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CTRI Number  CTRI/2020/04/024883 [Registered on: 28/04/2020] Trial Registered Prospectively
Last Modified On: 06/05/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Other 
Public Title of Study   Clinical research on safety and efficacy of ZingiVir-H as an add on therapy in COVID-19 patients. 
Scientific Title of Study   Randomized controlled Single blinded prospective multi centre clinical trial to investigate the safety and efficacy of ZingiVir-H as an adjuvant therapy in hospitalized adults diagnosed with coronavirus disease 2019 (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  DrJHareendran Nair 
Designation  Managing Director and Founder 
Affiliation  Pankajakasthuri Herbal research Foundation 
Address  Pankajakasthuri Herbal research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum
Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum
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 and PG centre Kattakkada Trivandrum
Pankajakasthuri Ayurveda Medical college and PG centre Kattakkada Trivandrum
Thiruvananthapuram
KERALA
695572
India 
Phone  9188325339  
Fax    
Email  drshan@pkhil.com  
 
Details of Contact Person
Public Query
 
Name  DrJHareendran Nair 
Designation  Managing Director and Founder 
Affiliation  Pankajakasthuri Herbal research Foundation 
Address  Pankajakasthuri Herbal research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum
Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum
Thiruvananthapuram
KERALA
695572
India 
Phone  9447096201  
Fax    
Email  md@pkhil.com  
 
Source of Monetary or Material Support  
Pankajakasthuri Herbal research Foundation. Pankajakasthuri medical college , Kattakkada, Thiruvananthapuram, Pin 695572, Kerala 
 
Primary Sponsor  
Name  Pankajakasthuri herbal research foundation 
Address  Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSonali Nirhali  Lifepoint multispecialty hospital  Lifepoint multispecialty hospital, wakad,Pune Maharashtra 411057
Pune
MAHARASHTRA 
7506213126

sonalinirhali26@gmail.com 
Dr Madhukumar  Mysore Medical college and Research Institute  Mysore pin 5760001
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 medical college and Hospital, saveetha university, chennai 602105
Chennai
TAMIL NADU 
9710071284

dr.seeni23@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee2(RCSMGMCIEC2),Rajarshee Chhatrapati Shahu Maharaj Government Medical College and Chhatrapati Pramila Raje Hospital,Kolhapur  Approved 
Lifepoint research Ethics committee,Wakad, Pune   Approved 
Mysore medical college &Research institute  Approved 
Saveetha Medical college and Hospital Institutional ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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  It is a poly herbomineral drug.Therapeutic dose: 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) for a minimum duration of 10 days to Maximum 15 days as per the clinical conditions and disease outcome. 
 
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.
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-CoV)-2 infection
confirmed by RT Polymerase chain reaction (RT-PCR) test between 1 and 120 Hours
before randomization
4. Currently hospitalized and requiring medical care for COVID-19
5. Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening
6. Radiographic evidence of pulmonary infiltrates 
 
ExclusionCriteria 
Details  Candidates for the study will be excluded if ANY of the following criteria are present:
1. Subject or Authorized Representative is unable to provide informed consent
2. Subject is pregnant or breastfeeding ladies
3. Subject is of childbearing potential and has a positive pregnancy test since admission to
the hospital
4. Subject is < 18 years of age
5. Subject has a known allergy to herbal compounds or ZingiVir-H or any components of
the drug product
6. Subject has had previous treatment with ZingiVir-H
7. Body weight ≥ 175 kg
8. Intra-thoracic or intra-abdominal surgery within the 12 hours prior to consent, or ongoing
impairment of hemostasis as a result of one of these procedures
9. A history of head trauma, spinal trauma, or other acute trauma with an increased risk of
bleeding.
10. Cerebral Vascular Accident (CVA) or Intracerebral Arteriovenous Malformation (AVM),
cerebral aneurysm, or mass lesions of the central nervous system or melena,
hematemesis.
11. Inability to take oral medication
12. Prolonged QTc-interval in baseline ECG (>500 ms)
13. History of solid organ, allogeneic bone marrow, or stem cell transplantation.
14. Severe renal failure characterized by chronic or acute need of hemodialysis,
hemofiltration or peritoneal dialysis
15. Need of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics during the
treatment period.
16. Participation in another research study involving an investigational agent within 30 days prior to consent  
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 15 [Time Frame: Day 15 from the day of study inclusion]. The odds ratio represents the odds of improvement in the ordinal scale between the treatment groups. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded.
 
Baseline ,Day 7 and Day 15 
 
Secondary Outcome  
Outcome  TimePoints 
To find out the anti pyretic activity of ZingiVir H  During the therapy. 
 
Target Sample Size   Total Sample Size="112"
Sample Size from India="112" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="116" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   29/04/2020 
Date of Study Completion (India) 24/08/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

The present clinical trial was carried out primarily to investigate the safety and efficacy of ZingiVir-H, the study drug, as an adjuvant therapy in hospitalized adults diagnosed with COVID-19.

A total of 116 randomized patients were assessed for the present analysis; 58 patients were assigned to ZingiVir-H group and 58 patients to the Placebo group. All the study patients assigned to receive study drug or placebo along with standard of care treatment as per hospital policy and National COVID-19 treatment protocol. The time to clinical improvement was assessed after all patients who were tested negative for RT-PCR after the treatment with ZingiVir-H (3 g/day) or Placebo for at least ten days duration. Safety profile of ZingiVir-H was assessed by liver and renal function tests.

From the study, it was observed that those patients received ZingiVir-H had a median recovery time of 5 days (95% Confidence interval (CI) 5-5) as compared with 6 days (95% CI 5-6) in those who received Placebo. The overall median recovery time from COVID-19 is also evaluated and it is observed as 5 days (95% CI 5-6) for the ZingiVir-H group. The body temperature of the patients was measured on the Day 1, 3 and 5 of the trial. Even though, the temperature is not showing significant difference over three-time points corresponding to Placebo and ZingiVir-H, but the P value corresponding to ZingiVir-H is less than that of Placebo suggesting ZingiVir-H is reducing the temperature better than Placebo. Results of the safety profile showed that ZingiVir-H recorded no undesirable effect or impairment to liver and kidney functions. No serious adverse events (SAE) or adverse drug reaction were reported on the ZingiVir-H treated patients.


 
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