Acupuncture as an Adjunctive Therapy for Covid-19 Omicron Randomised Controlled Trial in Patients With Moderate/Severe Pneumonia

NCT05692258 | Unknown

• 1 other identifier: 2019SK4004-06
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

At present, China is facing the first wave of COVID-19 epidemic after the liberalization. The infection rate has exceeded 50% in most areas, and even exceeded 80% in some cities. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) belongs to the beta genus of coronavirus and enters cells mainly by binding angiotensin converting enzyme 2 (ACE-2) to the spike protein on the envelope. The Omicron strain is the main epidemic strain at present. The transmission ability of Omicron strain is stronger than Delta strain, but the pathogenicity is weakened. At present, the published articles on the adjuvant treatment of COVID-19 with acupuncture are mostly theoretical discussions or case reports, and randomized controlled trials on the observation of curative effect are rare. The purpose of this study is to clarify the effectiveness of the adjuvant treatment of COVID-19 with acupuncture. Providing high-level research evidence for them.

Conditions

Acupuncture; Covid-19 Omicron; Pulmonary Function

Outcome Measures

Primary Outcomes (4)

• Modified Medical Research Council Dyspnea Scale

  On a scale of 0-4, the higher the score, the more severe the symptoms

  Once a day

• Symptom Assessment Scale for novel coronavirus pneumonia

  15 items: 7 main symptoms (0-3 points), 8 secondary symptoms (0-1 points), the higher the score, the more severe the symptoms

  Evaluate once a day

• Leicester cough questionnaire

  19 items, divided into physiological, pathological and social dimensions, each item scored 1-7 points. Dimension score = Total score of item questions in each dimension ➗ Number of questions (1-7).Total score = Sum of three dimensions scores (3-21)

  During the screening period and on the 10th day of treatment

• Visual Analogue Scale/Scor

  3 items: pharyngeal pain, muscle soreness, headache. Pain is divided into 10 points, 0 points means no pain, 10 points means severe pain, the middle part of the different degrees of pain. Have the patient draw a mark on the horizontal line according to how they feel, which indicates the level of pain. The higher the score, the worse the pain.

  Evaluate once a day

Secondary Outcomes (6)

• Vital signs and oxygen saturation

  Record twice daily

• Chest CT score

  Screening period, the 10th day of treatment

• Related blood biochemical indicators

  Screening period, treatment days 3, 7, and 10.

• Negative conversion rate of nucleic acid

  Screening period, treatment days 3, 7, and 10.

• Conversion rate of severe disease

  Tenth day of treatment

Study Arms (2)

Acupuncture therapy + basic therapy

EXPERIMENTAL

Acupuncture treatment-Selected acupoints: Dazhui (GV14) , Feishu(BL13), Dingchuan(EX-B1), Tiantu(CV22), Danzhong(RN17), Quchi(LI11), Kongzui(LU6), Neiguan(PC6), Yinlingquan(SP9), Fenglong(ST40), Qihai(cv6). Once a day for 10 consecutive times. Western medicine treatment (basic treatment) : According to the Diagnosis and Treatment Plan for Novel Coronavirus Infection (Trial 10th Edition) issued by the General Office of the National Health Commission and the General Department of the National Administration of Traditional Chinese Medicine, patients are arranged to be quarantined in hospitals for treatment. Conventional Western medicine treatment includes supportive treatment, antiviral therapy, immunotherapy, anticoagulant therapy, antibiotic therapy, etc.

Other: Acupuncture

sham acupuncture + basic therapy

SHAM COMPARATOR

sham acupuncture. Acupoint selection, body position, intervention time and course of treatment are the same as those in acupuncture treatment group. After acupoint disinfection, fixed pad is pasted on the acupoint, and 1.5 blunt needle will be used to Pierce directly through the sham instrument to fix pad to the skin surface without piercing the skin, and do not require Deqi. Western medicine treatment (basic treatment) is the same as the acupuncture group.

