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CTRI Number  CTRI/2020/05/025326 [Registered on: 23/05/2020] Trial Registered Prospectively
Last Modified On: 14/09/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study
Modification(s)  		 Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Tablet PINAK given as treatment to COVID positive patients. 
Scientific Title of Study   Ayurvedic proprietary adjuvant oral intervention Tab PINAK for COVID patients towards early recovery. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shreepad Bhat 
Designation  HOD Medicine 
Affiliation  Smt. Kashibai Navale Medical College and General Hospital 
Address  49/1 Off Mumbai Pune Bypass, Narhe Pune Maharashtra

Pune
MAHARASHTRA
411041
India 
Phone  9850470067  
Fax    
Email  suprabhatdiabetes@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pandurang Pawar 
Designation  Consultant 
Affiliation  Shree Bharadi Ayurvedic Pharamaceuticals 
Address  207 I Shaniwar Peth Shahu Chowk Karad 415110

Satara
MAHARASHTRA
415110
India 
Phone  8830207186  
Fax    
Email  drpandurangpawar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pandurang Pawar 
Designation  Consultant 
Affiliation  Shree Bharadi Ayurvedic Pharamaceuticals 
Address  207 I Shaniwar Peth Shahu Chowk Karad 415110

Satara
MAHARASHTRA
415110
India 
Phone  8830207186  
Fax    
Email  drpandurangpawar@gmail.com  
 
Source of Monetary or Material Support  
Shree Bharadi Ayurvedic Pharamaceuticals 207 I Shaniwar Peth Shahu Chowk Karad 415110 
 
Primary Sponsor  
Name  Shree Bharadi Ayurvedic 
Address  Pharamaceuticals 207 I Shaniwar Peth Shahu Chowk Karad 415110 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pandurang Pawar  SKNMC and GH  COVID WARD 49/1 Off Mumbai Pune Bypass Narhe Pune Maharashtra 411041
Pune
MAHARASHTRA 		 8830207186

drpandurangpawar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
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, (2) ICD-10 Condition: B342||Coronavirus infection, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not applicable 
Intervention  Tab PINAK  Moderate to severe disease: 2 Stat; plus 1 QID x 5 days: Mild: 1 TDS X 5 days. If required to be continued: maximum 14 days intervention 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients reporting positive for COVID infection in COVID wsrd of SKNMC and GH Pune 
 
ExclusionCriteria 
Details  Below 18 years of age, Pregnant and lactating women; Patients in ICU under ventilator. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Early recovery and reduced mortality  Day 15 
 
Secondary Outcome  
Outcome  TimePoints 
Hospital stay reduced  Day 15 or at discharge for any reason. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "106"
Final Enrollment numbers achieved (India)="106" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   31/05/2020 
Date of Study Completion (India) 17/09/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 International Journal of Pharmaceutical Research and Appliation Volume 6 Issue 6 November December 2021 82 to 93  
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  DATA CAN BE MADE AVAILABLE ON REQUEST ON MAIL drpandurangpawar@gmail.com

  6. For how long will this data be available start date provided 01-11-2020 and end date provided 01-11-2025?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - IPD SHARING CAN BE DONE WITH GOVERNMENT OR INTERESTED PERSON
Brief Summary
Modification(s)  		 Summery

During this pandemic many countries suffered worst epidemic with lacks of people suffering  and thousands dying from Covid 19. Fear spread across globe as there was no medical cure of the disease. There was high death rate initially, as Covid 19 was unknown. Researchers all over the world started to try and find a medical treatment for Covid 19. Possible mode of action of Pinak in snake bite s is by neutralizing the protein venom as seen from the various snake bite studies. Covid 19 attaches to host cells by S proteins. Pinak makes it ineffective nullifying virus.
Present pilot study was conducted in SKNMC & GH Medicine department in Covid hospital from 22 05 2020 to 17 09 2020. Patients admitted in Covid ward and ICU those were Covid positive are enrolled in Study group (n = 38) and Control group (n = 30) in Mild category and in Study group (n = 19) and Control group (n = 19) in Moderate and Severe category. This study was undertaken with Primary Objective of Recovery from Covid 19 when used as adjuvant therapy along with protocol drugs,
Significantly Early Recovery in patients who had taken PINAK as compared to Control group is seen. On 3rd day 72.73% vs. 11.11%, on 5th day 95.45% vs, 38.89% and on 7th day 100% vs, 61.11% recovery is seen respectively.
In Mild symptomatic group, Pinak study group required 3.14 days and Control group required 6.39 days for recovery.
CONCLUSIONS
1  EARLIER the institution of Pinak, FASTER is the Recovery.
2  Pinak reduces time required to become symptom free.
3  Average Ventilatory time or O2 time in Study group with Pinak is 4.7 days. While in Control group it is 15 days. t = - 2.77, p < 0.05
4  Average stay of patients from Moderately Severe group is 14.37 days in Pinak study group and 22.6 days in Control group. t = - 2.53, p < 0.05
5  Post study treatment of thousands of patients of Covid 19 with ONLY tablet PINAK showed that this VIRAL POISONING should be treated like SNAKE VENOM POISONING giving MAXIMUM DOSAGE IN FIRST 24 HOURS to get REQUIRED FASTEST RESULTS.
We confirm that there are no conflicts of interest associated with this publication and there is no financial support for this trial that could have influenced its outcome.

 
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