Trial Radar KI | ||
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Die klinische Studie NCT07285707 (ACUCM-LC) für Langzeit-COVID ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Acupuncture and Chinese Herbal Medicine for Long COVID (ACUCM-LC) 10
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.
Sp...
Mehr anzeigenAcupuncture for Long COVID - A Pragmatic Pilot Study
- ACUCM-LC
- VINJ011
- VINJ011 (Andere Kennung) (SCUHS)
acupuncture for long COVID
Chinese medicine for long COVID
Chinese herbal medicine for long COVID
acupuncture
Chinese herbal medicine
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellPragmatic 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 | Akupunktur 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 var...Mehr anzeigen |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Feasibility of Implementing a Combined Acupuncture and Chinese Herbal Medicine Intervention for long COVID | 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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Patient-Reported Acceptability of the Study Procedures and Treatments | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. |
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.
• 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
Southern California University of Health SciencesCalifornia