Acupuncture and Chinese Herbal Medicine for Long COVID (ACUCM-LC)

December 12, 2025 updated by: Southern California University of Health Sciences

Acupuncture for Long COVID - A Pragmatic Pilot Study

List of the Hypothesis:

Primary hypothesis: A flexible acupuncture and Chinese herbal medicine protocol will be feasible, acceptable, and useful for the treatment of long COVID.

Secondary hypothesis: Long COVID patients receiving acupuncture treatment or acupuncture treatment and Chinese herbal supplements over an 8-week period will see improvements in their symptoms, function, and quality of life measurements.

Specific Aims of This Research (Purpose of the study):

To study the feasibility, acceptability and utility of an acupuncture and Chinese herbal supplement treatment protocol for patients with long COVID and preliminarily assess the effects of treatment.

Currently Available Research on This Subject:

Studies indicate that acupuncture can effectively treat symptoms that are similar to those often seen in long COVID patients. Additionally, recent studies and clinical evidence suggest that there is substantial potential for acupuncture in the treatment of long COVID. Acupuncture may be beneficial because it can address many symptoms simultaneously with a single intervention, whereas symptom clusters can be difficult to manage with pharmaceuticals due to the need for multiple pharmaceutical agents.

Summary of the research protocol/methodology:

Five patients will receive acupuncture treatment, and five patients will receive acupuncture and Chinese herbal medicine. Each participant will receive 16 acupuncture treatments over the course of eight weeks (i.e., twice per week). Each treatment session will last for 30 minutes. Follow-up will occur at 12 weeks (i.e., four weeks after the final treatment session).

Significance of this research to the health and welfare of general public:

There is currently not a single, specific treatment for long COVID. If acupuncture treatment alone and/or acupuncture and Chinese herbal medicine combined are feasible, acceptable, and efficacious in the improvement of long COVID symptoms, it will offer patients additional treatment options, which may help some patients to avoid pharmaceutical treatment side effects or polypharmacy challenges.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: S. Prasad Vinjamury, MD (Ayurveda) DACM, MPH
  • Phone Number: ext:736 562-947-8755
  • Email: prasad@scuhs.edu

Study Contact Backup

Study Locations

  • United States
    • California
      • Whittier, California, United States, 90604
        • Recruiting
        • SCUHS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 18 years of age or older

    • We will include adults of any age in our study. Adults of all ages can experience long COVID symptoms, although it is more common in older adults

      • Confirmed and documented COVID-19 illness (confirmed by healthcare provider or test; acceptable documentation includes but is not limited to a doctor's note or a photo of test result)

    • COVID-19 illness is a necessary precursor to the development of long COVID

      • Experiencing at least one of the following common long COVID symptoms for at least 4 weeks after confirmed COVID-19 illness:

    • Fatigue or post-exertional malaise,
    • Dyspnea, cough,
    • Brain fog, sleep disturbance, depression, anxiety,
    • Arthralgia, myalgia, or
    • Constipation, diarrhea, stomach pain

  • Over 200 different long COVID symptoms have been identified. The proposed study is a small pragmatic pilot study which only plans to enroll 10 participants. It is necessary to limit inclusion to some of the most common symptoms to ensure that the findings are broadly relevant across the long COVID patient population.

    • The symptoms were not present prior to the confirmed COVID-19 illness

      o If the symptoms were present prior to the confirmed COVID-19 illness, then they are most likely attributable to a cause other than long COVID

    • Willingness to comply with the treatment schedule

      o It is important that all those who qualify for the study are willing to comply with the protocol that is being adopted. If the patient is not willing to attend acupuncture treatment sessions or comply with the supplement schedule, then they may not be enrolled in the study.

    • Ability to read and understand English o Informed consent will be in the English language. Inability to read and understand English will interfere with provision of informed consent. Moreover, compliance is a potential issue with herbal supplementation. Recruiting patients who are able to read and understand English instructions for supplement intake will help to improve compliance with the protocol.
    • Ability to provide informed consent o It is important that participants are aware that they are required to provide written informed consent before they are allowed to participate. Some individuals who are eligible might be unwilling to sign the informed consent form.

