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COVID-19 Cure Using Integrative Treatment
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注册号：

Registration number：

 ChiCTR2000040632 

最近更新日期：

Date of Last Refreshed on：

 2020-12-04 20:53:53 

注册时间：

Date of Registration：

 2020-12-04 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

COVID-19 Cure Using Integrative Treatment

Public title：

COVID-19 Cure Using Integrative Treatment

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The Effectiveness of Integrative Treatment Interventions on Covid-19 Patients: A Clinical Trial Based Evaluation

Scientific title：

The Effectiveness of Integrative Treatment Interventions on Covid-19 Patients: A Clinical Trial Based Evaluation

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：

Umber Nawaz 

研究负责人：

Muhammad Yahya Qureshi 

Applicant：

Umber Nawaz 

Study leader：

Muhammad Yahya Qureshi 

申请注册联系人电话：

Applicant telephone：

 +92 33 34888279

研究负责人电话：

Study leader's
telephone：

+92 33 49646099

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：

 umber@kric.edu.pk

研究负责人电子邮件：

Study leader's E-mail：

 yahya@kric.edu.pk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 www.kric.edu.pk

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 www.kric.edu.pk

申请注册联系人通讯地址：

9 Noon Avenue, Muslim Town, Canal Road, Lahore, Punjab, Pakistan

研究负责人通讯地址：

9 Noon Avenue, Muslim Town, Canal Road, Lahore, Punjab, Pakistan

Applicant address：

9 Noon Avenue, Muslim Town, Canal Road, Lahore, Punjab, Pakistan

Study leader's address：

9 Noon Avenue, Muslim Town, Canal Road, Lahore, Punjab, Pakistan

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：

巴基斯坦知识研究与创新中心

Applicant's institution：

Knowledge Research and Innovation Center, Pakistan (KRIC)

研究负责人所在单位：

巴基斯坦知识研究与创新中心

Affiliation of the Leader：

Knowledge Research and Innovation Center, Pakistan (KRIC)

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 KRIC/REC/1/01

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Research and Ethic Committee

Name of the ethic committee：

Research and Ethic Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-03-16 00:00:00

伦理委员会联系人：

Dr. Syed Abir Hassan Naqvi

Contact Name of the ethic committee：

Dr. Syed Abir Hassan Naqvi

伦理委员会联系地址：

IER, The University of The Punjab, New Campus, Lahore, Punjab, Pakistan

Contact Address of the ethic committee：

IER, The University of The Punjab, New Campus, Lahore, Punjab, Pakistan

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +923218437373

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 abirhassan.ier@pu.edu.pk

研究实施负责（组长）单位：

Knowledge Research and Innovation Center, Pakistan (KRIC)

Primary sponsor：

Knowledge Research and Innovation Center, Pakistan (KRIC)

研究实施负责（组长）单位地址：

9 Noon Avenue, Muslim Town, Canal Road, Lahore, Punjab, Pakistan

Primary sponsor's address：

9 Noon Avenue, Muslim Town, Canal Road, Lahore, Punjab, Pakistan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

巴基斯坦

省(直辖市)：

旁遮普

市(区县)：

拉合尔

Country：

Pakistan

Province：

Punjab

City：

Lahore

单位(医院)：

巴基斯坦知识研究与创新中心

具体地址：

9 Noon Avenue, Muslim Town, Canal Road, Lahore, Punjab, Pakistan

Institution
hospital：

Knowledge Research and Innovation Center, Pakistan (KRIC)

Address：

9 Noon Avenue, Muslim Town, Canal Road, Lahore, Punjab, Pakistan

经费或物资来源：

Knowledge Research and Innovation Center, Pakistan (KRIC)

Source(s) of funding：

Knowledge Research and Innovation Center, Pakistan (KRIC)

研究疾病：

新型冠状病毒肺炎(COVID-19)  

Target disease：

Novel Coronavirus Pneumonia (COVID-19)

研究疾病代码：

COVID-19

Target disease code：

COVID-19

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

单病例随机对照研究 

Study design：

N of 1 Trial 

研究目的：

To find the effectiveness of integrative treatment of COVID-19 patients.  

Objectives of Study：

To find the effectiveness of integrative treatment of COVID-19 patients.

