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Trial - CTRI/2022/01/039666


Column Value
Trial registration number CTRI/2022/01/039666
Full text link
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Dhruvi Jignesh Shah

Contact
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Poonam.parulekar@nmims.edu

Registration date
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

2022-01-21

Recruitment status
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Cluster

Masking
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Open label

Center
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

COVID-19 infected Subjects. <br/ > Both male and female. <br/ > Minimal or no oxygen support <br/ >

Exclusion criteria
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Individuals requiring ICU admission. <br/ > Uncontrolled diabetes. <br/ > Chronic Cardiac disorders. <br/ > Known case of arthritis, malignancy <br/ > Recent fracture or recent surgery <br/ > Pregnancy <br/ >

Number of arms
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

None

Inclusion age min
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

70

Countries
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

India

Type of patients
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Mild disease at enrollment

Severity scale
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

1: Mild disease at enrollment

Total sample size
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

50

primary outcome
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

6- Minute walk test <br/ >Modified Borg scale <br/ >Chalder Fatigue Scale <br/ >Depression; Anxiety and Stress scale-21. <br/ >Timepoint: Pre and post assessment

Notes
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

| Declared number of arm (2.0) differs from found arms (3.0)

Phase
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 2

Arms
Last imported at : Feb. 25, 2022, noon
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 579, "treatment_name": "High-intensity aerobic", "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"}]