All Natural Medicine Clinic, LLC
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.
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, adeno…
Inclusion Criteria * 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. Exclusion Criteria * Severe or life-threa…
A proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with an upper respiratory inflammatory pathological state. PurInf I may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol.
A proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with a fever-predominant pathological state. PurInf II may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol.
A proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with a lower respiratory inflammatory pathological state. PurInf III may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol.
A proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with a cough-predominant pathological state. PurCo may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol.
A proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with a pathological-secretions state. PurPhl may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol.
A proprietary oral multi-ingredient botanical formulation module assigned through the predefined DPBT clinical algorithm for participants with a clot- and poor-circulation-related pathological state. PurClo may be administered alone or in combination with other DPBT formulation modules according to protocol-defined assessment and reassessment. Treatment will generally continue for 7 days and may be extended through Day 10 if the corresponding pathological state persists. Administration, adherence, treatment modification, interruption, and discontinuation will be documented according to the study protocol.
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