药物成份或治疗方案详述：

Integrative Treatment Plan has been formulated. It simultaneously addresses five facets. First is Faith & Motivation, which informally counsels the patient to relieve fear and invoke hope for cure. Secondly, Diagnose formulates diagnostic protocol in-line with conventional medical healthcare. Thirdly, Treat furnishes Treatment Protocol using herbal medicines. Fourthly, Enhance Immunity uses appropriate diet management and natural supplements with essential nutrition. Fifthly, Prevention educates the patient, attendant and others to take necessary preventive measures for own as well as others safety as per guidelines of Center of Disease Control (CDC) Baseline outcome measure Fever, Cough, Shortness of breath, Sore Throat, Muscle Pain and RT-PCR / 10 Second Breath hold test/ Chest X-ray were measured/ conducted. All patients were intrinsically motivated in an informal manner to abolish fear and induce hope of recovery, followed by pre-treatment instructions specific to the trial: a. Patients as well as attendant were channeled towards optimum physical isolation and measures for safety of the complete family. b. Patients were instructed for strict adherence to the treatment plan as directed by the consultant. c. Patients were asked to refrain from using any other kind of treatment during the course of the study. d. Patients were asked to report their symptoms change/ follow-up on odd days through telephone/ social media. e. Patients were asked to refrain from self over/ under dosing of medicine. Experimental group was given 1gm of PAK-20 (containing Cloves, Black pepper, Cumin Seed, Cinnamon, Black cardamom, Mace Spice, Nutmeg, Star anise and Bay leaves) in 250ml of Combo 1 (soup/meat stock) twice a day for a maximum of 12 days, 50 ml of Oniater (onion water)once a day for consecutive 3 days and 250ml of Combo 2 (herbal tea) containing cloves, black pepper, green cardamom, black cardamom, stick of cinnamon, ginger slice, fennel seeds and half lemon juice twice a day for a maximum of 12 days. Datseed containing date filled with black seeds (kalonji)35 was given once a day for a maximum of 12 days. Ajwa dates seed powder (market available herbal compound) was given to specifically those patients who were already suffering from diabetes, cardiovascular disease or hyperlipidemia. Use of fruits; like Apples, Mangoes, pure organic juices; like carrot juice, orange juice, apple juice, mango milk shake even beyond 12 days until strength was restored. Meat/ lentils use for intake of proteins till recovery. Use of 70gm of Talbina once per day that increases 94 kcal, served as powerful energy diet. 

Description for medicine or protocol of treatment in detail：

Integrative Treatment Plan has been formulated. It simultaneously addresses five facets. First is Faith & Motivation, which informally counsels the patient to relieve fear and invoke hope for cure. Secondly, Diagnose formulates diagnostic protocol in-line with conventional medical healthcare. Thirdly, Treat furnishes Treatment Protocol using herbal medicines. Fourthly, Enhance Immunity uses appropriate diet management and natural supplements with essential nutrition. Fifthly, Prevention educates the patient, attendant and others to take necessary preventive measures for own as well as others safety as per guidelines of Center of Disease Control (CDC) Baseline outcome measure Fever, Cough, Shortness of breath, Sore Throat, Muscle Pain and RT-PCR / 10 Second Breath hold test/ Chest X-ray were measured/ conducted. All patients were intrinsically motivated in an informal manner to abolish fear and induce hope of recovery, followed by pre-treatment instructions specific to the trial: a. Patients as well as attendant were channeled towards optimum physical isolation and measures for safety of the complete family. b. Patients were instructed for strict adherence to the treatment plan as directed by the consultant. c. Patients were asked to refrain from using any other kind of treatment during the course of the study. d. Patients were asked to report their symptoms change/ follow-up on odd days through telephone/ social media. e. Patients were asked to refrain from self over/ under dosing of medicine. Experimental group was given 1gm of PAK-20 (containing Cloves, Black pepper, Cumin Seed, Cinnamon, Black cardamom, Mace Spice, Nutmeg, Star anise and Bay leaves) in 250ml of Combo 1 (soup/meat stock) twice a day for a maximum of 12 days, 50 ml of Oniater (onion water)once a day for consecutive 3 days and 250ml of Combo 2 (herbal tea) containing cloves, black pepper, green cardamom, black cardamom, stick of cinnamon, ginger slice, fennel seeds and half lemon juice twice a day for a maximum of 12 days. Datseed containing date filled with black seeds (kalonji)35 was given once a day for a maximum of 12 days. Ajwa dates seed powder (market available herbal compound) was given to specifically those patients who were already suffering from diabetes, cardiovascular disease or hyperlipidemia. Use of fruits; like Apples, Mangoes, pure organic juices; like carrot juice, orange juice, apple juice, mango milk shake even beyond 12 days until strength was restored. Meat/ lentils use for intake of proteins till recovery. Use of 70gm of Talbina once per day that increases 94 kcal, served as powerful energy diet. 

纳入标准：

Inclusion criteria

排除标准：

a. Any tumor or malignancy
b. Recent surgery
c. Patient on invasive / non-invasive ventilator (critical)
d. Taking any other medicine parallel to PAK-20 and Oniater for treatment of COVID-19.
Taking any immunosuppressant

Exclusion criteria：

a. Any tumor or malignancy
b. Recent surgery
c. Patient on invasive / non-invasive ventilator (critical)
d. Taking any other medicine parallel to PAK-20 and Oniater for treatment of COVID-19.
Taking any immunosuppressant

研究实施时间：

Study execute time：

从 From 2020-03-17 00:00:00至 To 2020-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-03-17 00:00:00 至 To 2020-08-03 00:00:00