Other: Acupuncture

Interventions

Acupuncture OTHER

Acupuncture is a kind of therapy used to treat diseases, in which a needle (usually a millimeter needle) is inserted into a patient's skin or tissue at a certain Angle to stimulate a specific part of the body (acupoint). Disposable sterile acupuncture filiform needle (0.30mm×25mm、0.30mm×40mm), Guizhou Andi Medical Equipment Co, LTD, Guizhou Food and Drug Supervision and Equipment Production Xu 20170011.

Also known as: basic therapy

Acupuncture therapy + basic therapy; sham acupuncture + basic therapy

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) in accordance with the diagnostic criteria of western medicine. (2) moderate and severe clinical types; (3) patients over 30 years old. (4) Patients voluntarily participated in the study and signed the informed consent.

You may not qualify if:

• \- (1) critical COVID-19 patients; (2) Allergic constitution, allergic to traditional Chinese medicine components; (3) pregnant or lactating women; (4) complicated with severe cognitive and mental disorders that cannot be clearly expressed; (5) those participating in other clinical trials; (6) According to the investigator's judgment, there will be patients with complicated enrollment or poor compliance, which will affect the efficacy and safety evaluation.
• (7) complicated with active pulmonary tuberculosis, malignant arrhythmia, acute myocardial infarction, acute stroke, etc.

Sponsors & Collaborators

• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine: lead

Study Sites (1)

The First Affiliated Hospital of Hunan University of Chinese Medicine

Changsha, Hunan, 410001, China

RECRUITING

Related Publications (1)

• Liu ST, Zhan C, Ma YJ, Guo CY, Chen W, Fang XM, Fang L. Effect of qigong exercise and acupressure rehabilitation program on pulmonary function and respiratory symptoms in patients hospitalized with severe COVID-19: a randomized controlled trial. Integr Med Res. 2021;10(Suppl):100796. doi: 10.1016/j.imr.2021.100796. Epub 2021 Oct 29.

  PMID: 34733607 RESULT

Related Links

• Chen Wen-tao, Fu Huai-li, ZHANG Chao-yuan, et al. Feasibility Analysis of Acupuncture and Moxibustion in the Prevention and Treatment of COVID-19 from an International Perspective. Clinical Journal of Acupuncture and Moxibustion, 2020, 36(9): 82-87.
• Gong Yabin, Shi Xin-jie, Zhang Yan, et al. Clinical application and practice ofacupuncture therapy in treatment of coronavirus disease 2019. Chinese Acupuncture and Moxibustion, 2021, 41(2): 142-144.
• Yin Xin, CAI Shubin, Chen Luming, et al. Seventeen cases with coronavirus disease 2019(COVID-19)treated with the combination of acupuncture and herbal medicine. Chinese Acupuncture and Moxibustion, 2021, 41(5): 498-500.
• Diagnosis and Treatment Protocol for Novel Coronavirus infection (Trial version 10)

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Wei Zhang, Doctor

  +86 135 4863 9198

  STUDY CHAIR

Central Study Contacts

Wei Zhang, Doctor

CONTACT

+8613548639198; 507395550@qq.com

Wenying Shi, Master

CONTACT

+8613875866937; 273727875@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: On account of the particularity of acupuncture research, it is impossible to blind acupuncture operators. Blinded evaluation will be adopted in the trial, and the third party who does not know the grouping will evaluate the efficacy. Blind statistical analysis was used in the data summary stage, and the researchers, operators and statisticians were separated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The First Affiliated Hospital of Hunan University of Chinese Medicine

Model Details: This study is a randomized controlled study. According to the design of stratified random grouping, the subjects is stratified according to the degree of disease (moderate, severe) and age stage (30-59 years, \> 60 years), and then randomly assigned to the observation group and the control group within each stratum.

Study Record Dates

• First Submitted: January 17, 2023
• First Posted: January 20, 2023
• Study Start: January 6, 2023
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)