| CTRI Number |
CTRI/2020/09/027938 [Registered on: 21/09/2020] Trial Registered Prospectively |
| Last Modified On: |
15/01/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study of Particle Life Sciences Formulation in management of COVID-19 |
|
Scientific Title of Study
|
A randomised double blind trial to evaluate the activity of formulation of Particle Life Sciences in the management of SARS-CoV-2 Infection. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| PLS-SF-09/2020, Version 1, dated 01st Sep 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sagar Mandlik |
| Designation |
Chest Physician |
| Affiliation |
Vakratund Hospital |
| Address |
Department of Medicine,
Raghukul Sankul, Behind Hotel Bandhuraj, Pathardi Phata, Nashik.
Nashik
MAHARASHTRA
422010
India |
| Phone |
9820753549 |
| Fax |
|
| Email |
sagar.vakratund@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Sagar Mandlik |
| Designation |
Chest Physician |
| Affiliation |
Vakratund Hospital |
| Address |
Department of Medicine, Raghukul Sankul, Behind Hotel Bandhuraj, Pathardi Phata, Nashik.
Nashik
MAHARASHTRA
422010
India |
| Phone |
9820753549 |
| Fax |
|
| Email |
sagar.vakratund@gmail.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Sagar Mandlik |
| Designation |
Chest Physician |
| Affiliation |
Vakratund Hospital |
| Address |
Department of Medicine, Raghukul Sankul, Behind Hotel Bandhuraj, Pathardi Phata, Nashik.
Nashik
MAHARASHTRA
422010
India |
| Phone |
9820753549 |
| Fax |
|
| Email |
sagar.vakratund@gmail.com |
|
|
Source of Monetary or Material Support
|
| Particle Life Sciences, 201/2, Old Kashmiri Building, R R Thakur Marg, Majaswadi, Jogeshwari. Mumbai 400060. |
|
|
Primary Sponsor
|
| Name |
Particle Life Sciences |
| Address |
201/2, Old Kashmiri Building, R R Thakur Marg, Majaswadi, Jogeshwari. Mumbai 400060. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Sagar Mandlik |
Vakratund Hospital |
Department of Medicine, Raghukul Sankul, Behind Hotel Bandhuraj, Pathardi Phata, Nashik.
Nashik
MAHARASHTRA |
9820753549
sagar.vakratund@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nav Sanjeevani Hospital 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 |
| Intervention |
Particle Life Sciences Formulation Capsules |
Each capsule to be consumed orally twice a day immediately after meals for 10
days |
| Comparator Agent |
Standard Treatment protocol designed by MOHFW/ICMR |
Tab. Hydroxychloroquine (400 mg) BD on 1st day followed by
200 mg BD for 4 days; Azithromycin 500 mg 1-0-0 for 3 days (if needed); and Vitamin support for 10 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Quarantine/non hospitalized or hospitalized and fulfils WHO case definition, including a positive RT-PCR confirmed COVID-19 illness.
Age more than 18 & less than 65 years of either sex.
Mild to Moderately COVID-19 disease (NEWS score less than or equal to 8).
Patients with oxygen saturation (SpO2) less than 95%.
Respiratory rate is more than 20/min.
Pulse rate more than 90/min.
Imaging evidence of lung infection in the form of Reticulonodular opacities, ground-glass opacities and consolidation. |
|
| ExclusionCriteria |
| Details |
Pregnant women.
Breastfeeding women.
Requiring ICU admission at screening.
Patients above 65 years of age and below 18 Years.
Past History of MI, Epileptic episodes.
Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which is at critical stage at screening.
Asymptomatic patients.
Patients unwilling for informed consent.
Patients with prolonged QTc interval on ECG.
In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision
of treatments.
Participant with any immunosuppressive condition or hematological disease.
Participation in any other A.S.U and H protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Severity of disease in SARS-CoV-2.
Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, bluish discoloration of lips/face.
Serum levels of CRP, D-Dimer, Ferritin, IL-6 (At baseline and end of the study as per availability).
Clinical status expressed in percentage of subjects based on Ordinal Scale for Clinical
Improvement.
Duration of symptoms in Patients of SARS-CoV-2 measured in days. |
Screening visit, Day 0, Day 4, Day 7 and Day 10 i.e. end of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in National Early Warning Score
Hematological parameters like WBC, Hb and platelet count etc.
Requirement of admission to intensive care unit Reduced hospital duration
Changes in biochemical parameters such as liver function test and renal function test
Global assessment score for overall improvement by Investigator and subject
Safety and tolerability of the intervention |
Screening visit, Day 0, Day 4, Day 7 and Day 10 i.e. end of study |
|
|
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 3 |
|
Date of First Enrollment (India)
|
25/09/2020 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication which arise directly out of this trial results |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Objective of the Study:
Primary Objective:The primary objective of the study is to evaluate the role of Particle Life Sciences Formulation in management of COVID-19.
Secondary Objective: Safety and tolerability; clinical variables.
N=100. |