Exclusion Criteria:

  • • Under 18 years of age

    • Pulmonary fibrosis or on continuous oxygen treatment

    • Certain preexisting conditions:

      • Diagnosed with Alzheimer's or demonstrating onset of dementia
      • Uncontrolled hypertension, diabetes, or autoimmune conditions
      • Other comorbid conditions that might imitate long COVID symptoms
    • Undergoing cancer treatments
    • Use of acupuncture or Chinese medicine in the past three months
    • Involved in health-related litigation or legal claims
    • Missing either baseline visit and deemed unlikely to comply with the study protocol
    • Pregnant or breastfeeding or trying to get pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Pragmatic experimental arm
Single-arm study looking at feasibility and acceptability of acupuncture treatment for 5 patients and acupuncture and Chinese herbal medicine for 5 patients
Procedure: Acupuncture

The investigators have developed a list of core acupoints, which will be used by all clinicians for each specific TCM diagnosis pattern identified in each patient. Similarly, a list of common herbal formulas, that we will keep in stock based on the specific diagnosis patterns, has been developed. Clinicians will have the option of using additional acupoints as necessary and will be asked to record and explain any variations from the core protocol.

  1. Residual Heat: LI-11, KI-6;Bai He Gu Jin Tang
  2. Residual Phlegm: ST-40, Sp-9;Ban Xia Bai Zhu Tian Ma Tang,Er Chen Tang
  3. Deficiency of Spleen: SP-3, ST-36;Gui Pi Tang,Xiang Sha Liu Jun Zi Tang
  4. Lung Qi Deficiency with Dampness: LU-9, LU-7;Zhi Sou San,Er Chen Tang
  5. Blood Stagnation: SP-10, SP-6;Xue Fu Zhu Yu Tang,Tao Hong Si Wu Tang
  6. Deficiency of Lung: LU-9, LU-7; Bu Fei Tang
  7. Liver Qi Stagnation: LV-3, PC-6;Xiao Yao San, Chai Hu Shu Gan Tang
  8. Yin Deficiency: KI-6, SP-6;Liu Wei Di Huang Wan
  9. Deficiency of Kidney: KI-3, KI-6;

