search
Back to results

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

Primary Purpose

Acupuncture, Covid-19 Omicron, Pulmonary Function

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acupuncture

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: (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. Exclusion Criteria: - (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.

Sites / Locations

  • The First Affiliated Hospital of Hunan University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Acupuncture therapy + basic therapy

sham acupuncture + basic therapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Modified Medical Research Council Dyspnea Scale
On a scale of 0-4, the higher the score, the more severe the symptoms
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
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)
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.

Secondary Outcome Measures

Vital signs and oxygen saturation
Body temperature, pulse, respiration, blood pressure, oxygen saturation
Chest CT score
In 6 areas of the right lung upper field, right lung middle field, right lung lower field, left lung upper field, left lung middle field, left lung lower field, reticular change 1 point, ground glass 2 points, patchy blur 3 points, small patchy blur 4 points, cystic lung honeycomb 5 points, the total score is 30 points, the higher the score is, the more severe the lung lesions.
Related blood biochemical indicators
Routine blood test, coagulation test, D-dimer, C-reactive protein, erythrocyte sedimentation rate, procalcitonin, cytokines (interleukin-6, interleukin-1, ferritin), myocardial enzymes, T lymphocyte subsets (CD4+, CD8+), liver function, renal function laboratory indicators, and blood gas analysis were also recorded in severe patients.
Negative conversion rate of nucleic acid
The nucleic acid of 2019-ncov will be detected by fluorescence quantitative polymerase chain reaction, and the negative conversion rate of nucleic acid will be calculated
Conversion rate of severe disease
According to the clinical classification of "Diagnosis and Treatment Protocol for Novel Coronavirus Infection (Trial 10th Edition)", the number of patients who turned from medium to severe or critical will be recorded. Calculate the conversion rate of severe disease (number of severe disease cases/total cases × 100%)
The total score of the self-rating anxiety Scale
20 items, each item 1-4 points, total score and standard score (total score ×1.25), the higher the score, the more severe symptoms.

