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, 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. Exploratory assessments will examine changes in respiratory and systemic symptoms, fever, oral intake, activity level, need for additional medical care, return to usual function, and viral detection. Because this is a small, single-group feasibility study, it is not designed or statistically powered to establish definitive efficacy or to compare outcomes among different respiratory viruses.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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.
All Natural Medicine Clinic, LLC
Rockville, Maryland, United States
Feasibility of DPBT Protocol Implementation
Proportion of enrolled participants who complete the assigned DPBT treatment and required study assessments according to the protocol.
Time frame: Through Day 12
Safety and Tolerability of DPBT Treatment
Number and proportion of participants experiencing adverse events and serious adverse events, including treatment-related adverse events, treatment interruptions, and treatment discontinuations.
Time frame: Day 0 through Day 12
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