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Trial - ACTRN12621001108808


Column Value
Trial registration number ACTRN12621001108808
Full text link
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Abdus Shakoor

Contact
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

shakoorma@bsmmu.edu.bd

Registration date
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-08-20

Recruitment status
Last imported at : Nov. 5, 2021, 2:05 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

• Nasopharyngeal swab samples (tested by RT-PCR) positive for the novel coronavirus. • Subjects Aged 15 years or more of all genders. • Oxygen saturation as measured by pulse oximetry (SpO2) greater than 90 % in room air. • Patients having symptoms mild to moderate in nature • A resting respiratory rate 30/m or less than 30/m. • Able to understand the content of questionnaires and who will provide informed consent.

Exclusion criteria
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

• Subjects aged more than 70 years of all genders. • Subjects having severe form of COVID-19 • Subjects having severe COPD, bronchial asthma and severe ischemic heart disease. • Pregnant woman will be excluded from the study.

Number of arms
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

BANGLADESH MEDICAL RESEARCH COUNCIL

Inclusion age min
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

15

Inclusion age max
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

70

Countries
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Bangladesh

Type of patients
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Mild/moderate disease at enrollment

Severity scale
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2: Mild/moderate disease at enrollment

Total sample size
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

155

primary outcome
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Breathing difficulty will be assessed by using Modified Medical Research Council (MMRC) scale.[ At week one with week 2; 3 and 4 (post-enrolment)];Modified Borg Scale (MBS) to determine the breathing difficulty after exercise[Weekly for four weeks post-enrolment]

Notes
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : Aug. 27, 2021, 9:45 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 1043, "treatment_name": "Pulmonary rehabilitation", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]