Botanical Therapy for Acute Viral Respiratory Infections

Summary

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.

Conditions

• Acute Viral Respiratory Infection

Interventions

DRUG

PurInf I Botanical Formulation

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.

DRUG

PurInf II Botanical Formulation

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.

DRUG

PurInf III Botanical Formulation

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.

DRUG

PurCo Botanical Formulation

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.

DRUG

PurPhl Botanical Formulation

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.

DRUG

PurClo Botanical Formulation

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.

Sponsors & Collaborators

• All Natural Medicine Clinic, LLC

  lead OTHER

Principal Investigators

• Wanzhu Hou, L.Ac., CH., CMD, MD (CN) · All Natural Medicine Clinic, LLC

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2027-07-01

Primary Completion

2028-06-30

Completion

2028-06-30

FDA Drug

Yes

Countries

• United States

Study Locations