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CTRI Number  CTRI/2020/05/025397 [Registered on: 28/05/2020] Trial Registered Prospectively
Last Modified On: 22/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to evaluate the effect and safety of a phytopharmaceutical drug in treatment of Coronavirus infection 
Scientific Title of Study   An open label, multicenter, randomized, controlled clinical trial to evaluate the efficacy and safety of Tablets of purified aqueous extract of Cocculus hirsutus in treatment of moderate COVID -19 disease 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
ICR/20/005; Version No. 1.0; Dated 01/MAY/2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shilpi Dhawan 
Designation  Head India Clinical Research 
Affiliation   
Address  Sun Pharma Laboratories Limited, Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon (E), Mumbai-400063, Maharashtra, India.

Mumbai
MAHARASHTRA
400063
India 
Phone  02243245299  
Fax  02243244343  
Email  shilpi.dhawan@sunpharma.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Maulik Doshi 
Designation  Medical Monitor 
Affiliation  Sun Pharma laboratories Limited 
Address  Sun Pharma laboratories Limited Tandalja, Vadodara-390020 Gujarat

Vadodara
GUJARAT
390020
India 
Phone  02656612829  
Fax  02652354897  
Email  maulik.doshi@sunpharma.com  
 
Details of Contact Person
Public Query  
Name  Guruprasad Palekar 
Designation  Deputy General Manager 
Affiliation  Sun Pharma Laboratories Limited 
Address  Sun Pharma Laboratories Limited Sun House, 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063

Mumbai
MAHARASHTRA
400063
India 
Phone  02243246215  
Fax  02243244343  
Email  guruprasad.palekar@sunpharma.com  
 
Source of Monetary or Material Support  
Sun Pharmaceutical Industries Limited Sun House, 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063  
 
Primary Sponsor  
Name  Sun Pharmaceutical Industries Limited 
Address  Sun Pharmaceutical Industries Limited Sun House, 201 B/1, Western Express Highway, Goregaon (E), Mumbai 400063  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 11  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Md Sabah Siddiqui  All India institute of medical science   Department of General Medicine, First floor, room no. 1111, All India Institute of Medical Sciences (AIIMS) ,GE Road Tatibandh Raipur-492099 Chhattisgarh,
Raipur
CHHATTISGARH 		 8518881911

dr.sabahsiddiqui@gmail.com 
Dr Rakesh Patil  Apex Hospitals  Department of General Medicine, OPD Block, Ground Floor, Apex Hospitals, Vaishali Heights, Chandavarkar Road, Borivali West, Mumbai- 400092, Maharashtra, India.
Mumbai
MAHARASHTRA 		 9867252786

rock4udoc@gmail.com 
Dr Kartikeya Parmar  B.J. Medical College and Civil hospital,  First floor Department of Medicine, B.J. Medical College and Civil hospital, Asarwa, Ahmedabad-380016,Gujarat,India
Ahmadabad
GUJARAT 		 9924643799

drkartik@gmail.com 
Dr Shivakumar Sankaranarayanan Iyer  Bharati Hospital & Research Centre  2nd Floor, Dept of Critical Care Medicine, Bharati Hospital & Research Centre, Bharati Vidyapeeth (deemed to be) University Medical College,  Pune-Satara Road, Dhankawadi, Pune 411043
Pune
MAHARASHTRA 		 9822051719

shivkumar.iyer@bharatihospital.com 
Dr Rohit Parate  Chirayu Medical College and Hospital  Department of Medicine, Ground Floor, Chirayu Medical College and Hospital, Bhopal Indore Highway, near Bairagarh, Bhopal, Madhya Pradesh- 462030
Bhopal
MADHYA PRADESH 		 9630033342

rohitparate963@gmail.com 
Dr MRS GIRIJA NAIR  Padmashree Dr D Y Patil Medical College Hospital & Research Center   1st Floor, OPD 69, Department of Pulmonary Medicine Padmashree Dr D Y Patil Medical College Hospital & Research Center, Plot No. 2 Sector 5,Nerul,Navi Mumbai 400706
Mumbai
MAHARASHTRA 		 9324294457

girijapn@hotmail.com 
Dr K Vengadakrishnan  Sri Ramachandra Institute of Higher Education and Research (DU) Clinical Research Division  "Department of General Medicine, Link Room No 1, G Block, Sri Ramachandra Institute of Higher Education and Research (DU) Clinical Research Division, Dental College Basement, No.1, Ramachandra Nagar, Porur, Chennai- 600116, Tamil Nadu, India
Chennai
TAMIL NADU 		 9840131906

drkvk1975@gmail.com 
Dr Khobragade Akash Ashokkumar  St. George’s Hospital  First Floor,Medical Superintendent Office, St. George’s Hospital, P D’Mello Road, Behind GPO, Fort, Mumbai-400001.
Mumbai
MAHARASHTRA 		 9702658822

drakashk.research@gmail.com 
Dr Rajadhyaksha Girish Chandrakant  T.N. Medical College & B.Y.L. Nair Ch. Hospital  Room No. 104 ,1st Floor Medicine Department , College Building , T.N. Medical College & B.Y.L. Nair Ch. Hospital, Mumbai Central, Mumbai- 400 008
Mumbai
MAHARASHTRA 		 8921695349

girishraj63@hotmail.com 
Dr Shashi Bhushan B L  Victoria Hospital, Bangalore Medical College and Research Institute  Department of Pulmonology, B Block, Ground Floor, Victoria Hospital, Bangalore Medical College and Research Institute, Fort, K R Road, Bangalore Urban, Karnataka - 560002, India
Bangalore
KARNATAKA 		 9448239644

