Botanical Therapy for Acute Viral Respiratory Infections

Conditions

• Acute Viral Respiratory Infection

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• PurInf I Botanical Formulation — DRUG
  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.
• PurInf II Botanical Formulation — DRUG
  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.
• PurInf III Botanical Formulation — DRUG
  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.
• PurCo Botanical Formulation — DRUG
  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.
• PurPhl Botanical Formulation — DRUG
  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.
• PurClo Botanical Formulation — DRUG
  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.

Study Details

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.

Key Dates

First listed

Sep 4, 2026

Start date

Jul 1, 2027

Status verified

Sep 2026

Primary completion

Jun 30, 2028

Completion

Jun 30, 2028

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: 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.

Primary Outcome Measure

Feasibility of DPBT Protocol Implementation [ Time Frame: Through Day 12 ]

Central Contacts

• Wanzhu Hou, l.Ac., CH, CMD, MD(CN)
  1(301)770-4480
  [email protected]

Locations (1)

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