The effect of cupping (Persian Method) on clinical manifestations of patients with COVID-19
Design
Clinical trial with control group, with parallel groups, not blind, randomized, phase 2 on 68 patients. 68 packets containing codes 0001 to 0068 were used for randomization. Then, by selecting one and having the selected code and using the output table of Block randomization statistical software, it is determined which group the patient is in the intervention or control group.
Settings and conduct
Patients referring to "Imam Khomeini" Hospital in Sari, "Pakdasht Martyrs" Hospital in Tehran and "Ayatollah Khansari" Hospital in Arak will enter the study at the discretion of Corona. Then, 68 patients between the ages of 18 and 75 with a probable diagnosis of COVID-19 based on national protocol, after applying the inclusion and exclusion criteria of the study and completing the conscious consent form with random blockade are placed in one of the intervention and control groups.
Participants/Inclusion and exclusion criteria
inclusion criteria: Patients between 18 and 75 years of age with a probable diagnosis of COVID-19 based on the protocol of Iran
exclusion criteria: comorbidity, pregnancy and lactation, history of allergies and any skin lesions in the area.
Intervention groups
Intervention group: The standard treatment for COVID-19 + hot cupping is 4 cm (T4) on each side of the vertebrae, 4 cm from the spinus process (for 5 minutes with a medium glass with a mouth diameter of 7 cm and a height of 7-9 cm). So that the suction rate is between 10 and 15 mm.); Three times a day for 7 days.
control group: Standard treatment of COVID-19 according to the protocol of the Ministry of Health of Iran
Main outcome variables
Blood oxygen saturation, shortness of breath, length of hospital stay
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131129015584N3
Registration date:2020-05-20, 1399/02/31
Registration timing:registered_while_recruiting
Last update:2020-05-20, 1399/02/31
Update count:0
Registration date
2020-05-20, 1399/02/31
Registrant information
Name
Assie Jokar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3324 3117
Email address
arezoo2003dr@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-04, 1399/02/15
Expected recruitment end date
2020-06-19, 1399/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cupping (Persian Method) on clinical manifestations of patients with COVID-19
Public title
The effect of hot cupping on corona symptoms
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Probable diagnosis of COVID-19 based on national Iranian protocol
Exclusion criteria:
Existence of comorbidity
Pregnancy and lactation
history of Allergy
There is any skin lesion in the area
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Before intervention, each patient selects one of the 68 envelopes that contain the codes 001 to 068, then by having the selected code and using the output table of Block randomization statistical software, it is determined the patient in which group: intervention or controls.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moallem squre, Sari, Iran.
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2020-05-04, 1399/02/15
Ethics committee reference number
IR.MAZUMS.REC.1399.162
Health conditions studied
1
Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19
Primary outcomes
1
Description
Blood oxygen saturation level
Timepoint
0,1,2,3,5,7 days after intervention
Method of measurement
Pulse oximetry
Secondary outcomes
1
Description
degree of dyspnea
Timepoint
0,1,2,3,5,7 days after intervention
Method of measurement
Likert,s scale
2
Description
Duration of hospital stay
Timepoint
7days after intervention
Method of measurement
day
Intervention groups
1
Description
Intervention group: The standard treatment for COVID-19 (Azithromycin daily + Kaletra *2 BD) + hot cupping is 4 cm (T4) on each side of the vertebrae, 4 cm from the spinus process (for 5 minutes with a medium glass with a mouth diameter of 7 cm and a height of 7-9 cm). So that the suction rate is between 10 and 15 mm.); Three times a day for 7 days.
Category
Treatment - Other
2
Description
Control group: Control group: Corona standard treatment based on the protocol of the Ministry of Health of Iran (Azithromycin daily + Kaletra *2 BD).