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
|
|
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.
|