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Trial - CTRI/2021/02/031036


Column Value
Trial registration number CTRI/2021/02/031036
Full text link
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

First author
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

DrRuchi Dua

Contact
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

ruchi.pulm@aiimsrishikesh.edu.in

Registration date
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2021-02-05

Recruitment status
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not recruiting

Study design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

RCT

Allocation
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Randomized

Design
Last imported at : Nov. 18, 2021, 7:33 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Parallel

Masking
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Blind label

Center
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

single-center

Study aim
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Treatment

Inclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Consenting <br/ >18-70 years, either sex <br/ >Diagnosed case of Covid-19 based on RT PCR, hospitalized at AIIMS Rishikesh covid centre in moderate symptom category as per ICMR guidelines (dyspnea/hypoxia with saturation <94% on room air/Respiratory rate >24breaths/minute)8 <br/ >Having a smartphone and internet facility and able to use it <br/ >Serum procalcitonin <0.5 ng/ml

Exclusion criteria
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Non-consenting/critical category as per <br/ >ICMR guidelines1 <br/ > <br/ >Patients in ICU or on mechanical <br/ >ventilation/continuous NIV or Fio2 >.40 <br/ > <br/ >Patients unable to perform Pranakarshan <br/ >Pranayama/Gayatri Mantra <br/ > <br/ >Patients with known psychiatric or <br/ >COPD/CLD/CRF/BA/diabetics(HbA1c >7),se <br/ >vere HT, malignancy,IBD,CAD. <br/ > <br/ >Pregnant/lactating females

Number of arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2

Funding
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Department of Science Technology DST

Inclusion age min
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

70

Countries
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

India

Type of patients
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

20

primary outcome
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

hs C-Reactive protein (highly sensitive CRP)Timepoint: baseline;at time of discharge/14 days

Notes
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

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

Phase
Last imported at : Feb. 27, 2021, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Arms
Last imported at : Nov. 26, 2021, 10:30 p.m.
Source : International Clinical Trials Registry Platform (ICTRP)

[{"arm_notes": "", "treatment_id": 1109, "treatment_name": "Respiratory exercises", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "1 or 2;day0-28", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]