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Trial - ACTRN12621001372875


Column Value
Trial registration number ACTRN12621001372875
Full text link
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Abdus Shakoor

Contact
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

shakoorma@bsmmu.edu.bd

Registration date
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-10-11

Recruitment status
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

• Nasopharyngeal swab samples (tested by RT-PCR) positive for the COVID-19. • Subjects Aged 15 years or more of all genders. • O2 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 realize the content of questionnaires and who will provide consent.

Exclusion criteria
Last imported at : Oct. 13, 2021, 11:30 a.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. .• Chronic liver and kidney disease • Pregnant or lactating women • Patients admitted in ICU

Number of arms
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Bangabandhu Sheikh Mujib Medical University (BSMMU)

Inclusion age min
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

15

Inclusion age max
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

70

Countries
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Bangladesh

Type of patients
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

100

primary outcome
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Difficulty in breathing will be assessed by using Modified Medical Research Council (MMRC) scale.[At the first attendance (week one) with week 2; 3 and 4 ( primary time point) post-enrolment. ]

Notes
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : Oct. 13, 2021, 11:30 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 230, "treatment_name": "Breathing exercise", "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"}]