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CTRI Number  CTRI/2020/07/026700 [Registered on: 20/07/2020] Trial Registered Prospectively
Last Modified On: 28/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Rasayana therapy ]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Ayurvedic Rasayana therapies  
Scientific Title of Study   A randomized placebo controlled multicentric study to evaluate the efficacy and safety of Ayurvedic formulation as an immunomodulator in reducing the risk of COVID 19 infection or severe stage coronavirus disease in Healthcare workers involved in care of patients with Coronavirus disease 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Avinash Kadam  
Designation  Project Coordinator  
Affiliation  Ayurved Rasayani  
Address  Depertment of Clinical Research Ayurved Rasayani Mhalunge Nande Road Mhalunge Padale Tal Mulshi Dist Pune

Pune
MAHARASHTRA
411045
India 
Phone  9970259583  
Fax  00  
Email  avinashk@rbpl.co.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Avinash Kadam  
Designation  Project Coordinator  
Affiliation  Ayurved Rasayani  
Address  Depertment of Clinical Resrach Ayurved Rasayani Mhalunge Nande Road Mhalunge Padale Tal Mulshi Dist Pune

Pune
MAHARASHTRA
411045
India 
Phone  9970259583  
Fax  00  
Email  avinashk@rbpl.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Avinash Kadam  
Designation  Project Coordinator  
Affiliation  Ayurved Rasayani  
Address  Depertment of Clinical Resrach Ayurved Rasayani Mhalunge Nande Road Mhalunge Padale Tal Mulshi Dist Pune

Pune
MAHARASHTRA
411045
India 
Phone  9970259583  
Fax  00  
Email  avinashk@rbpl.co.in  
 
Source of Monetary or Material Support  
Ayurved Rasayani . Nande Mahalunge Roda Mahalunge. Pune 
 
Primary Sponsor  
Name  Ayurved Rasayani  
Address  Mhalunge Nande Road Mhalunge Padale Tal Mulshi Dist Pune 411045 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Not Applicable   Not Applicable  
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrMeenakshi Bhakare  Symbiosis Medical collage for woman   Depertment of Respiratory medcine Symbiosis Medical Collage At Post Lavale Tal.Mulshi Di-Pune
Pune
MAHARASHTRA 
9096555775

hod.respiratorymedicine@smcw.siu.edu.in 
Dr Deepali Ambike   Yashwantrao Chavan Memorial Hospital YCM Hospital Rd Sant Tukaram Nagar Pimpri Colony Pune   Depertment of Paediatrics Yashwantrao Chavan Memorial Hospital YCM Hospital Rd Sant Tukaram Nagar Pimpri Colony Pune
Pune
MAHARASHTRA 
9373002072
00
ambikedeepa@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC of SIU  Submittted/Under Review 
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 
Intervention  Ayurveda formulation  Capsule Pranvir : 2 capsules twice daily with warm water. Capsule Yasada Rasayana: 1 capsule twice daily with warm waterfor 60 days 
Comparator Agent  Placebo  Placebo similar to Pranvir and Yasada for 60 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 18 years or older

2 If an individual has come in close contact with someone who has been diagnosed with COVID 19 with last exposure within the last 4 days and do not have any symptoms or
3 A healthcare worker involved in care of patients with Coronavirus disease

 
 
ExclusionCriteria 
Details  1 Immunocompromised patients or patients receiving immuno-compromised medications
2 Patients with active malignancy or undergoing anticancer therapies
3 Pregnant women or women who are breastfeeding
4 Consideration by the investigator for any reason that the subject is an unsuitable
5 candidate to receive study treatment
Patients not willing to participate in study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate if Ayurveda Rasayana therapy can prevent symptomatic coronavirus disease or
severe corona virus disease after known exposure to the SARS-CoV-2 coronavirus 
Day 1
Day 30 and
Day 60  
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of Pro inflammatory cytokines.
Disease severity on an ordinal scale.
Length of time to clinical improvement and clinical progression
Evaluation of D-dimer
Length of time to normalization of fever, normalization of oxygen
Duration of supplemental oxygen and /mechanical ventilation
Number of participants that developed ARDS
Duration required to get COVID-19 PCR test negative
Duration of hospitalization /or ICU stay
Percent mortality
 
Till day 60 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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   N/A 
Date of First Enrollment (India)   27/07/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Hypothesis:
SARS-CoV-2 is a rapidly spreading viral infection causing coronavirus disease. The current strategy for dealing with this pandemic is to identify infected cases and their contacts, screening, isolation, and quarantine to stop spread of the disease. Post exposure to COVID -19 the standard of care is observation of the individual under quarantined condition. Therapy is generally not given to persons who are not hospitalized.
Ayurveda medicines have a long-term history of use in clinics for overall immunity building. This has created evidence for its efficacy in various respiratory disorders and also safety is demonstrated.
Administration of oral Ayurveda Rasayana formulations will help reduce the risk of development of symptomatic corona virus disease or can prevent disease progression, thereby decreasing hospitalizations and symptoms severity.

 
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