| CTRI Number |
CTRI/2020/05/025434 [Registered on: 29/05/2020] Trial Registered Prospectively |
| Last Modified On: |
10/08/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to evaluate the Medicinal effects of ZingiVir-H as Anti-Viral therapy in COVID-19 patients. |
|
Scientific Title of Study
|
Randomized, double-blind, placebo-controlled
prospective multicenter trial to validate the
safety and efficacy of an antiviral drug
zingivir-h, in adults with asymptomatic, mild or
moderate nCOVID-19 infection.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrJHareendran Nair |
| Designation |
Managing Director and Founder |
| Affiliation |
Pankajakasthuri Herbal research Foundation |
| Address |
Pankajakasthuri Herbal research Foundation
Pankajakasthuri Ayurveda Medical college and P.G centre
695572
India
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9447096201 |
| Fax |
|
| Email |
md@pkhil.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shan Sasidharan |
| Designation |
Director Research and Development |
| Affiliation |
Pankajakasthuri Herbal research Foundation |
| Address |
Pankajakasthuri Herbal research Foundation
Pankajakasthuri Ayurveda Medical college
Kerala
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9188325339 |
| Fax |
|
| Email |
drshan@pkhil.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr J Hareendran Nair |
| Designation |
Managing Director and Founder |
| Affiliation |
Pankajakasthuri Herbal Research Foundation |
| Address |
Pankajakasthuri Herbal research Foundation
Pankajakasthuri Ayurveda Medical college and PG centre
Thiruvananthapuram
KERALA
695572
India |
| Phone |
9447096201 |
| Fax |
|
| Email |
md@pkhil.com |
|
|
Source of Monetary or Material Support
|
| Pankajakasthuri Herbal Research Foundation,
Kattakkada,
Thiruvananthapuram
Kerala Pin 695572 |
|
|
Primary Sponsor
|
| Name |
Pankajakasthuri herbal research foundation |
| Address |
Pankajakasthuri Herbal research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada Thiruvananthapuram
Kerala |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sunilkumar |
Datta Meghe Institute of Medical sciences |
Dept. of Medicine,Acharya Vonoba bhave Rural Hospital,Datta Meghe Institute of Medical sciences,Sawangi(Meghe),Wardha 442004
Wardha
MAHARASHTRA |
9850393787
sunilkumarmed@gmail.com |
| DrSalim Sheikh |
ESIC Medical college and Hospital,Faridabad, Haryana |
ESIC Medical college and Hospital,Faridabad, Haryana 121001
Faridabad
HARYANA |
8470923822
drsalimsheikh@gmail.com |
| Dr Madhukumar |
Mysore Medical college and Research Institute |
Dept.of General Medicine
KR hospital.Mysore medical college & research Institute
Mysore
KARNATAKA |
9743105248
drkumarmadhu9@gmail.com |
| Dr Anita Ajit Saibannavar |
Rajarshee Chatrapati Shahu Maharaj Government Medical College |
CROM clinical Research & Medical tourism pvt ltd at Rajarshee Chatrapati Shahu Maharaj Government Medical College & Chhatrapati Pramila Raje General Hospital, Town Hall ,Bhausinghaji Road, Dasara Chowk
Kolhapur
MAHARASHTRA |
7720092701
rcsmgmc.research@gmail.com |
| DrKannan Rajendran |
Saveetha medical college and Hospital, saveetha university, chennai |
Saveetha university
Chennai 602105
Chennai
TAMIL NADU |
9710071284
endork@yahoo.com |
| Dr Poorna Prasad |
Sri Venkateshwara hospitals |
27,29 th Main Road, Rashtra Kuvempu Nagar,BTM 2 nd stage ,BTM layout, Bengaluru
Bangalore
KARNATAKA |
08025630006
poorash11@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Balaji Independent Ethics committee |
Approved |
| Institutional Ethics Committe,Sri Venkateshwara Hospitals, Bengaluru |
Submittted/Under Review |
| Institutional Ethics committee Human Research Transalational health science and technology Institute |
Submittted/Under Review |
| Institutional ethics committee, Datta Meghe Institute of medical Sciences ,Wardha |
Approved |
| Mysore medical college &Research institute |
Approved |
| Rajarshee Chhatrapati Shahu Maharaj Government Medical college and Chhatrapati Pramila Raje General Hospital |
Approved |
| Saveetha Medical college and Hospital Institutional 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 |
not applicable |
Not applicable |
| Intervention |
Zingivir-H |
- ONE tablet (500 mg) each consumed once in 3 hours ±1 hour between 6 AM and 9 PM in a given day (6AM, 9AM, 12Noon, 3PM, 6PM, 9PM) totally six tablets per day for a minimum duration of 10 days to Maximum 15 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of both sexes aged from 18 years to 60 years old.
2 Willing and able to provide written informed consent prior to performing study procedures by the subject or legal guardian willing and able to provide written informed consent prior to performing study procedures
3.Patients with Severe Acute Respiratory Syndrome Coronavirus SARS-CoV2 COVID infection confirmed by RT Polymerase chain reaction RT-PCR test
a PCR positive in sample collected 96 hours prior to randomization OR
b PCR positive in sample collected 96 hours prior to randomization documented inability to obtain a repeat sample e.g. due to lack of testing supplies limited testing capacity results taking 24 hours or any other documented reasons etc. AND progressive disease suggestive of ongoing SARS-CoV-2 infection.
