBT clinical algorithm and to evaluate safety and tolerability. Feasibility assessments will include recruitment, retention, protocol adherence, completion of required assessments, correct application of the treatment algorithm, and completeness of study data. Safety assessments will include adverse events, serious adverse events, treatment interruptions, discontinuations, and clinical tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-80 years.
- •Presence of an acute viral respiratory infection or clinical presentation consistent with an acute viral respiratory infection.
- •Onset of acute respiratory symptoms within a predefined period before enrollment.
- •Presence of one or more predefined pathological states eligible for treatment according to the DPBT clinical algorithm.
- •Able and willing to comply with study treatment, clinical assessments, and viral testing.
- •Able to understand the study requirements and provide written informed consent.
排除标准
- •Severe or life-threatening illness requiring immediate hospitalization or emergency medical treatment at enrollment.
- •Known allergy, hypersensitivity, or clinically significant intolerance to any ingredient in the botanical formulations that may be administered.
- •Pregnancy or breastfeeding.
- •Significant medical condition that, in the investigator's judgment, would make participation unsafe or interfere with interpretation of study outcomes.
- •Current participation in another interventional clinical trial that could interfere with this study.
- •Unable or unwilling to comply with study procedures or provide informed consent.
研究组 & 干预措施
DPBT Botanical Therapy
Participants in this single experimental arm will receive host pathologic state-directed botanical therapy using the predefined Dynamic Pathology-Based Therapy (DPBT) clinical algorithm, in addition to medically appropriate standard care. Based on the participant's presenting pathological state or combination of states, the algorithm will assign one or more of six botanical formulation modules: PurInf I for an upper-respiratory inflammatory state, PurInf II for a fever-predominant state, PurInf III for a lower-respiratory inflammatory state, PurCo for a cough-predominant state, PurPhl for a pathological-secretions state, and PurClo for a clot- and poor-circulation-related state. Assigned modules may be continued, added, removed, or discontinued according to protocol-defined reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if predefined pathological states persist.
干预措施: PurInf I Botanical Formulation (Drug)
DPBT Botanical Therapy
Participants in this single experimental arm will receive host pathologic state-directed botanical therapy using the predefined Dynamic Pathology-Based Therapy (DPBT) clinical algorithm, in addition to medically appropriate standard care. Based on the participant's presenting pathological state or combination of states, the algorithm will assign one or more of six botanical formulation modules: PurInf I for an upper-respiratory inflammatory state, PurInf II for a fever-predominant state, PurInf III for a lower-respiratory inflammatory state, PurCo for a cough-predominant state, PurPhl for a pathological-secretions state, and PurClo for a clot- and poor-circulation-related state. Assigned modules may be continued, added, removed, or discontinued according to protocol-defined reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if predefined pathological states persist.
干预措施: PurInf II Botanical Formulation (Drug)
DPBT Botanical Therapy
Participants in this single experimental arm will receive host pathologic state-directed botanical therapy using the predefined Dynamic Pathology-Based Therapy (DPBT) clinical algorithm, in addition to medically appropriate standard care. Based on the participant's presenting pathological state or combination of states, the algorithm will assign one or more of six botanical formulation modules: PurInf I for an upper-respiratory inflammatory state, PurInf II for a fever-predominant state, PurInf III for a lower-respiratory inflammatory state, PurCo for a cough-predominant state, PurPhl for a pathological-secretions state, and PurClo for a clot- and poor-circulation-related state. Assigned modules may be continued, added, removed, or discontinued according to protocol-defined reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if predefined pathological states persist.
干预措施: PurInf III Botanical Formulation (Drug)
DPBT Botanical Therapy
Participants in this single experimental arm will receive host pathologic state-directed botanical therapy using the predefined Dynamic Pathology-Based Therapy (DPBT) clinical algorithm, in addition to medically appropriate standard care. Based on the participant's presenting pathological state or combination of states, the algorithm will assign one or more of six botanical formulation modules: PurInf I for an upper-respiratory inflammatory state, PurInf II for a fever-predominant state, PurInf III for a lower-respiratory inflammatory state, PurCo for a cough-predominant state, PurPhl for a pathological-secretions state, and PurClo for a clot- and poor-circulation-related state. Assigned modules may be continued, added, removed, or discontinued according to protocol-defined reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if predefined pathological states persist.
干预措施: PurCo Botanical Formulation (Drug)
DPBT Botanical Therapy
Participants in this single experimental arm will receive host pathologic state-directed botanical therapy using the predefined Dynamic Pathology-Based Therapy (DPBT) clinical algorithm, in addition to medically appropriate standard care. Based on the participant's presenting pathological state or combination of states, the algorithm will assign one or more of six botanical formulation modules: PurInf I for an upper-respiratory inflammatory state, PurInf II for a fever-predominant state, PurInf III for a lower-respiratory inflammatory state, PurCo for a cough-predominant state, PurPhl for a pathological-secretions state, and PurClo for a clot- and poor-circulation-related state. Assigned modules may be continued, added, removed, or discontinued according to protocol-defined reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if predefined pathological states persist.
干预措施: PurPhl Botanical Formulation (Drug)
DPBT Botanical Therapy
Participants in this single experimental arm will receive host pathologic state-directed botanical therapy using the predefined Dynamic Pathology-Based Therapy (DPBT) clinical algorithm, in addition to medically appropriate standard care. Based on the participant's presenting pathological state or combination of states, the algorithm will assign one or more of six botanical formulation modules: PurInf I for an upper-respiratory inflammatory state, PurInf II for a fever-predominant state, PurInf III for a lower-respiratory inflammatory state, PurCo for a cough-predominant state, PurPhl for a pathological-secretions state, and PurClo for a clot- and poor-circulation-related state. Assigned modules may be continued, added, removed, or discontinued according to protocol-defined reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if predefined pathological states persist.
干预措施: PurClo Botanical Formulation (Drug)
结局指标
主要结局
Feasibility of DPBT Protocol Implementation
时间窗: Through Day 12
Proportion of enrolled participants who complete the assigned DPBT treatment and required study assessments according to the protocol.
Safety and Tolerability of DPBT Treatment
时间窗: Day 0 through Day 12
Number and proportion of participants experiencing adverse events and serious adverse events, including treatment-related adverse events, treatment interruptions, and treatment discontinuations.
次要结局
未报告次要终点