1. Home
  2. Approved trials
  3. » فارسی

Investigating the effect of cupping therapy on respiratory symptoms of patients with COVID-19

Protocol summary

Study aim
Evaluation of the therapeutic effect of cupping on respiratory symptoms in patients with COVID-19
Design
Randomized non-blinded clinical trial, with a sample size of 72, Phase 3 Clinical trial
Settings and conduct
The location of the project is Isa Ibn Maryam Hospital in Isfahan and the study will be performed as an A Randomized Clinical Trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Positive Polymerase Chain Reaction (PCR test), age over 18 years, clinical criteria of hospitalization (fever above 38℃ or severe cough or shortness of breath or respiration rate more than 24 per minute or oxygen saturation lower than 93%), confirmation of diagnosis by the cooperative infectious disease specialist, patient consent to participate in the plan Exclusion criteria: current coagulation disease, obesity, deep vein thrombosis, vertebral fracture, herniated disc, need for current hospitalization in intensive care unit (ICU), pregnancy, lactation, heart failure, chronic renal failure, receiving chemotherapy, receiving corticosteroids, immune deficiency, the presence of an open wound at the site of the cupping
Intervention groups
The intervention group, in addition, to be received the prescribed medications to treat COVID-19, will be received the cupping therapy on the posterior side of the thorax for 15 to 20 minutes daily for 5 days. The control group will be received only the prescribed medications for the treatment of COVID-19 according to the protocol of the Ministry of Health.
Main outcome variables
The length of hospital stay, fever, muscular pain, dry cough, shortness of breath, erythrocyte sedimentation rate (ESR), CRP, blood cell count, Chest X-ray, Chest computerized tomography (CT) scan

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200428047229N3
Registration date: 2020-11-25, 1399/09/05
Registration timing: registered_while_recruiting

Last update: 2020-11-25, 1399/09/05
Update count: 0
Registration date
2020-11-25, 1399/09/05
Registrant information
Name
Hanieh Tahermohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2221 4811
Email address
dr.hmohammadi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-08, 1399/06/18
Expected recruitment end date
2020-12-08, 1399/09/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of cupping therapy on respiratory symptoms of patients with COVID-19
Public title
Effect of cupping on respiratory symptoms of COVID-19
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 60 years Diagnosis confirmation by the cooperative infectious disease specialist in the project Patient's consent to participate in the project With inpatient clinical criteria (fever above 38° C or severe cough or shortness of breath or respiratory rate more than 24 per minute or oxygen saturation lower than 93%) Positive PCR
Exclusion criteria:
Current incidence of coagulopathy, obesity, deep vein thrombosis, vertebral fracture or herniated disc Need for current hospitalization in ICU Pregnancy Breastfeeding Hearth failure Chronic renal failure Receive chemotherapy Receive corticosteroids Immune deficiency Open wound at the site of cupping
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
At first due to the inclusion criteria, infectious diseases specialist diagnosis, and positive PCR test, and Samples will be randomly assigned to four blocks using Random Allocation Software. Blocking and allocation sequences for concealment will be done by the non-involved researcher (Allocation Concealment). The sample allocation ratio will be Allocation 1:1 and will be divided into two groups of receiving cupping and control group (Assignment). Then based on blocks and allocation sequences cupping therapy will be given to patients. This is an open-label study and blinding will not happen.
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 Vice-Chancellor in Research Affairs - Shahid Beheshti University of Medical Scie
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2020-09-08, 1399/06/18
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.563

Health conditions studied

1

Description of health condition studied
COVID-19
ICD-10 code
U07.1
ICD-10 code description
COVID-19, virus identified

Primary outcomes

1

Description
Dyspnea
Timepoint
At the beginning of the study (before the start of the intervention) and on days 3 and 5 after the start of cupping
Method of measurement
By using a pulse oximeter and asking the patient

Secondary outcomes

1

Description
Fever
Timepoint
At the beginning of the study (before the start of the intervention) and on days 3 and 5 after the start of the medical beer
Method of measurement
Mercury thermometer (oral)

2

Description
Muscular pain
Timepoint
At the beginning of the study (before the start of the intervention) and on days 3 and 5 after the start of the cupping
Method of measurement
By asking the patient and the Visual Analog Scale (VAS) score

3

Description
Dry cough
Timepoint
At the beginning of the study (before the start of the intervention) and on days 3 and 5 after the start of the cupping
Method of measurement
By asking the patient

4

Description
ESR
Timepoint
At the beginning of the study (before the start of the intervention) and on the 5th day after the start of the cupping
Method of measurement
Sed rate device

5

Description
CRP
Timepoint
At the beginning of the study (before the start of the intervention) and on the 5th day after the start of the cupping
Method of measurement
Agglutination kit

6

Description
Cell blood count
Timepoint
At the beginning of the study (before the start of the intervention) and on the 5th day after the start of the cupping
Method of measurement
Cell Counter device

7

Description
Chest X-ray
Timepoint
At the beginning of the study (before the start of the intervention) and on the 5th day after the start of the cupping
Method of measurement
Radiology set

8

Description
Chest CT scan
Timepoint
At the beginning of the study (before the start of the intervention) and on the 5th day, if requested by the treating physician, it will be recorded.
Method of measurement
CT scan set

Intervention groups

1

Description
Intervention group: Patients in this group receive the treatment of COVID-19 according to the protocol of the Ministry of Health, in addition, they should receive cupping therapy using special disposable plastic cups for cupping therapy, for each patient, for 5 days, once a day for 15 to 20 minutes in the back of the chest (3 glasses on each side).
Category
Treatment - Devices

2

Description
Control group: Patients in this group receive medication for COVID-19 according to the Ministry of Health protocol.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Isabn-e-Maryam hospital
Full name of responsible person
Zahra Aqanouri
Street address
Isabn-e-Mryam Hospital, Shams Abadi Ave
City
Isfehan
Province
Isfehan
Postal code
8153934691
Phone
+98 13 3273 4291
Email
aqanouri@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Rasool Choopani
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8145 5618
Email
ethics@behdasht.gov.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hanieh Tahermohammadi
Position
Assistant of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Faculty of Traditional Medicine, Shams Alley, Tavanir Station, Valiasr St., Tehran Town
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
dr.hmohammadi@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mojgan Tansaz
Position
Traditional medicine specialist, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No.8 Shams Alley, opposite Street Tavanir, Vali Asr Street, Tehran
City
Tehran
Province
Tehran
Postal code
1516745811
Phone
+98 21 8877 3521
Email
Tansaz_mojgan@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Aqanouri
Position
Iranian Traditional Medicine specialist
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
Iranian Traditional Medicine health center, at the beginning of West Shariati St., Hakim Nezami St.
City
Isfahan
Province
Isfehan
Postal code
8153934691
Phone
+98 13 3273 4291
Email
aqanouri@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...