Medical Herbs for COVID-19

(COVID Trial)

Overseen By Wanzhu Hou, CMD, MD(CN)

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: All Natural Medicine Clinic, LLC

Disqualifiers: Prior COVID-19, Age, Severe illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how medical herbs might help manage the immune response in people with COVID-19. The goal is to determine if these herbs can prevent the immune system from overreacting, which can lead to organ damage. Participants will try different herbs to assess whether they can help the body fight the virus more effectively without causing harm. Individuals who tested positive for COVID-19 in the past 1-20 days and have symptoms like fever or cough may be suitable candidates for this trial. As a Phase 1 and Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. Participants who are already on conventional medication treatment can continue their treatment while participating in this study.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that using herbal medicines to manage COVID-19 is generally safe. A review of several studies found that many herbal treatments are well-tolerated and safe. These herbs have been used for thousands of years, supporting their reliability. Some research even suggests that herbal treatments might be safer than some standard medications.

People with COVID-19 who have used herbal medicine often report positive results, with many experiencing benefits and few major side effects. This suggests that herbal medicines are safe, especially since they help calm the immune system to prevent harmful overreactions.

Although these herbs are still in the early stages of clinical trials for COVID-19, their long history and some early research indicate they are generally safe. For those considering joining a trial, this information can help reassure about the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using medical herbs for treating COVID-19 because these treatments offer a natural alternative to standard care options like antivirals and monoclonal antibodies. Unlike typical treatments that mainly target the virus itself, these herbs focus on reducing inflammation, which is a significant cause of severe symptoms in COVID-19 patients. Each treatment arm targets different aspects of inflammation: one addresses upper and lower respiratory tract inflammation and fever, another focuses on cough and chest pain, and the third tackles metabolites and clots. This approach could provide a more comprehensive management of symptoms, potentially leading to faster recovery and fewer complications.

What evidence suggests that medical herbs might be an effective treatment for COVID-19?

Research has shown that herbal treatments can help manage COVID-19 by reducing inflammation and supporting the immune system. This trial will evaluate different herbal formulations targeting various inflammation-related symptoms. Studies have found that herbal medicines fight viruses, reduce inflammation, and balance the immune system. These effects can lessen symptoms and aid recovery in COVID-19 patients. Some evidence suggests that these herbs can also shorten hospital stays and reduce death rates. Chinese herbal formulas, in particular, have been extensively studied and show promise in clinical trials for improving COVID-19 outcomes. While study results vary, many people have turned to herbal treatments during the pandemic, believing they can boost immunity. ^{6 7 8 9 10}

Who Is on the Research Team?

Wanzhu Hou, CMD,MD(CN)

Principal Investigator

All Natural Medicine Clinic, LLC

Are You a Good Fit for This Trial?

This trial is for people aged 10-70 with recent (1-20 days) COVID-19 infection, regardless of gender, race, or nationality. They must have specific blood tests and lung images ready and can be on conventional treatments.

Inclusion Criteria

I am between 10 and 70 years old.

I am currently taking or have not taken standard medication for my condition.

The Participants must repeat the evaluation experiment during and at the end of the clinical study

Exclusion Criteria

Individuals with a prior COVID-19 virus infection that no longer shows up from COVID-19 testing

My child is under 10 and struggles with taking medicine on schedule.

Patients diagnosed with COVID-19 virus infection but do not willing to share their information with the public

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medical herbs to mediate immune response and inhibit inflammation

6 weeks

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Medical Herbs

Trial Overview The study tests if medical herbs can rebuild the immune system to fight COVID-19 without causing a harmful overreaction. It compares standard care with three different herbal inflammation treatments.

How Is the Trial Designed?

Group I: Inflammation (III) Active Control 2 Interventions

1. Metabolites 2. Clots

Group II: Inflammation (I) Active Control 2 Interventions

1. Upper respiratory inflammation. 2. Fever. 3. Lower respiration inflammation.

Group III: Inflammation (II) Active Control 2 Interventions

Cough, chest pain

Who Is Running the Clinical Trial?

