Botanical Therapy for Acute Viral Respiratory Infections

NCT07805447 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: ANMC-DPBT-AVRI-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dynamic Pathology-Based Therapy; DPBT; Host Pathology-Directed Therapy; Botanical Therapy; Botanical Medicine; Acute Viral Respiratory Infection; Host-Directed Therapy; Respiratory Virus

Outcome Measures

Primary Outcomes (2)

• Feasibility of DPBT Protocol Implementation

  Proportion of enrolled participants who complete the assigned DPBT treatment and required study assessments according to the protocol.

  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.

  Day 0 through Day 12

Study Arms (1)

DPBT Botanical Therapy

EXPERIMENTAL

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.

Drug: PurInf I Botanical Formulation; Drug: PurInf II Botanical Formulation; Drug: PurInf III Botanical Formulation; Drug: PurCo Botanical Formulation; Drug: PurPhl Botanical Formulation; Drug: PurClo Botanical Formulation

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.

DPBT Botanical Therapy

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.

DPBT Botanical Therapy

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.

DPBT Botanical Therapy

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.

DPBT Botanical Therapy

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.

DPBT Botanical Therapy

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.

DPBT Botanical Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• All Natural Medicine Clinic, LLC: lead

Study Sites (1)

All Natural Medicine Clinic, LLC

Rockville, Maryland, 20852, United States

Location

Study Officials

• Wanzhu Hou, L.Ac., CH., CMD, MD (CN)

  All Natural Medicine Clinic, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wanzhu Hou, l.Ac., CH, CMD, MD(CN)

CONTACT

1(301)770-4480; TCM@anmedicine.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, single-group, open-label feasibility study. All participants will receive the DPBT intervention in addition to medically appropriate standard care. Within the single study group, a predefined clinical algorithm will identify each participant's host pathological state or combination of states and assign the corresponding botanical formulation module or combination of modules. Treatment may be adjusted according to protocol-defined clinical reassessment. There is no separate control or comparison group

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 4, 2026
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: September 4, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication of the primary study results and available for 5 years.
• Access Criteria: De-identified individual participant data will be made available to qualified researchers upon reasonable request. Requests should include a research proposal describing the intended use of the data and will be reviewed for scientific purpose and compliance with participant consent, privacy protections, and applicable IRB requirements. Data will be provided following approval of the request and, when appropriate, execution of a data use agreement.

Locations

US (1)