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of Implementing a Combined Acupuncture and Chinese Herbal Medicine Intervention for long COVID
Time Frame: From enrollment to the final follow-up at 12 weeks
Feasibility will be measured through a feasibility assessment questionnaire which will evaluate recruitment, retention, and adherence metrics across the 12-week intervention and the final follow-up. Feasibility indicators will be summarized as proportions and descriptive statistics to evaluate the practicality of the study procedures and protocol implementation.
From enrollment to the final follow-up at 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient-Reported Acceptability of the Study Procedures and Treatments
Time Frame: Week 12 (final follow-up).
Acceptability will be evaluated using a participant satisfaction questionnaire administered at the end of the 12-week intervention. The survey includes Likert-scale items (1 = very dissatisfied to 5 = very satisfied) assessing participants' comfort with study procedures, satisfaction with the acupuncture and herbal treatment, and willingness to recommend participation to others. Mean scores will be calculated; higher scores indicate greater acceptability and satisfaction with the study protocol and treatment experience
Week 12 (final follow-up).
Clinician-Reported Acceptability of the Study Protocol
Time Frame: Week 12 (final follow-up).
Clinician acceptability will be measured through a self-administered survey at the end of the 12-week intervention. The survey uses a 5-point Likert scale (1 = very dissatisfied to 5 = very satisfied) to assess satisfaction with the clinical feasibility, workflow, and perceived patient benefit of the combined acupuncture and herbal medicine protocol. Scores will be averaged, and higher scores indicate greater clinician-reported acceptability.
Week 12 (final follow-up).
Change in Health-Related Quality of Life Measured by PROMIS-29 v2.1
Time Frame: Baseline, Week 4, Week 8, and Week 12.
Quality of life will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS-29 v2.1) at baseline, mid-intervention, and post-intervention. The PROMIS-29 measures physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and social participation. Each domain produces a standardized T-score (mean = 50, SD = 10). Higher scores represent better functioning for positive domains and greater symptom burden for negative domains. Changes from baseline to Week 12 will reflect improvements or declines in overall quality of life.
Baseline, Week 4, Week 8, and Week 12.
Change in Symptom Burden Measured by the Symptom Burden Questionnaire for Long COVID (SBQ™-LC)
Time Frame: Baseline, Week 8, and Week 12.
Symptom burden will be assessed using the Symptom Burden Questionnaire for Long COVID (SBQ™-LC). At baseline, participants complete all domains; at Weeks 8 and 12, they complete up to four domains corresponding to their most bothersome baseline symptoms, as well as the mandatory Mental Health and Well-Being domain. Each item is rated from 0 (no symptom) to 10 (worst possible symptom). Higher scores indicate greater symptom severity. Domain and total scores will be compared across time points to evaluate changes in symptom burden.
Baseline, Week 8, and Week 12.
Change in Whole Health Person Index (WHPI)
Time Frame: Baseline, Week 8, and Week 12.
Overall well-being will be measured using the Whole Health Person Index (WHPI), a 0-100 scale that assesses physical, emotional, and social wellness. Higher scores indicate better overall health and life balance. The change in WHPI from baseline to Week 12 will be used to evaluate perceived improvements in general well-being associated with the intervention.
Baseline, Week 8, and Week 12.
Change in Laboratory Biomarkers - Complete blood count
Time Frame: Baseline and Week 8.
Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes complete blood count (CBC) with differential. Changes in this marker will indicate biological trends in inflammation.
Baseline and Week 8.
Incidence and Severity of Adverse Events Associated with Acupuncture and Herbal Medicine
Time Frame: Throughout the 12-week study period
Safety will be monitored throughout the 12-week study by documenting adverse events (AEs) and serious adverse events (SAEs) related to acupuncture or herbal supplementation. Each event will be recorded in Qualtrics using the Adverse Event Form and graded as mild, moderate, or severe per Institutional Review Board (IRB) and Common Terminology Criteria for Adverse Events (CTCAE v5.0) guidelines. Frequency and type of AEs will be summarized descriptively as counts and percentages.
Throughout the 12-week study period
Change in Laboratory Biomarkers - Comprehensive metabolic panel
Time Frame: Baseline and Week 8.
Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes complete comprehensive metabolic panel (CMP). Changes in this marker will indicate biological trends in inflammation and metabolic function.
Baseline and Week 8.
Change in Laboratory Biomarkers - C-reactive protein
Time Frame: Baseline and Week 8.
Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes C-reactive protein (CRP). Changes in this marker will indicate biological trends in inflammation.
Baseline and Week 8.
Change in Laboratory Biomarkers - Erythrocyte sedimentation rate
Time Frame: Baseline and Week 8.
Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes erythrocyte sedimentation rate (ESR). Changes in this marker will indicate biological trends in inflammation.
Baseline and Week 8.
Change in Laboratory Biomarkers - Tumor necrosis factor-alpha
Time Frame: Baseline and Week 8.
Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes tumor necrosis factor-alpha. Changes in this marker will indicate biological trends in inflammation and metabolic function.
Baseline and Week 8.
Change in Laboratory Biomarkers - thyroid panel
Time Frame: Baseline and Week 8.
Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Test includes thyroid panel. Changes in this marker will indicate biological trends in metabolic function.
Baseline and Week 8.
Change in Laboratory Biomarkers - Vitamin D levels.
Time Frame: Baseline and Week 8.
Laboratory values will be compared from baseline to Week 8 to assess physiological effects of the intervention. Tests include vitamin D levels. Changes in these markers will indicate biological trends in inflammation and metabolic function.
Baseline and Week 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Southern California University of Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 16, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VINJ011 (Other Identifier: SCUHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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