AcupunctureZCFZZLXGBDFYHZNCT05692258
Acupuncture as an Adjunctive Therapy for Covid-19 Omicron Randomised Controlled Trial in Patients With Moderate/Severe Pneumonia
A study testing Acupuncture in people with Acupuncture and Covid-19 Omicron, run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Acupuncture, Covid-19 Omicron, Pulmonary Function
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 146 participants
- Where
- 1 siteChina
- Study dates
- 6 Jan 2023to 6 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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.
- complicated with active pulmonary tuberculosis, malignant arrhythmia, acute myocardial infarction, acute stroke, etc.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, 410001
Wei Zhang, Doctor, +86 135 4863 9198 ext. 0731, 507395550@qq.com
About this study
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.
Read the 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.
- Conditions
- Acupuncture, Covid-19 Omicron, Pulmonary Function
- Being tested
- Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
Also called basic therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Medical Research Council Dyspnea Scale
On a scale of 0-4, the higher the score, the more severe the symptoms
Measured: 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
Measured: 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)
Measured: 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.
Measured: Evaluate once a day
Secondary outcomes (6)
Vital signs and oxygen saturation
Body temperature, pulse, respiration, blood pressure, oxygen saturation
Measured: Record twice daily
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.
Measured: Screening period, the 10th day of treatment
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.
Measured: Screening period, treatment days 3, 7, and 10.
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
Measured: Screening period, treatment days 3, 7, and 10.
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%)
Measured: Tenth day of treatment
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.
Measured: Screening period, treatment days 3, 7, and 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start6 Jan 2023
- Primary completion6 Apr 2023 (estimated)
- Study completion6 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZhangWei, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
- Investigators
- Wei Zhang, Doctor, Study chair, +86 135 4863 9198
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692258
- Sponsor's protocol ID
- 2019SK4004-06
- Acronym
- ZCFZZLXGBDFYHZ
- Status last verified
- Jan 2023
- First submitted
- 17 Jan 2023
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 34733607
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture as an Adjunctive Therapy for Covid-19 Omicron Randomised Controlled Trial in Patients With Moderate/Severe Pneumonia
- ClinicalTrials.gov ID
- NCT05692258
- Acronym / sponsor ID
- ZCFZZLXGBDFYHZ / 2019SK4004-06
- Conditions
- Acupuncture, Covid-19 Omicron, Pulmonary Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Hunan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 6 Apr 2023 (estimated)
- Study completion
- 6 Apr 2023 (estimated)
- First posted
- 20 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture therapy + basic therapy | Experimental | Other: AcupunctureAcupuncture 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 + basic therapy | Sham comparator | Other: Acupuncturesham 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (2 listed)
- (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.
- complicated with active pulmonary tuberculosis, malignant arrhythmia, acute myocardial infarction, acute stroke, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureAlso: basic therapyAcupuncture 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. | Other | Acupuncture therapy + basic therapy, sham acupuncture + basic therapy |
Primary outcome
Modified Medical Research Council Dyspnea Scale
Time frame: Once a day
On a scale of 0-4, the higher the score, the more severe the symptoms
Symptom Assessment Scale for novel coronavirus pneumonia
Time frame: Evaluate once a day
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
Time frame: During the screening period and on the 10th day of treatment
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
Time frame: Evaluate once a day
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.
6 secondary outcomes
Vital signs and oxygen saturation
Time frame: Record twice daily
Chest CT score
Time frame: Screening period, the 10th day of treatment
Related blood biochemical indicators
Time frame: Screening period, treatment days 3, 7, and 10.
Negative conversion rate of nucleic acid
Time frame: Screening period, treatment days 3, 7, and 10.
Conversion rate of severe disease
Time frame: Tenth day of treatment
The total score of the self-rating anxiety Scale
Time frame: Screening period, treatment days 3, 7, and 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Results publication: PubMed 34733607Liu 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.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- 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.Link provided by the sponsor.
- Diagnosis and Treatment Protocol for Novel Coronavirus infection (Trial version 10)Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Zhang, Doctor study chair
+86 135 4863 9198
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Acupuncture and Covid-19 Omicron, run by The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhang, Doctor (+8613548639198 ext. 0731, 507395550@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Medical Research Council Dyspnea Scale (time frame: Once a day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05692258, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.