CTRI Number	CTRI/2020/04/024883 [Registered on: 28/04/2020] Trial Registered Prospectively
Last Modified On:	21/12/2022
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)
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  DrJHareendran Nair  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 Contact Person Scientific Query Modification(s)	Name  Dr Shan Sasidharan  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 Contact Person Public Query	Name  DrJHareendran Nair  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 Modification(s)	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   Contact Person  Name of Site  Site Address  Phone/Fax/Email  DrSonali Nirhali  Lifepoint multispecialty hospital  Lifepoint multispecialty hospital, wakad,Pune Maharashtra 411057 Pune   7506213126 sonalinirhali26@gmail.com  Dr Madhukumar  Mysore Medical college and Research Institute  Mysore pin 5760001 Mysore   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   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   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 Modification(s)	Health Type  Condition  Patients  Coronavirus as the cause of diseases classified elsewhere
Intervention / Comparator Agent Modification(s)	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 Modification(s)	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"
Phase of Trial	Phase 4
Date of First Enrollment (India) Modification(s)	29/04/2020
Date of First Enrollment (Global)	No Date Specified
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 Modification(s)	Sasidharan S, Nair J H, K P S, Paul J, R MK, Rajendran K, Saibannavar AA, Nirali S. An efficacy and safety report based on randomized controlled single-blinded multi-centre clinical trial of ZingiVir-H, a novel herbo-mineral formulation designed as an add-on therapy in adult patients with mild to moderate COVID-19. PLoS One. 2022 Dec 6;17(12):e0276773. doi: 10.1371/journal.pone.0276773. PMID: 36472969; PMCID: PMC9725144.
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.