All Natural Medicine Clinic, LLC

Lead Sponsor

Trials

2

Recruited

2,100+

Published Research Related to This Trial

In a study of 167 COVID-19 positive patients treated with Ayurvedic interventions, there was a quick resolution of symptoms and no deterioration in any cases, indicating effective management of the disease.

The Ayurvedic treatment was safe, with no adverse events reported, and it was particularly beneficial for patients with multiple comorbidities, suggesting its potential as a low-cost option for early intervention in COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stand-alone Ayurvedic intervention with home quarantine in COVID-19 - Outcomes of clinical practice. Girija, PLT., Sivan, N., Murugavel, YA., et al.[2022]

Only 18% of university students reported using Chinese herbs to prevent COVID-19, indicating a gap between positive attitudes and actual practices.

Despite a generally positive attitude towards Chinese herbal medicine, students demonstrated a lack of knowledge, scoring an average of only 1.64 out of 5 on related knowledge assessments, highlighting the need for better education on the pharmacological properties of these herbs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practices, Knowledge, and Attitudes of Chinese University Students Toward Traditional Chinese Herbal Medicine for the Control of COVID-19. Li, H., Liu, J., Hu, X., et al.[2022]

COVID-19 can cause gastrointestinal symptoms, indicating that the gastrointestinal tract may be a target for SARS-CoV-2, as the virus uses the ACE2 receptor, which is highly expressed in intestinal cells.

Herbal treatments may help restore the balance of intestinal flora, potentially improving immune function and aiding recovery from COVID-19, suggesting a new approach to managing the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herbal Medicine, Gut Microbiota, and COVID-19. Chen, Z., Lv, Y., Xu, H., et al.[2022]

A Persian herbal medicine formula significantly reduced the mean hospitalization days for COVID-19 patients by approximately 2.95 days compared to those receiving only routine treatment, based on a study of 79 hospitalized patients.

The herbal treatment also led to notable improvements in symptoms such as dyspnea and the need for oxygen therapy, with no reported adverse effects, suggesting it could be a safe adjuvant therapy for COVID-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Persian herbal medicine compound on coronavirus disease 2019 (COVID-19): A randomized clinical trial. Setayesh, M., Karimi, M., Zargaran, A., et al.[2022]

The use of traditional Chinese medicine (TCM) during the COVID-19 pandemic is positively correlated with higher regional cure rates in China, suggesting its potential effectiveness in treatment.

Analysis of 185 TCM recipes revealed that several commonly used herbs have direct anti-SARS-CoV-2 properties, with the top candidate, madreselvin B, showing promising binding affinity to key viral proteins, indicating a multifactorial mechanism of action that includes immunoregulation and anti-inflammatory effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herbal plants coordinate COVID-19 in multiple dimensions - An insight analysis for clinically applied remedies. Zhang, Y., Li, Y., Wang, X., et al.[2022]

In a randomized clinical trial involving 150 hospitalized COVID-19 patients, olive leaf extract significantly improved vital signs and laboratory markers compared to a placebo, indicating its potential efficacy in managing COVID-19 symptoms.

Both doses of olive leaf extract (250 mg and 500 mg every 12 hours for five days) resulted in lower body temperature, pulse rate, respiratory rate, and inflammatory markers, while improving oxygen saturation, suggesting it may enhance recovery and reduce hospitalization duration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of olive leaves extract on the outcomes of hospitalized covid-19 patients: A randomized, triple-blinded clinical trial. Ahmadpour, E., Toulabi, T., Yadegarinia, D., et al.[2023]

Phytopharmaceuticals significantly improved recovery rates in COVID-19 patients (odds ratio of 3.54) and reduced mortality (odds ratio of 0.24), indicating their potential effectiveness as a treatment option.

