| CTRI Number |
CTRI/2020/10/028635 [Registered on: 26/10/2020] Trial Registered Prospectively |
| Last Modified On: |
24/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
use of VIRUNIL an Ayurvedic medicie as a supportive treatment in management of COVID-19. |
|
Scientific Title of Study
|
Clinical evaluation of Virunil a standardized ayurvedic herbal compound as an adjuvant in management of COVID-19 |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K V S Kumar Chowdary |
| Designation |
M.S (E.N.T) |
| Affiliation |
NRI Medical College & GH |
| Address |
E N T DEPARTMENT, ROOM NO-10.
NRI Medical College & GH,
CHINNA KAKANI, GUNTUR DISTRICT.
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7893451789 |
| Fax |
|
| Email |
chowdaryent@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kuricheti S S Siva Krishna |
| Designation |
M.D (Ayurveda) |
| Affiliation |
N R I MEDICAL COLLEGE AND GENERAL HOSPITAL |
| Address |
E N T DEPARTMENT, ROOM NO-10.
NRI Medical College & GH,
CHINNA KAKANI, GUNTUR DISTRICT.
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
7075096010 |
| Fax |
|
| Email |
srivatsa.sivakrishna@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Siva Prabodh |
| Designation |
M.D (Bio-chemistry) |
| Affiliation |
NRI Medical College & GH |
| Address |
VICE PRINCIPAL ACADEMIC SECTION , ROOM NO-3.
NRI Medical College & GH,
CHINNA KAKANI, GUNTUR DISTRICT.
Guntur
ANDHRA PRADESH
522503
India |
| Phone |
9849231126 |
| Fax |
|
| Email |
vuddandiprabodh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| NRI ACADEMY OF SCIENCES,
I P D OF N R I MEDICAL COLLEGE AND GENERAL HOSPITAL, CHINNA KAKANI GUNTUR ANDHRA PRADESH |
|
|
Primary Sponsor
|
| Name |
NRI ACADEMY OF SCIENCES |
| Address |
Chinna kakani, |
| Type of Sponsor |
Private medical college |
|
|
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 |
| DRKVSKUMAR CHOWDARY |
NRIMEDICAL COLLEGE |
I P D COVID WING, E N T DEPARTMENT, 8 ROOM NUMBER CHINNAKAKANI GUNTUR
Guntur
ANDHRA PRADESH |
7893451789
chowdaryent@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| N.R.I MEDICAL COLLEGE AND GENERAL HOSPITAL |
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, (2) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard Supportive Care |
These patients will be managed by standard supportive care. |
| Intervention |
Virunil 500mg Capsules |
1500mg per day in divided doses (3doses per day) with water.
for up to maximum of 10 days. Mode of Administration: Oral
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures.
Patient who are present in the stages of 1 and 2 of the COVID-19 disease. |
|
| ExclusionCriteria |
| Details |
1. Patients with Auto Immune Disorders.
2. Patients with Co morbid conditions such as Diabetes Mellitus and Hypertension.
3. Patients Under any kind of Anti-Cancer medication, Immunosuppressants.
4. Patients who are under anti-platelet medication.
5. Patients with history of Organ Transplantation.
6. Patients with compromised pulmonary function.
7. Patients receiving antiviral drugs.
8. Pregnant and lactating mothers are also excluded from the study.
9. Any other condition, where investigators jeopardize the outcomes of the trials
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The drug may reduce the hospital stay & inflammatory condition of COVID19 patients |
At base line, 7th day and 10th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Time from randomization to first time use of high flow supplemental oxygen/non-invasive ventilation/mechanical ventilation/ extracorporeal membrane oxygenation |
Randomization to hospital discharge (or day 28, which ever is earlier) |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/11/2020 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is undertaken to observe the efficacy
of Standardized marketed Ayurvedic formulation Maha Sudarshan Churna and
extracts of Tulasi, Turmeric and Garlic powders in the management of COVID-19
disease patients as an adjuvant therapy in subjects aged between 18 to 65 years
of both genders who are not having any substantial respiratory complications by
assessing the inflammatory markers like Interleukin-6(IL-6), High Sensitive C
reactive Protein(HSCRP), Lactate dehydrogenase(LDH), D-dimer, Ferritin,
Hs-Troponin–I, and Pro- calcitonin. If it proven efficient it will be very helpful as a supportive
therapy in these pandemic situation of covid 19. By this Ayurveda will play a
keyrole in supportive therapy of covid19.
|