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A Randomized Controlled Trial on the Effects of Acupuncture on Relieving Symptom Burden of Long COVID Patients

注册号：

Registration number：

ITMCTR2024000360

最近更新日期：

Date of Last Refreshed on：

2024-09-03

注册时间：

Date of Registration：

2024-09-03

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

Public title：

A Randomized Controlled Trial on the Effects of Acupuncture on Relieving Symptom Burden of Long COVID Patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Scientific title：

A Randomized Controlled Trial on the Effects of Acupuncture on Relieving Symptom Burden of Long COVID Patients

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

研究负责人：

Applicant：

Aimee Choa Yu Ang

Study leader：

Shengrong Liu

申请注册联系人电话：

Applicant telephone：

(+63)9178951340

研究负责人电话：

Study leader's telephone：

(+63)9175415464

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

aimeechoayu@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

shengrongliusmic@yahoo.com.ph

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

研究负责人通讯地址：

Applicant address：

17 Panay Ave. Brgy Paligsahan Quezon City

Study leader's address：

17 Panay Ave. Brgy Paligsahan Quezon City

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

Applicant's institution：

SMIC Institute of Traditional Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

ERC Code: 1426/E/2022/236

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

Name of the ethic committee：

UERM Research Institute for Health Sciences Ethics Review Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2023/1/27 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

Dr. Maria Milagros Magat

伦理委员会联系地址：

Contact Address of the ethic committee：

2F JMC Bldg. #64 Aurora Boulevard Barangay Doña Imelda Quezon City 1113

伦理委员会联系人电话：

Contact phone of the ethic committee：

(+632)87150861

伦理委员会联系人邮箱：

Contact email of the ethic committee：

ethicsreviewcommittee@uerm.edu.ph

研究实施负责（组长）单位：

Primary sponsor：

Department of Health

研究实施负责（组长）单位地址：

Primary sponsor's address：

San Lazaro Compound Tayuman Sta. Cruz Manila Philippines

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

None

Province：

None

City：

单位(医院)：

具体地址：

Institution
hospital：

None

Address：

None

经费或物资来源：

Source(s) of funding：

SMIC Institution and Department of Health

研究疾病：

研究疾病代码：

Target disease：

COVID-19

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

Objectives of Study：

The main objective of this study is to address the need for treatment options by evaluating the effect of acupuncture in managing Long COVID Syndrome specifically in the Philippine setting.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

Participants who fulfill the following criteria were included: (1) 18 years of age or older; (2) have one or more residue symptoms or Long Covid symptoms (e.g. brain fog fatigue dyspnea cough abdominal pain etc.) at least 28 days after laboratory-confirmed COVID-19 infection (COVID-19 antigen or PCR test) that were not present before having COVID-19; and (3) patients diagnosed with qi deficiency either of the lung and heart lung and spleen or lung and kidney by a Chinese Medicine Practitioner.

排除标准：

Exclusion criteria：

Participants who have one or more of the following conditions were excluded: (1) post-COVID patients manifesting with other patterns such as yin deficiency or heat; (2) having chronic underlying diseases such as severe pulmonary cardiac bleeding disorders psychiatric or infectious diseases before having or post-COVID-19 infection; and (3) pregnant or lactating women.

研究实施时间：

Study execute time：

从From 2023-01-27

至To      2024-01-15

征募观察对象时间：

Recruiting time：

从From 2023-02-11

至To      2024-11-30

干预措施：

Interventions：

组别：

样本量：

26

Group：

Lung Kidney Experimental Group

Sample size：

干预措施：

干预措施代码：

LKE

Intervention：

Active acupuncture

Intervention code：

组别：

样本量：

22

Group：

Lung Kidney Control Group

Sample size：

干预措施：

干预措施代码：

LKC

Intervention：

Control acupuncture

Intervention code：

组别：

样本量：

33

Group：

Lung Heart Experimental Group

Sample size：

干预措施：

干预措施代码：

LHE

Intervention：

Active acupuncture

Intervention code：

组别：

样本量：

31

Group：

Lung Spleen Experimental Group

Sample size：

干预措施：

干预措施代码：

LSE

Intervention：

Active acupuncture

Intervention code：

组别：

样本量：

22

Group：

Lung Spleen Control Group

Sample size：

干预措施：

干预措施代码：

LSC

Intervention：

Control acupuncture

Intervention code：

组别：

样本量：

27

Group：

Lung Heart Control Group

Sample size：

干预措施：

干预措施代码：

LHC

Intervention：

Control acupuncture

Intervention code：

样本总量 Total sample size ： 161

研究实施地点：

Countries of recruitment
and research settings：

国家：

省(直辖市)：

市(区县)：

Country：

Philippines

Province：

National Capital Region

City：

Metro Manila

单位(医院)：

单位级别：

Institution/hospital：

SMIC Institute of Traditional Chinese Medicine

Level of the institution：

Not applicable

测量指标：

Outcomes：

指标中文名：

指标类型：

主要指标

Outcome：

Symptom burden scores

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Weeks 1 3 and 5

Measure method：

Symptom Burden Scale for Long COVID

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

结束

Completed

年龄范围：

最小 18 岁
Min age years
最大 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

Randomization Procedure (please state who generates the random number sequence and by what method)：

Participants were randomly assigned to either treatment or control groups. The randomization was done by a simple lottery (or fishbowl) technique where an equal number of control and experimental subjects were included. There were 3 fish bowls or boxes representing the three syndromes of Long COVID (LH LS and LK) with 50 Es and 50 Cs in each box. After being diagnosed with one of these syndromes the subjects were coded as follows: LH for lung heart LS for lung spleen and LK for lung kidney; then C for control and E for experimental subjects. For example LHC1 for lung heart control subject 1; LHE1 for lung heart experimental subject 1; and so on.

盲法：

Blinding：

A double-blind approach was done wherein the subjects and the SBQ-LC assessor were blinded as to the treatment regimen being received. The subjects in the control group were given control acupuncture while the subjects in the experimental group underwent the acupuncture regimen for their particular qi deficiency. This was done by a certified TCM practitioner and not by any of the study investigators. The data collection using SBQ-LC was administered by a co-investigator and assisted by a trained clinic staff. The particular persons in charge underwent training in administering the SBQ-LC in the vernacular (Tagalog). These persons also did not know to which group the subject being tested belonged to maintain the essentials of blinding and were also strictly instructed not to share the results with the rest of the investigators and TCM practitioner.

是否共享原始数据：

IPD sharing：

否

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

To be determined

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

To be determined

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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