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Trial - IRCT20210406050871N1


Column Value
Trial registration number IRCT20210406050871N1
Full text link
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

First author
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Mohammad Hassan Emamiyan

Contact
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

pishgiri@yahoo.com

Registration date
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2021-04-25

Recruitment status
Last imported at : Aug. 1, 2021, 3 p.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Completed

Study design
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

RCT

Allocation
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Randomized

Design
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Parallel

Masking
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Blind label

Center
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

single-center

Study aim
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Treatment

Inclusion criteria
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Confirmation of Covid-19 diagnosis based on PCR test results or CT Scan findings (Ground Glass view) by physician Age over 18 and under 70 years Use the same treatment protocol for patients Existence of moderate pulmonary involvement (SpO2 between 90 to 93% and pulmonary involvement less than 50%) and the patient being in the second phase of Covid-19 disease according to the guideline of the Ministry of Health

Exclusion criteria
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Drug addiction Cigarette addiction Advanced metastatic cancer Congestive heart failure (grades 3 and 4) Kidney failure requires dialysis History of mechanical ventilation before intervention Existence of cardiac pacemaker Cardiac conduction disorders History of allergies and skin sensitivities in the area of ​​the electrodes The presence of a skin lesion in the area where the electrodes are placed Hospitalized patients with other clinical manifestations of Covid-19 and no pulmonary involvement Continuous use of bronchodilators Having liver failure Moderate to severe scoliosis Obesity (BMI above 35) Psychological illnesses lead to lack of patient cooperation Cerebrovascular disorders Having COPD Having uncontrolled diabetes Inability and prohibition to be in a semi-sitting position for any reason

Number of arms
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

2

Funding
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Shahroud University of Medical Sciences

Inclusion age min
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

18

Inclusion age max
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

70

Countries
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Iran

Type of patients
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Severe disease at enrollment

Severity scale
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

6: Severe disease at enrollment

Total sample size
Last imported at : July 7, 2022, 12:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

84

primary outcome
Last imported at : July 7, 2022, 12:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Percentage of arterial blood oxygen saturation need for mechanical ventilation Death and survival vital signs (RR,HR) Severity of breathing (Dyspnea)

Notes
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Phase
Last imported at : April 26, 2021, 1 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

Not reported

Arms
Last imported at : July 7, 2022, 12:30 a.m.
Source : Iranian Registry of Clinical Trials (IRCT)

[{"arm_notes": "", "treatment_id": 454, "treatment_name": "Electrical stimulation", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]