| CTRI Number |
CTRI/2020/08/027085 [Registered on: 11/08/2020] Trial Registered Prospectively |
| Last Modified On: |
14/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [inhalation of bioflavonoid complex] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Safety and efficacy of citrobioShield product in improving immunity in COVID 19 patients via inhalation. |
|
Scientific Title of Study
|
A single centric, prospective, open label, interventional study to evaluate the efficacy and safety of CitriobioShield as an adjunct with standard of care therapy in improving immunity in mild to moderate COVID 19 patients through inhalation of fog. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Himanshu Pophale |
| Designation |
Consultant Pulmonologist |
| Affiliation |
Mourya Multisoeciality Hospital |
| Address |
Department of pulmonology,
COVID ward, Anudatta Commercial Complex, Sinhgad Rd, Wadgaon Budruk, Narhe, Pune, Maharashtra 411041
Pune
MAHARASHTRA
Pune
MAHARASHTRA
411041
India |
| Phone |
7588693308 |
| Fax |
|
| Email |
himanshupophale@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Nagaraja Naidu |
| Designation |
CEO |
| Affiliation |
GERMKILL INDIA |
| Address |
No.50, Terrace Floor,
11th Cross,
Gangamma Temple Road,
Ashoknagar, BSK 1st Stage,
Bengaluru
Bangalore
KARNATAKA
560 050
India |
| Phone |
9449242921 |
| Fax |
|
| Email |
germkillindia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subham Dutta |
| Designation |
Director |
| Affiliation |
Syncorp Health |
| Address |
2nd Main Road, Building #06, 3rd Floor.
Arekere, Sarvobhogam Nagar.
Bangalore
Bangalore
KARNATAKA
560076
India |
| Phone |
918049788118 |
| Fax |
|
| Email |
subham@syncorp.in |
|
|
Source of Monetary or Material Support
|
| GERMKILL INDIA.
No.50, Terrace Floor,
11th Cross,
Gangamma Temple Road,
Ashoknagar, BSK 1st Stage,
Bengaluru- 560 050.
Karnataka State, INDIA. |
|
|
Primary Sponsor
|
| Name |
GERMKILL INDIA |
| Address |
No.50, Terrace Floor,
11th Cross,
Gangamma Temple Road,
Ashoknagar, BSK 1st Stage,
Bengaluru- 560 050.
Karnataka State, INDIA.
|
| Type of Sponsor |
Other [Manufacturer of organic antimicrobials, disinfectants and hand sanitizers] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Himanshu Pophale |
Mourya Multisoeciality Hospital |
COVID ward,
Anudatta Commercial Complex, Sinhgad Rd, Wadgaon Budruk, Narhe, Pune, Maharashtra 411041
Pune
MAHARASHTRA |
7588693308
himanshupophale@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee sai sneh hospital and diagnostic centre |
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 |
| Intervention |
CitrobioSheild |
organic citrus extract (Bioflavonoid Complex).
Dosage regimen: Inhalation by fogging for 3 mins per day for 7 days with 10% solution and a rate of 50 ml/min. |
| Comparator Agent |
Standard of care treatment |
Standard of care treatment as per the government approved guidelines for COVID- 19 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or non-pregnant female between 18 to 65 years of age at the time of enrolment.
2. Subject or LAR providing written informed consent and agrees to follow study procedure.
3. Woman with child bearing potential confirming use of primary contraception
4. Mild to moderate freshly confirmed COVID 19 positive subjects in less than 24 hours not requiring emergency or ICU care at the time of enrolment
|
|
| ExclusionCriteria |
| Details |
1. Severe COVID 19 patients requiring ventilation or oxygen support when diagnosed.
2. Females who are planning to conceive during the study duration or are pregnant already or are breastfeeding.
3. Subjects having serious or unstable respiratory disorders (self-reported)
4. Subject already on immune therapy (self-reported)
5. Immunodeficiency or organ transplant (self-reported)
6. Autoimmune disease (self-reported)
7. Current acute infection or exacerbation of a chronic illness (self-reported)
8. Cancer within last 5 years (self-reported)
9. Known infection with HIV, Hepatitis B & Hepatitis C (self-reported)
10. Drug abuse/alcohol abuse (self-reported)
11. Plasma donation within last 4 months (self-reported)
12. Receiving blood or immunoglobulins within 3 months (self-reported)
13. SGOT/SGPT greater than 5 times normal value (self-reported)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The time taken to relieve the individual symptoms in both the groups.
(fever, dry cough, tiredness, aches and pains, sore throat, diarrhoea, headache, loss of taste or smell, difficulty breathing or shortness of breath, chest pain or pressure) after 7 days.
2. Change in everyday clinical status of the subjects on a 7-point ordinal scale during the course of 7 days
|
7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Clinically significant change in the following safety parameters from baseline to EOT:
a. SGOT
b. SGPT
c. CBC
d. Serum Creatinine
e. Vitals
f. Occurrence of any AE/ SAE during the treatment duration.
Additional analysis Endpoint:
Clinically significant Quantitative Reduction of Viral load from baseline to EOT on exposed surface (hand surface, masks, bed sheets, PPE kits, etc).
|
7 days |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/08/2020 |
| Date of Study Completion (India) |
10/09/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="14" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is on a clinically proven
Natural & Organic, multi-purpose antimicrobial solution ‘CITROBIOSHIELD’.
The active ingredient in the product is the organic citrus extract
(Bioflavonoid Complex). CITROBIOSHIELD consists of common citrus polyphenols Evidence suggests that these substances
also have antiviral effect (Song et al., 1996).
The antimicrobial efficacy of CITROBIOSHIELD has
already been proven in various previous studies. CITROBIOSHIELD is being used
in various hospitals as air and surface disinfectant including ICUs by means of
fogging, moping and spraying. Fogging activity can be done in wards and ICUs
without shifting the patients to different place.
This study aims at evaluating efficacy
and safety of CitriobioShield as an adjunct with standard of care therapy in
improving immunity in mild to moderate COVID 19 patients by means of inhalation
fog.
The standard of care treatment will be
as per the last updated guidelines issued by the government of India. |