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Trial - CTRI/2020/11/029230


Column Value
Trial registration number CTRI/2020/11/029230
Full text link
Last imported at : Dec. 5, 2020, 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)

DR VIJAY KUMAR

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

vijaykr@aiimspatna.org

Registration date
Last imported at : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

2020-11-19

Recruitment status
Last imported at : Dec. 5, 2020, 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 : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Blind label

Center
Last imported at : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

multi-center

Study aim
Last imported at : Dec. 5, 2020, 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)

All patients above the age of 18 years both males and females, admitted with a diagnosis of <br/ >Moderate &amp, Severe COVID -19 (on the basis of a positive RT-PCR report) at our facility during the <br/ >study period (16/08/2020-15/12/2020)

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

1. Patients with a known allergy to or adverse drug reaction with vitamin C. <br/ >2. Patients unable to provide consent or unwilling to participate in the study. <br/ >3. Patients participating in any other ongoing clinical trial will be excluded from the study. <br/ >4. Patients below the age of 18 years will be excluded from the study. <br/ >5. Pregnant or Breastfeeding Females will be excluded from the study. <br/ >6.Patients previously complicated with End-stage Lung Disease, End stage Malignancy, Glucose-6- <br/ >Phosphate dehydrogenase deficiency, Diabetes Mellitus &amp, Diabetic Ketoacidosis , Nephrolithiasis, <br/ >Chronic Kidney Disease, Cardiogenic Pulmonary Edema will be Excluded from the study.

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 : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Not reported

Inclusion age min
Last imported at : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

18

Inclusion age max
Last imported at : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

75

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 : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Moderate/severe disease at enrollment

Severity scale
Last imported at : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

4: Moderate/severe disease at enrollment

Total sample size
Last imported at : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

80

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

1. Clinical Recovery From the disease . <br/ >2. In Hospital Mortality .Timepoint: AT WEEKLY INTERVAL

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 : Dec. 5, 2020, 12:45 a.m.
Source : International Clinical Trials Registry Platform (ICTRP)

Phase 3

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

[{"arm_notes": "", "treatment_id": 1369, "treatment_name": "Vitamin c", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]