Full Information

First Posted
January 17, 2023
Last Updated
January 19, 2023
Sponsor
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT05692258
Brief Title
Acupuncture as an Adjunctive Therapy for Covid-19 Omicron Randomised Controlled Trial in Patients With Moderate/Severe Pneumonia
Acronym
ZCFZZLXGBDFYHZ
Official Title
Acupuncture as an Adjunctive Therapy for Covid-19 Omicron Randomised Controlled Trial in Patients With Moderate/Severe Pneumonia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 6, 2023 (Actual)
Primary Completion Date
April 6, 2023 (Anticipated)
Study Completion Date
April 6, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
This is a stratified randomized trial. Firstly, the subjects were stratified according to disease severity (moderate, severe) and age stage (30-59 years, > 60 years), and then the subjects were randomly assigned to the observation group and the control group within each stratum. The study center will screen cases strictly according to the diagnostic criteria, inclusion criteria and exclusion criteria. After confirmation of enrollment, random numbers will be obtained according to the application for random coding process until the total number of observation is completed. 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. In the observation group (acupuncture treatment + basic treatment), acupuncture will be applied at Dazhui (GV 14), Feishu (BL 13), Dingchuan (GV 14), Tiantu (GV 14), Danzhong (CV 17), Quchi (GV 20), Gongzhi (CV 4), Neiguan (PC 6), Yinlingquan (SP 9), Fenglong (ST 40), Qihai (CV 6). In the control group (sham acupuncture + basic treatment), sham acupuncture will be used. The acupoint selection is the same as the acupuncture treatment group, Before acupuncture, the fixed pad was pasted on the acupoints, 1.5-inch blunt needle will be used to Pierce the skin surface through the fixed pad of the sham appliance without puncturing the skin. The mMRC and COVID-19 symptom assessment scale were used as the main evaluation indicators, and the Leicester cough questionnaire LCQ was used to record cough. VAS pain score visual analogue scale was used to evaluate the daily situation of sore throat, muscle soreness, and headache. Secondary outcomes included vital signs and oxygen saturation, chest CT score, and related blood biochemical indicators, including: Blood routine, coagulation routine, D-dimer, C-reactive protein, erythrocyte sedimentation rate, procalcitonin, cytokines (interleukin-6, interleukin-1, ferritin), myocardial enzymes, T lymphocyte subsets (CD4+, CD8+), liver function, renal function, blood gas analysis (severe patients), nucleic acid negative conversion rate, severe conversion rate, self-rating anxiety scale (SAS). Uniform training was provided to all study personnel. The training focused on the use of randomization system and case entry system, project implementation and standard operating procedures, so that each researcher could be familiar with the research process and specific implementation rules, so as to improve the intra-observer consistency and inter-observer consistency of researchers and ensure the reliability of clinical research conclusions. An independent efficacy evaluator was required. Efficacy raters and statistical analysts were blinded. Statistical analyses were performed by a third party, and statistical analysts were blinded during the trial. Statistical analysis will be calculated using SPSS22.0 statistical analysis software. P<0.05 (i.e., =0.05) was considered to indicate statistical significance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Covid-19 Omicron, Pulmonary Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
146 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture therapy + basic therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
sham acupuncture + basic therapy
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Acupuncture
Other Intervention Name(s)
basic therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Modified Medical Research Council Dyspnea Scale
Description
On a scale of 0-4, the higher the score, the more severe the symptoms
Time Frame
Once a day
Title
Symptom Assessment Scale for novel coronavirus pneumonia
Description
15 items: 7 main symptoms (0-3 points), 8 secondary symptoms (0-1 points), the higher the score, the more severe the symptoms
Time Frame
Evaluate once a day
Title
Leicester cough questionnaire
Description
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)
Time Frame
During the screening period and on the 10th day of treatment
Title
Visual Analogue Scale/Scor
Description
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.
Time Frame
Evaluate once a day
Secondary Outcome Measure Information:
Title
Vital signs and oxygen saturation
Description
Body temperature, pulse, respiration, blood pressure, oxygen saturation
Time Frame
Record twice daily
Title
Chest CT score
Description
In 6 areas of the right lung upper field, right lung middle field, right lung lower field, left lung upper field, left lung middle field, left lung lower field, reticular change 1 point, ground glass 2 points, patchy blur 3 points, small patchy blur 4 points, cystic lung honeycomb 5 points, the total score is 30 points, the higher the score is, the more severe the lung lesions.
Time Frame
Screening period, the 10th day of treatment
Title
Related blood biochemical indicators
Description
Routine blood test, coagulation test, D-dimer, C-reactive protein, erythrocyte sedimentation rate, procalcitonin, cytokines (interleukin-6, interleukin-1, ferritin), myocardial enzymes, T lymphocyte subsets (CD4+, CD8+), liver function, renal function laboratory indicators, and blood gas analysis were also recorded in severe patients.
Time Frame
Screening period, treatment days 3, 7, and 10.
Title
Negative conversion rate of nucleic acid
Description
The nucleic acid of 2019-ncov will be detected by fluorescence quantitative polymerase chain reaction, and the negative conversion rate of nucleic acid will be calculated
Time Frame
Screening period, treatment days 3, 7, and 10.
Title
Conversion rate of severe disease
Description
According to the clinical classification of "Diagnosis and Treatment Protocol for Novel Coronavirus Infection (Trial 10th Edition)", the number of patients who turned from medium to severe or critical will be recorded. Calculate the conversion rate of severe disease (number of severe disease cases/total cases × 100%)
Time Frame
Tenth day of treatment
Title
The total score of the self-rating anxiety Scale
Description
20 items, each item 1-4 points, total score and standard score (total score ×1.25), the higher the score, the more severe symptoms.
Time Frame
Screening period, treatment days 3, 7, and 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (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. Exclusion Criteria: - (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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Zhang, Doctor
Phone
+8613548639198
Ext
0731
Email
507395550@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wenying Shi, Master
Phone
+8613875866937
Ext
0731
Email
273727875@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Zhang, Doctor
Organizational Affiliation
+86 135 4863 9198
Official's Role
Study Chair
Facility Information:
Facility Name
The First Affiliated Hospital of Hunan University of Chinese Medicine
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Zhang, Doctor
Phone
+86 135 4863 9198
Ext
0731
Email
507395550@qq.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Our subject database is called Zintuikang Integrated Big Data Application Platform, and other researchers can access it through the website. The administrator set up the account, and other researchers can log in by changing the password after registration. Their account has the authority to access the data and enter the CRF form.
Citations:
PubMed Identifier
34733607
Citation
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.
Results Reference
result
Links:
URL
http://kns.cnki.net.hnucm.opac.vip/KXReader/Detail?invoice=gze5UIE9Q3FuCnOu1YRN%2BiCwI2UI2UCZvAtrR0fHKxDfVyMfBw8Arl0qAA1f2cH2yhnOUracq8Ij7i5TLwzzsOikj7MqShZ2RZB6y3soW9qXFNFKHlqS88zPDo%2FhumNHMkTN35znxkjWlDt94nOZB4eAE3ZdrUqGxHOLFhYbkmg%3D&DBCODE=CJFD&FileName=ZJLC202009021&TABLEName=cjfdlast2020&nonce=2264F64B440C4602A8D2E12DB11E3E2B&uid=&TIMESTAMP=1673599446541
Description
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.
URL
http://kns.cnki.net.hnucm.opac.vip/KXReader/Detail?invoice=hJnoZj%2BwVzUzyXuOanIy0k%2Frb8wPX27e1oMnetz6JwfjapXJKdSZcx8zsW3PPc8gfQf9g5%2B7TBwG%2FJV6cUACmxsi4xTTZDDBNAMp69vwAZ69inEeh3bfpM0biWZhD23TL%2BO9nQ0hBxBaNsNUc76iM29n569ygwJJEW74r2XdfOY%3D&DBCODE=CJFD&FileName=ZGZE202102009&TABLEName=cjfdlast2021&nonce=54B21AEDF168419FB99D068D6564ADA5&uid=&TIMESTAMP=1673599706418
Description
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.
URL
http://kns.cnki.net.hnucm.opac.vip/kcms/detail/detail.aspx?dbcode=CJFD&dbname=CJFDLAST2021&filename=ZGZE202105007&uniplatform=NZKPT&v=ymNwlExQ0p8iVITbnlr7LmEbS-Z8sA-uPSCEYTABJHzI1r5snIrG3n8TflNU_-Bu
Description
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.
URL
http://www.gov.cn/zhengce/zhengceku/2023-01/06/content_5735343.htm
Description
Diagnosis and Treatment Protocol for Novel Coronavirus infection (Trial version 10)

Learn more about this trial

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

We'll reach out to this number within 24 hrs