shashibhushanbl@yahoo.com 
Dr Halnor Dnyaneshwar Machhindra  Vijay Vallabj Hospital and Medical Research Center  Vijay Vallabj Hospital and Medical Research Center, Room No. 405, Clinical Research Department, 4th floor, Plot No. 423, Tirupati Nagar, Phase 1, Bolinj, Virar (West), Distt-Palghar, Pincode - 401303
Mumbai
MAHARASHTRA 		 7507779219

halnordnyanu@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 11  
Name of Committee  Approval Status 
Ethics Committee of Bangalore medical college and research institute  Approved 
Institutional Ethics Committee Gandhi Medical College and Hamidia Hospital  Approved 
Institutional Ethics Committee TNMC NAIR HOSPITAL  Approved 
Institutional Ethics Committee, All India institute of medical science  Approved 
Institutional Ethics Committee, BVDU Bharati Hospital and Research Centre  Approved 
Institutional Ethics Committee, D Y Patil Medical College  Approved 
Institutional Ethics Committee, GGMC  Approved 
Institutional Ethics Committee, SRIHER  Approved 
Institutional Ethics Committee, Vijay Vallabh Hospital  Approved 
Institutional Ethics Committtee, Vijay Vallabh Hospital  Approved 
The Institutional Ethics Committee, B J Medical college and and civil hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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 
Intervention  Purified aqueous extract of Cocculus hirsutus (AQCH) tablets  400 mg thrice daily (every 8±1 hours), 10 days Dosage and Administration: Thrice daily at least 30 min before meal, preferably at the same time every day. Patient will also be given standard of care as per institutional practice. 
Comparator Agent  Standard of care as per institutional practice  Standard of care as per institutional practice 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Subjects will be included in the study if they meet all of the following criteria:
1. Patient who provides written informed consent
2. Male or non-pregnant, non-lactating female patient aged ≥ 18 and ≤ 75 years (both inclusive)
3. Patients with body temperature > 37.3℃ with cough/ shortness of breath
4. Patient with moderate COVID-19 infection having either one of the following criteria
a. PaO2/ FiO2: 200-300
OR
b. Respiratory Rate > 24/min and SaO2/ SpO2 ≤ 93% on room air
5. Patient with RT-PCR confirmed diagnosis of COVID-19
6. Patient who is able to take the drug orally and comply with study procedures
7. Women of childbearing potential must have a negative urine pregnancy test prior to study entry
 
 
ExclusionCriteria 
Details  Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria:
1. Patient with persistent vomiting
2. Patient with known active hepatitis, tuberculosis and definite bacterial or fungal infections
3. Patient with altered mental state
4. Patient with multiple organ failure requiring ICU monitoring and the treatment
5. Patient with respiratory failure and requiring ventilation
6. Patient with history of retinopathy or macular degeneration
7. Patient with history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
8. Patient with prolonged QTc-interval at baseline ECG (>450 ms in males or > 470 ms in females)
9. Patient taking concomitant medication associated with QTc-interval prolongation, which cannot be withdrawn prior to study drug administration
10. Patient with history of hypersensitivity towards any drug of standard of care
11. Patient with history of evidence of chronic interstitial infiltration at imaging
12. Patient with history of hospitalization within the past six months for respiratory failure
13. Patients with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., heart failure, COPD, hypertension, liver disease, chronic respiratory failure, chronic kidney disease, diabetes, anaemia etc.) that, in the opinion of the Investigator precludes the subject’s participation in the study or interferes with the interpretation of the study results.
14. Patient with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus.
15. Patient who has received specific antiviral drugs ritonavir/ lopinavir, or chloroquine,
hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week prior to admission
16. Patient who has participated in another investigational study within 3 months prior to enrolment in this study.
17. Investigators, study personnel, sponsor’s representatives and their first degree relatives.
Note: Persistent vomiting is more than three episodes of vomiting in 12 hours, preventing adequate oral
hydration 
 
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 
Proportion of patients showing clinical improvement
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.
Hospital Discharge Criteria is defined as resolution of symptoms, radiological improvement with a documented virological clearance in 2 samples at least 24 hours apart. 		 Day 14 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of patients showing clinical improvement  Day 7 and Day 28 
Time (Days) to clinical improvement   upto 28 days 
Time to normalization of fever without use of antipyretics in last 24 hours   upto 28 days 
Time to alleviation of cough   upto 28 days 
Time to first negative SARS-CoV-2 RT-PCR in in upper or lower respiratory tract specimen  upto 28 days 
Duration (days) of supplemental oxygen therapy  upto 28 days 
Proportion of patients showing deterioration of clinical condition as assessed by at least 1 point worsening on 7 point ordinal scale (non-invasive ventilation, mechanical ventilation, ECMO or death)   upto 28 days 
Duration (days) of hospitalization  upto 28 days 
Number of deaths (All cause mortality)   upto Day 28 
Safety evaluation, as measured by AEs, Adverse Reactions (ARs), SAEs, Serious ARs (SARs)  upto 28 days 
 
Target Sample Size   Total Sample Size="210"
Sample Size from India="210" 
Final Enrollment numbers achieved (Total)= "210"
Final Enrollment numbers achieved (India)="210" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  		 05/06/2020 
Date of Study Completion (India) 19/08/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

This is an open label, randomized, comparative, multi-centre, parallel group, controlled clinical study. This study is being conducted across multiple centers in India. 

 
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