4.Currently hospitalized and requiring medical care for COVID-19
5.Peripheral capillary oxygen saturation SpO2 94 percentage on room air at screening
6.Radiographic evidence of pulmonary infiltrates OPTIONAL Criteria
|
|
| ExclusionCriteria |
| Details |
1.Any of the following would exclude the subject from participation in the study:
2.Subject or Authorized Representative is unable to provide informed consent
3.Subject is pregnant or breastfeeding ladies
4.Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital
5.Acute illness (defined as the presence of moderate or severe signs and symptoms related with the COVID infection) at the time of randomization
6.Any current or expected receipt of immunosuppressive agents including steroids (except for the use of topical steroids according to the judgment of the investigator)
7.History of receipt of blood transfusion or immunoglobulin products or expected receipt through the duration of the study
8.Known hepatic dysfunction including known or suspected active or chronic hepatitis infection
9.History of CLD/ bronchopulmonary dysplasia
10.Clinically significant congenital anomaly of the respiratory tract
11.Inability to take oral medication
12.Prolonged QTc-interval in baseline ECG (>500 ms)
13.Severe renal failure characterized by chronic or acute need of hemodialysis, hemofiltration or peritoneal dialysis
14.Need of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics during the treatment period.
15.Participation in another research study involving an investigational agent within 30 days prior to consent
16.Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
The odds of ratio for improvement on a 7 point ordinal scale on Day 15 and clearance of medically attended lung infection due to RT-PCR confirmed COVID19 infection , in Zingivir H treated group to the placebo group.
|
base line , 7 th day, 15 th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improved clinical condition without significant AEs , less hospital stay and changes from baseline in heamatological, biochemical and inflammatory blood markers. |
Baseline 7 th day 14 th day and 20 th day |
|
|
Target Sample Size
|
Total Sample Size="135"
Sample Size from India="135"
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)
|
31/05/2020 |
| 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
|
No publications done so far |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Covid 19 is now spreading throughout the world because of its high infectivity and communicability. Also there is lack in the proper management of the disease.So any contribution in the knowledge of treatment of covid 19 from any source could be of great value to the medical profession. Thus the present study is proposed to understand the safety and efficacy of the study drug Zingivr-H in the patients infected with SARS COV2/COVID 19 INFECTION. The study drug is a poly herbo mineral formulation, which is a blend of antiviral phytomolecules and processed purified and detoxified form of natural metallic compounds.The study drug with systematic herbal formulation with appropriate combination is believed to have remarkable antiviral, antipyretic, immunomodulatory effects in treating patients. In the present randomised controlled, double blinded multi centric study, the study drug Zingivir H is proposed as standalone anti viral therapy in hospitalised adults diagnosed with COVID 19 .At inclusion adult subjects who meet all inclusion criteria with COVID 19 positive assessment and with or without mild COVID 19 infection related symptoms shall be screened into the study and will be assigned either therapeutic arm or placebo arm (2:1 ratio.)Patients with co morbidities like diabetes mellitus,hypertension,Dyslipidimia,CAD, or any metabolic / functional disorders shall be allowed to continue with concomitant medications for the co morbidity along with the study drug or placebo.No antibiotics , anti viral or any drugs which may interfere in the possible intervention or allevation of COVID 19 infection can be prescribed for the study participants up to day 15 ( end of the treatment ) from the day of enrollment or until the study drug treatment is ON.If the study participant shows the increase in the body temperature after inclusion in the study shall be prescribed by a twice daily dose of 500 mg of NSAID and/ or protective dose of Vitamin C up to 150 mg per day and /or Zinc tablets up to 40 mg per day which is truly based on investigator’s discretion. if the study participant shows hypoxemic respiratory failure (type 1 ) after inclusion in the study shall be supported by oxygen supply and when required , which is truly based on investigator’s discretion. whereas if the study participants health condition worsens from baseline assessment and after the inclusion in the study assessed through 7 point ordinal scale of improvement referred elsewhere in the protocol , and if the study participant deemed requires alternate therapy and procedures, the investigators can withdraw the study subject from the treatment and continue with the available standard of care. Once after randomization in the study the blood samples shall be drawn on day 01, day 07 or on the day of COVID 19 negative and discharge from the hospital , whichever comes earlier , Day 15 and Day20 to understand the safety and efficacy profile.The study drug does not contain any harsh chemicals and thus there is no adverse reactions expected.Due to the presence of purified and detoxified herbo minerals , there may be chances of mild gastritis,change in bowel movements and mild acidity. Dose of HgS and As2S3 is designed in such a way that there is no cumulative dose sufficient for making any type of toxicity in the continuous usage more a maximum period of 15 days . Safety assessments shall be done by assessing any adverse events or SAE in the study patients from day 01 until Day20 . Paper CRF shall be used in the study for data collection. Statistical analysis shall be done as per Intent to Treat (ITT) and the study results shall be modeled and published . A clinical study report shall be prepared and will be submitted to relevant regulatory authorities. |