Protocol summary

Study aim
Determining the effectiveness of acupuncture grief in improving the respiratory symptoms of hospitalized patients with coronavirus
Design
A controlled randomized clinical trial, single blinded, phase 3 on 18 patients, using Random Allocation Software for randomization
Settings and conduct
Samples include patients with coronavirus who are hospitalized in Ali Asghar Hospital in Shiraz. To blind the clinical evaluator, the study groups are named A and B.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patient's corona virus is approved by PCR test The patient is hospitalized, The patient agrees to participate in the study, The respiratory rate of the patient is more than 30 times per minute, Blood oxygen level should be less than 93%, The patient have pulmonary infiltration according to chest x-ray graph, The patient does not afflict from any serious simultaneous heart, lung, brain, and endocrine disease, Exclusion criteria: The patient suffers from any serious concomitant diseases of the heart, lungs, brain, glands, Patient dissatisfaction with participation in the study, Pregnant and lactating mothers, Existence of any conditions in the patient that, according to the physician's judgment, prevent the continuation of the treatment intervention, Resistant hypoxemia, Hemodynamic instability, Hypercapnia
Intervention groups
In intervention group ghamz with needle will be performed at six points LU5, LU7 and SP6, bilaterally for 20 minutes daily for 7 days. In control group sham therapy will be performed at six points LU5, LU7 and SP6, symmetrically on both sides of the body, (points 5 and 7 of the lung path and point 6 of the spleen path) for 20 minutes daily for 7 days. patients in both groups receive conventional medical treatments.
Main outcome variables
Vital signs and respiratory symptoms of the patient

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150825023753N17
Registration date: 2020-11-01, 1399/08/11
Registration timing: retrospective

Last update: 2020-11-01, 1399/08/11
Update count: 0
Registration date
2020-11-01, 1399/08/11
Registrant information
Name
Mohammad Mahdi Parvizi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
parvizim@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-13, 1399/01/25
Expected recruitment end date
2020-06-09, 1399/03/20
Actual recruitment start date
2020-04-13, 1399/01/25
Actual recruitment end date
2020-06-09, 1399/03/20
Trial completion date
2020-07-20, 1399/04/30
Scientific title
Evaluation of the effect of ghamz with needle, based on the knowledge of Persian medicine on improvement of respiratory symptoms of COVID-19 patients admitted to hospital
Public title
Evaluation of the effect of ghamz with needle on improvement of respiratory symptoms of COVID-19 patients admitted to hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's coronavirus is approved by PCR test The patient is hospitalized. The patient agrees to participate in the study The respiratory rate of the patient is more than 30 times per minute Blood oxygen level should be less than 93% The patient have pulmonary infiltration according to chest x-ray graph The patient does not afflict from any serious simultaneous heart, lung, brain, and endocrine disease The patient's ability and personal desire to fill out a personal consent form to enter the study
Exclusion criteria:
The patient suffers from any serious concomitant diseases of the heart, lungs, brain, glands Patient dissatisfaction with participation in the study Pregnant and lactating mothers Existence of any conditions in the patient that, according to the physician's judgment, prevent the continuation of the treatment intervention Resistant hypoxemia Hemodynamic instability Hypercapnia
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 18
Actual sample size reached: 18
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation software Ink is used to create blocks. Then, patients based on their allocated numbers, From patient number 1 to the last patient, respectively, considering the designed table are placed in groups A or B .
Blinding (investigator's opinion)
Single blinded
Blinding description
The patient and the therapist are aware of the intervention, but the clinical evaluator is unaware of the intervention.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand blv., Shiraz, Fars, Iran
City
Shiraz
Province
Fars
Postal code
14336 - 71348
Approval date
2020-04-08, 1399/01/20
Ethics committee reference number
IR.SUMS.REC.1399.043

Health conditions studied

1

Description of health condition studied
Coronavirus infection
ICD-10 code
B34.2
ICD-10 code description
Coronavirus infection, unspecified

Primary outcomes

1

Description
Respiratory rate per minutes
Timepoint
Daily
Method of measurement
Using a vital signs monitoring device (heart monitoring)

2

Description
Percentage of blood oxygen saturation
Timepoint
Daily
Method of measurement
Pulse oximeter device

3

Description
Cough
Timepoint
Daily
Method of measurement
Visual Analogue Scale (VAS)

4

Description
Dyspnea
Timepoint
Daily
Method of measurement
Visual Analogue Scale (VAS)

5

Description
Body temperature (fever)
Timepoint
Daily
Method of measurement
Thermometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In intervention group ghamz with needle will be performed at six points LU5, LU7 and SP6, symmetrically on both sides of the body, (points 5 and 7 of the lung path and point 6 of the spleen path) for 20 minutes daily for 7 days. In addition, patients receive conventional medical treatments according to the instructions issued by the Ministry of Health.
Category
Treatment - Other

2

Description
Control group: In control group sham therapy will be performed at six points LU5, LU7 and SP6, symmetrically on both sides of the body, (points 5 and 7 of the lung path and point 6 of the spleen path) for 20 minutes daily for 7 days. In addition, patients receive conventional medical treatments according to the instructions issued by the Ministry of Health.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ali Asghar Hospital
Full name of responsible person
Dr. Amir Mohammad Jaladat
Street address
Meshkin Faam Street
City
Shiraz
Province
Fars
Postal code
17439-18796
Phone
+98 71 3228 8602
Email
aliasghar@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
7th floor,Vice Chancellor of Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Amir Mohammad Jaladat
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Medical School of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134845794
Phone
+98 71 3234 9983
Email
drjaladat@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Parvizi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
mmparvizi@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Mahdi Parvizi
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Zand Ave, Shahid Faghihi Hospital,
City
Shiraz
Province
Fars
Postal code
7134846114
Phone
+98 71 3212 5592
Email
mmparvizi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic data and the result of the clinical trial
When the data will become available and for how long
6 month later
To whom data/document is available
Researchers
Under which criteria data/document could be used
After publication of the extracted article of the clinical trial
From where data/document is obtainable
Sending Email to the researchers
What processes are involved for a request to access data/document
Sending the request via the email
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