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Ancient herbal remedy put to the test against COVID-19

NCT ID NCT04810689

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This small pilot study tested whether a traditional Chinese medicine called Xuanfei Baidu granules is safe and acceptable for people with mild to moderate COVID-19. Only 10 adults were enrolled before the study was stopped early. The main goal was to see how many people would agree to join the study, not to measure how well the treatment works.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

10 people

The number who actually took part.

Started

Mar 2021

Finished

Jun 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant provides informed consent prior to initiation of any study procedures. * Individual 18 to 75 years of age. * Documentation of confirmed active SARS-CoV-2 infection, as determined by an FDA authorized molecular test conducted at any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent from any respiratory specimen collected \<96 hours prior to study entry. * Mild or Moderate COVID-19 experiencing at least one SARS-CoV-2 infection symptom including: * Mild Covid-19: Symptoms of mild illness with COVID-19 that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath or dyspnea * Moderate Covid-19: * Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion * Presence of clinical signs consistent with moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) \> 93% on room air at sea level, heart rate ≥ 90 beats per minute from a health care encounter within 48 hours. * Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period up until reaching hospitalization or 28 days, whichever is earliest. * Agrees to not utilize TCM outside of this study. * Willing to be randomized to XFBD and placebo control arm for 14 days, and followed up to 12 weeks. * Willing to comply with the study related questionnaires, procedures and measurements. * Will to not become pregnant during the 14 days of test substance ingestion using appropriate accepted methods of contraception. Acceptable methods of contraception include: postmenopausal 1 year of amenorrhea and over 50 years of age; prior tubal ligation or hysterectomy; or barrier contraception using condom or diaphragm plus spermicide. * Able to provide the identity of their health care provider or health system clinical care entry information. * Able to utilize telephone and telehealth platform to comply with the study related questionnaires, procedures and measurements. Established during the recruitment process. * Able to speak and communicate in English, Spanish, Mandarin Chinese or Cantonese. Exclusion Criteria: * Need for hospitalization. * Severe or Critical COVID-19: * Severe COVID-19 * Symptoms suggestive of severe systemic illness with COVID-19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress * Clinical signs indicative of severe systemic illness with COVID-19, respiratory rate ≥ 30 breaths per minute, heart rate ≥ 125 beats per minute, SpO2 ≤ 93% on room air at sea level or respiratory PaO2/FiO2 \< 300 * Critical COVID-19 -- Evidence of critical illness, defined by at least one of the following: * Respiratory failure defined based on resource utilization requiring at least one of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates \> 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) * Shock (defined by systolic blood pressure \< 90 mm Hg, or diastolic blood pressure \< 60 mm Hg or requiring vasopressors) * Multi-organ dysfunction/failure * Positive SARS-CoV-2 molecular test in the absence of Covid-19 symptoms. However if patients develop symptoms within 14 days of the positive test and fulfill all other enrollment criteria, they are eligible for participation. * Receiving the following classes of agents found in 5.4.1. Prohibited Medications * Use of drugs for anti-SARS-CoV-2 treatment including remdesivir, baricitinib, lopinavir/ritonavir fixed dose combination, ribavirin, chloroquine, hydroxychloroquine, and azithromycin, dexamethasone, bamlanivimab, casirivimab plus imdevimab convalescent plasma, or participation in a clinical trial involving any of these drugs whether for treatment or prophylaxis. * Participating in a study where co-enrollment is not allowed. * Receipt of a SARS-CoV-2 vaccination prior to study entry. * Known allergy/sensitivity or any hypersensitivity to components of XFBD * Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements. * Has known prior kidney disease. * Has known cirrhosis, acute liver disease or uncontrolled chronic liver disease. * Has known severe coronary artery disease. * Has known narrow angle glaucoma. * Has greater than two or a single uncontrolled underlying comorbid condition including cardiovascular disease (coronary artery disease, heart failure, valvular heart disease), hypertension, diabetes, chronic lung disease, chronic kidney disease, chronic liver disease, immunocompromised (HIV or daily users of more than 5 mg/day of prednisone), prior organ transplant. * Fulfills the FDA EUA criteria of at high risk for progressing to severe COVID-19. This includes high-risk individuals specified in the EUA who meet at least one of the following criteria: Body mass index (BMI) ≥35; Chronic kidney disease; Diabetes mellitus; Immunocompromising condition/immunosuppressive disease; Currently receiving immunosuppressive treatment; Aged ≥65 years; or Aged ≥55 years and have: Cardiovascular disease, or Hypertension, or Chronic obstructive pulmonary disease/other chronic respiratory disease. If the patient is not able to receive the EUA agent casirivimab and imdevimab (Regeneron) or bamlanivimab (Eli Lilly) because of unavailability this exclusion may be waived. * Women who are currently pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • University of Southern California

    Los Angeles, California, 90033, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.