These herbal medicines also provided protective effects against specific COVID-19 symptoms like dyspnea and myalgia, although they did not show significant effects on cough and fever, suggesting targeted benefits in symptom management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Herbs as Complementary and Alternative Therapy in Recovery and Clinical Outcome Among People with COVID-19: A Systematic Review, Meta-Analysis, and Meta-Regression. Komariah, M., Amirah, S., Maulana, S., et al.[2023]

In a study involving 358 hospitalized patients, those who received herbal remedies alongside standard care experienced a significantly shorter duration of hospital stay due to respiratory symptoms (3.29 days vs. 6.47 days).

The herbal treatment also led to faster clinical improvement and reduced various symptoms associated with respiratory infections, suggesting that these polyherbal formulations could be a promising adjunct therapy for managing COVID-19 with good tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Persian medicine herbal formulations (capsules and decoction) compared to standard care in patients with COVID-19, a multicenter open-labeled, randomized, controlled clinical trial. Karimi, M., Zarei, A., Soleymani, S., et al.[2021]

A systematic review of 32 randomized controlled trials involving 3177 COVID-19 patients found that herbal interventions, when used alongside Western medicine, significantly improved symptoms like fever, cough, and fatigue compared to Western medicine alone.

The study indicated that herbal treatments also led to better laboratory outcomes, such as improved white blood cell counts and lymphocyte percentages, without significant adverse events reported, suggesting a safe complementary approach to COVID-19 management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of herbal medicines in the management of patients with COVID-19: A systematic review and meta-analysis of randomized controlled trials. Kumar, A., Rai, A., Khan, MS., et al.[2022]

A systematic review of 35 randomized controlled trials and 24 observational studies involving 16,580 mild to moderate COVID-19 patients found that Chinese herbal medicine (CHM) significantly reduced the rate of conversion to severe cases and mortality compared to usual supportive treatments.

CHM also helped shorten the time to symptom resolution, length of hospital stay, and time to viral clearance, while showing a safety profile comparable to standard care, with no serious adverse reactions reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of chinese herbal medicine for treating mild or moderate COVID-19: A systematic review and meta-analysis of randomized controlled trials and observational studies. Zhu, H., Li, M., Tian, C., et al.[2022]

Herbal medicine, when used alongside standard COVID-19 treatments, showed significant benefits in improving symptoms such as fever, cough, and fatigue, as well as reducing hospital stay duration and all-cause mortality, based on a meta-analysis of randomized controlled trials.

Despite these positive findings, the overall certainty of the evidence is low due to methodological limitations in the studies, and there were no significant differences in adverse events between herbal medicine and standard treatment alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herbal Medicine Intervention for the Treatment of COVID-19: A Living Systematic Review and Cumulative Meta-Analysis. Ang, L., Song, E., Hu, XY., et al.[2023]

A review of seven randomized controlled trials involving 855 patients found that combining herbal medicine with Western medicine significantly improved treatment outcomes for COVID-19, including higher rates of symptom disappearance for cough and sputum production.

No serious adverse events were reported, suggesting that the combined therapy is safe; however, the overall risk of bias in the studies was unclear, indicating a need for more high-quality research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Herbal Medicine for the Treatment of Coronavirus Disease 2019 (COVID-19): A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Ang, L., Song, E., Lee, HW., et al.[2023]

Traditional Chinese medicine (TCM) was used in 91.50% of COVID-19 cases in China, showing promising results in managing symptoms and reducing severe outcomes like mortality and recurrence rates.

A total of 166 modified herbal formulae were identified, with key herbs like Glycyrrhizae Radix et Rhizome and Scutellariae Radix being frequently used, and 12 clusters of molecules were analyzed for their potential to inhibit the coronavirus, suggesting a systematic approach to developing effective treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analysis on herbal medicines utilized for treatment of COVID-19. Luo, L., Jiang, J., Wang, C., et al.[2020]

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