| CTRI Number |
CTRI/2020/10/028695 [Registered on: 28/10/2020] Trial Registered Prospectively |
| Last Modified On: |
04/08/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Can Vitamin C reduces COVID-19 symptoms |
|
Scientific Title of Study
|
Role of Oral Vitamin C in Reducing the Duration and Severity of symptoms in COVID-19 Positive Patients: Prospective Randomized Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR BALBIR KUMAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 19,First floor,Academic block NCI,Jhajjar
AIIMS New Delhi
South
DELHI
110030
India |
| Phone |
7087432124 |
| Fax |
|
| Email |
drbalbir10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BALBIR KUMAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 19,First floor,Academic block NCI,Jhajjar
AIIMS New Delhi
South
DELHI
110030
India |
| Phone |
7087432124 |
| Fax |
|
| Email |
drbalbir10@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR BALBIR KUMAR |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
AIIMS New Delhi |
| Address |
Room no 19,First floor,Academic block NCI,Jhajjar
AIIMS New Delhi
NCI Jhajjar,AIIMS New Delhi
South
DELHI
110030
India |
| Phone |
7087432124 |
| Fax |
|
| Email |
drbalbir10@gmail.com |
|
|
Source of Monetary or Material Support
|
| NCI Jhajjar,AIIMS New Delhi |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| no secondary source |
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Balbir Kumar |
National Cancer Institute Jhajjar |
Room no 19 first floor Academic Block NCI Jhajjar AIIMS New Delhi
Jhajjar
HARYANA |
7006582855
drbalbir10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B972||Coronavirus as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
No vitamin C has been given to control group.Only symptomatic treatment will be given |
| Intervention |
Intervention Group |
Oral tablet vitamin C tablet 500mg (B.D)twice a day along with other symptomatic treatment till the symptoms relived or maximum 14 days,which ever earlier. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18years ,
COVID-19 positive(RT-PCR)
either sex
Symptomatic patient(fever, cough and breathing difficulty) |
|
| ExclusionCriteria |
| Details |
1. History of allergy to vitamin C
2. Pregnant females or breastfeeding mothers
3. Critical ill patient who are intubation and on mechanical ventilation
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in illness can be assessed reduction in the grading (mild,moderate sever) of symptoms after l administration of vitamin C (5oomg, twice a day) in COVID19 patients.
|
maximum time is 14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. To assess the effect on duration of illness by oral administration of vitamin C (500mg, twice a day) in COVID-19 patients
|
maximum time is 14 days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/11/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective randomised controlled trial will be started after the ethical committee approval .Oral Vitamin C 500mg b.d will be given to symptomatic cove positive patients and reduction in severity and duration symptoms like fever cough and shortness of breath (dyspnea) will be observed. |