干预措施：

Interventions：

组别：

Single

样本量：

 34

Group：

Single

Sample size：

干预措施：

integrative treatment

干预措施代码：

Intervention：

integrative treatment

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 巴基斯坦

省(直辖市)：

 旁遮普 

市(区县)：

 拉合尔 

Country：

Pakistan

Province：

Punjab

City：

Lahore

单位(医院)：

 Knowledge Research and Innovation Center, Pakistan (KRIC) 

单位级别：

  

Institution
hospital：

Knowledge Research and Innovation Center, Pakistan (KRIC)

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Fever

指标类型：

主要指标

Outcome：

Fever

Type：

Primary indicator

测量时间点：

0-1 week

测量方法：

Thermometer

Measure time point of outcome：

0-1 week

Measure method：

Thermometer

指标中文名：

Cough

指标类型：

主要指标

Outcome：

Cough

Type：

Primary indicator

测量时间点：

0-13 days

测量方法：

Cough scale

Measure time point of outcome：

0-13 days

Measure method：

Cough scale

指标中文名：

Sore Throat

指标类型：

主要指标

Outcome：

Sore Throat

Type：

Primary indicator

测量时间点：

0-13 days

测量方法：

Sore Throat Scale

Measure time point of outcome：

0-13 days

Measure method：

Sore Throat Scale

指标中文名：

Muscle Pain

指标类型：

主要指标

Outcome：

Muscle Pain

Type：

Primary indicator

测量时间点：

0-13 days

测量方法：

Numeric pain rating scale

Measure time point of outcome：

0-13 days

Measure method：

Numeric pain rating scale

指标中文名：

COVID-19

指标类型：

主要指标

Outcome：

COVID-19

Type：

Primary indicator

测量时间点：

测量方法：

RT-PCR Test

Measure time point of outcome：

Measure method：

RT-PCR Test

指标中文名：

10 Second Breath Hold Test

指标类型：

主要指标

Outcome：

10 Second Breath Hold Test

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Chest X-ray

指标类型：

主要指标

Outcome：

Chest X-ray

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

No

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

No Randomization was done. It was a single group study

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Nil

Blinding：

Nil

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

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）：

SPSS data file

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

SPSS data file

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 Data was collected on an online questionnaire from baseline to the 13th day follow up. Initial assessment was done on the basis of symptoms and the LAB tests (PCR-RT for COVID-19, ESR, Antibodies, D-Dimer, Chest X-rays), from baseline till 13th day of follow up. and a description of study instruments (including questionnaire and laboratory tests). To promote participant retention and complete follow-up it was emphasized by the doctor by regular consultation/follow-up as well as repeated reminders of strict adherence to the treatment plan. 5 participants out of 39 were excluded from the study. Four out of five participants were excluded due to deviation from treatment protocols whereas, only one was excluded from the study due to discontinuation of the treatment. Data Management Vigilantly planed and implemented centralized data management along with rigorous data governance procedures and appropriate personnel was followed to ensure data quality, data validity, accuracy, relevance, completeness, consistency, data profiling, control, storage and security of incoming data relevant to study. The protocol ensured data management right from the data entry, through appropriate coding process, well planned data storage (including timeframe) during and after the trial. The protocol ensures completeness of the data through correct data format, patterns, consistency on each record also ensured data security measures to prevent unauthorized access to or loss of participant data by keeping all forms in locked cabinets, data soft files related to study under password system, access of study data restricted to authorized and concerned persons only. Data Analysis Paired sample t-test was done to evaluate the outcome on symptoms before and after treatment for analyzing primary outcomes and secondarily Cross–tabulation and Chi-Square test was used to find the association of co-morbidities and side effects.

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

Data Collection Data was collected on an online questionnaire from baseline to the 13th day follow up. Initial assessment was done on the basis of symptoms and the LAB tests (PCR-RT for COVID-19, ESR, Antibodies, D-Dimer, Chest X-rays), from baseline till 13th day of follow up. and a description of study instruments (including questionnaire and laboratory tests). To promote participant retention and complete follow-up it was emphasized by the doctor by regular consultation/follow-up as well as repeated reminders of strict adherence to the treatment plan. 5 participants out of 39 were excluded from the study. Four out of five participants were excluded due to deviation from treatment protocols whereas, only one was excluded from the study due to discontinuation of the treatment. Data Management Vigilantly planed and implemented centralized data management along with rigorous data governance procedures and appropriate personnel was followed to ensure data quality, data validity, accuracy, relevance, completeness, consistency, data profiling, control, storage and security of incoming data relevant to study. The protocol ensured data management right from the data entry, through appropriate coding process, well planned data storage (including timeframe) during and after the trial. The protocol ensures completeness of the data through correct data format, patterns, consistency on each record also ensured data security measures to prevent unauthorized access to or loss of participant data by keeping all forms in locked cabinets, data soft files related to study under password system, access of study data restricted to authorized and concerned persons only. Data Analysis Paired sample t-test was done to evaluate the outcome on symptoms before and after treatment for analyzing primary outcomes and secondarily Cross–tabulation and Chi-Square test was used to find the association of co-morbidities and side effects.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-12-04 20:53:53
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