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)
|
http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51219
|
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"}]
|