| CTRI Number |
CTRI/2021/03/031664 [Registered on: 02/03/2021] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Open Label Study to Evaluate the Safety and Efficacy of SwasVimochan, SwasanRakshak, Swasamrit, Immune Energy Tablets with Mild to Moderate COVID-19 Patients |
|
Scientific Title of Study
|
A randomized, Open Label, Standard controlled,2-Arm,prospective study to investigate the safety and efficacy of the SwasVimochan,SwasanRakshak,Swasamrit,Immune Energy Tablets in Mild to Moderate COVID-19 patients. |
| 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 Rohit Parate |
| Designation |
Consultant - Medicine |
| Affiliation |
Chirayu Medical College and Hospital |
| Address |
Chirayu Medical College & Hospital
Department of Medicine, Ground Floor, Room no. 43, Bhopal-Indore Highway, Near Bairagarh
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9630033342 |
| Fax |
0755-2709132 |
| Email |
rohitparate963@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rohit Parate |
| Designation |
Consultant - Medicine |
| Affiliation |
Chirayu Medical College and Hospital |
| Address |
Chirayu Medical college & Hospital
Department of Medicine, Ground floor, Room no. 43, Bhopal-Indore Highway, Near Bairagarh
Bhopal
MADHYA PRADESH
462030
India |
| Phone |
9630033342 |
| Fax |
0755-2709132 |
| Email |
rohitparate963@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mukul Maurya |
| Designation |
Director - ProClin Research Private Limited |
| Affiliation |
ProClin Research Private Limited |
| Address |
ProClin Research Private Limited.
Second Floor,IT Tower Plot No 29,Sector 142 Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
07032802286 |
| Fax |
|
| Email |
mukul@proclinresearch.com |
|
|
Source of Monetary or Material Support
|
| Someshwar Cosmic Energy Research Center. |
|
|
Primary Sponsor
|
| Name |
Someshwar Cosmic Energy Research Center |
| Address |
Khasra No 3656/6/1, BSNL Colony, Ward No.17, Near Bachha Jail, Chhatarpur (MP) 471001. |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohit Parate |
Chirayu Medical College & Hospital |
Department of Medicine, Ground floor, Room no. 43, Bhopal-Indore Highway, Near Bairagarh, Bhopal (M.P.) 462030
Bhopal
MADHYA PRADESH |
9630033342
0755-2709132
rohitparate963@gmail.com |
| Dr Micky Shailesh Bhai Patel |
Lotus Multispeciality Hospital |
Department of Medicine,3rd Floor, Room no.40 Lotus Multispeciality Hospital Block N, Motera sabarmati, Ahmadabad-380005, Gujarat, India
Ahmadabad
GUJARAT |
9909007305
Lotushospital.79@gmail.com |
| Dr Mahesh Ramesh More |
Rajiv Gandhi Medical College & CSMH |
Department of Medicine, Second Floor, Room no.21, Thane-Belapur Rd,Kalwa,Thane 400605
Thane
MAHARASHTRA |
9960384166
maheshmore007@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional Clinical Ethics Committee |
Submittted/Under Review |
| Lotus Ethics Committee |
Submittted/Under Review |
| Vision Independent 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. Ayurveda Condition: COVID-19, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard of care |
Standard of care as per institutional practice |
| Intervention |
SwasVimochan,SwasanRakshak,Swasamrite,ImmuneEnergyTablets |
SwasVimochan(BD),SwasanRakshak(BD),Swasamrite(BD),ImmuneEnergy(TID) for 07 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Subject will be included in the study if they meet all of the following criteria:
1. Provides written informed consent.
2. Male or non-pregnant, non-lactating female aged > 18 and < 75 years (both inclusive)
3. RT-PCR confirmed diagnosis of COVID-19.
4. Finger Oxygen saturation 88 to 92% in rest state.
5.Able to take the drug orally and comply with study procedures.
6. Women of childbearing potential must have a negative urine pregnancy test prior to study entry. |
|
| ExclusionCriteria |
| Details |
Patient with severe to critical type of health condition as stratified below:
Clinical stratification:
Severe type : meeting any of the following criteria:
Respiratory distress, RR>30 times/min;
Critical type:meeting any of the following criteria:
a) Respiratory failure occurs and mechanical ventilator is required.
b) Patients go into shock.
c) ICU is needed for other organ failure.
Other viral pneumonia.
1.Patients on anticoagulant (such as aspirin, Wasfarin , heparine etc.) ( Note : patient who need anticoagulant added to their SOC regimen as per the discreation of the treating physician will be withdrawn from the study)
2.Patient who have recived tumor immunotherapy ( such as PD-1/L1,CTLA4, etc.) in the past 1 month, and inflammation factor modulator such as Ulinastatin.
3.patient who have received organ transplantation or surgery planning in the past 6 month.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Proportion of patients showing clinical improvement.
2)Improvement in Weakness.
3)Improvement in SpO2 Levels.
4)Time to first negative SARS-CoV-2 RT-PCR.
5)Duration of hospitalization.
6) Duration of supplemental oxygen therapy.
7) Time to Normalization of Symptoms. |
1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21.
2)Improvement in Weakness.Up to 3 Weeks (21 Days).
3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days).
4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days.
5)Duration of hospitalization. Upto 3 Weeks.
6) Duration of supplemental oxygen therapy, Upto 3 Weeks.
7) Time to Normalization of Symptoms, Upto 3 Weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of SwasVimotion,SwasRaksha,Swasamrit,ImmuneEnergy tablet in comparison to the standard of care for the treatment of mild to mild to moderate COVID-19 disease. |
1.Time(Days) to clinical improvement {Time Frame:upto 21 days}.
2. Clinical improvement defined as patient meeting discharge criteria OR a 2 point improvement (from time of enrolment in disease severity rating on the 7-point ordinal scale. The ordinal scale. The ordinal scale is an assessment of the clinical status at the first assessment of a given study day |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/03/2021 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
The Publication will be done after study completion |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The outbreak of coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2 in December 2019 has raised global health concerns. Coronaviruses (CoVs) are enveloped RNA Viruses related to the family Coronaviridae, the order Nirdovales, that infect humans and other mammals. The disease is characterized by fever, cough, headache and other constitutional symptoms. There has been morbidity and mortality with COVID-19.
A Proof of Concept study using SwasVimochan + SwasanRakshak + Swasamrit + Immune Energy Tablets as therapy in confirmed mild to moderate COVID-19 patients. |