FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2022/01/039370 [Registered on: 12/01/2022] Trial Registered Prospectively
Last Modified On: 23/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Efficacy of Ayush medicine NOQ19 in treatment of COVID-19 patients 
Scientific Title of Study
Modification(s)  		 A randomized, double blind, placebo controlled, trial to determine the therapeutic efficacy of Ayush medicine NF2 in treatment of symptomatic COVID-19 patients along with standard allopathic treatment 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Amit Gupta 
Designation  Director 
Affiliation  Center for Diabetes Care 
Address  Room No.-G9 Krishna Apra Plaza near Axis Bank Alpha-I Commercial Belt Alpha 1

Gautam Buddha Nagar
UTTAR PRADESH
201308
India 
Phone  9891718374  
Fax    
Email  dramitaol@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anurag Srivastava 
Designation  Assistant Professer 
Affiliation  Government Institute of Medical Science 
Address  Room No.- 104 Department Of Community Medicine Government Institute for Medical Science GIMS Greater Noida

Gautam Buddha Nagar
UTTAR PRADESH
201310
India 
Phone  9415061563  
Fax    
Email  dranurag23@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vimal Narayanan 
Designation  Scientist 
Affiliation  Sri Sri Institute For Advanced Research 
Address  Room No.- 202 Ayush Research Sri Sri Institute for Advanced Research Kanakapura Road Udayapura P O Bengaluru

Bangalore
KARNATAKA
560082
India 
Phone  9910910031  
Fax    
Email  vimal.n@ssiar.org  
 
Source of Monetary or Material Support  
Sriveda Satva Pvt. Ltd. Kanakapur Road Udayapura P O Bangaluru Karnataka 560082 
 
Primary Sponsor  
Name  Sriveda Sattva Private limited 
Address  21st KM, Kanakapura Road, Udayapura, Bangalore South, Karnataka-560 082, India 
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 Anurag Srivastava  Government Institute for Medical Science  COVID Care Center, Department Of Community Medicine GIMS Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH 		 9415061563

dranurag23@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
GIMS INSTITUTIONAL ETHICS COMMITTEE GREATER NOIDA  Approved 
GIMS INSTITUTIONAL ETHICS COMMITTEE GREATER NOIDA  Approved 
GIMS INSTITUTIONAL ETHICS COMMITTEE GREATER NOIDA  Approved 
GIMS INSTITUTIONAL ETHICS COMMITTEE GREATER NOIDA  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. Ayurveda Condition: COVID19,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugOther than Classical(1) Medicine Name: NF2 (NOQ19), Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Antarabhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -WATER), Additional Information: 2 TABLET TDS BF WITH WATER
2Comparator Arm (Non Ayurveda)-PLACEBO PLANT STARCH SAME COLOUR AND SIZE 2 TABLET OF 500 MG TDS BF WITH WATER
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Hospitalized or in home isolation adult patient aged >18 years
Confirmed COVID-19 infection (RT –PCR- Upper respiratory tract nasopharyngeal and oropharyngeal swab.
mild and moderate Symptomatic COVID 19 infection with or without comorbidities
Willingness to participate in the study
Indian nationals
 
 
ExclusionCriteria 
Details  Age less than 18 years
Pregnancy and Lactation
Moribund state in which death is perceived to be imminent (≤48 hours)
Patient not willing to participate in the study
Participation in any other clinical study
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
To evaluate the effect of NF2 in COVID 19 patients as time to become COV2 RT-PCR negative, duration of hospital stay, time to resolution of symptoms   7 days for each participant 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
Effect of NF2 therapy on laboratory parameters - CBC, CRP, LFT, KFT  Entry and Exit 
 
Target Sample Size
Modification(s)  		 Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/01/2022 
Date of Study Completion (India) 23/02/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
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   Not Applicable 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [dranurag23@gmail.com].

  6. For how long will this data be available start date provided 01-04-2022 and end date provided 11-04-2027?
    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 - NIL
Brief Summary
Modification(s)  		 The current pandemic of Covid-19 has shaken the entire world. In spite of various scientific researches and technological advancements exact treatment to cure the disease is yet to be discovered. Ayurvedic medicine NOQ 19 is a polyherbal formulation that has immunomodulating and immune enhancing properties. The present randomized, double blind, placebo controlled, multi-centric trial is planned to determine the therapeutic efficacy of Ayurvedic medicine NF2 (NOQ19)  in treatment of symptomatic COVID-19 patients along with standard allopathic treatment.  GIMS providing COVID-19 Care will be involved in conducting this trial.  Admitted positive patients admitted in the hospital in the age group 18-65 years will be recruited and randomized into treatment and control arm.  Following randomization 50 of them will be given Ayurvedic medicine NAOQ19 along with standard treatment and other 50 will receive placebo plus standard treatment. The follow up period will be for maximum of 7 days. Outcome measures that will be assessed are time to become SARS CoV2 RT PCR negative, reduction in symptoms and duration of hospital stay. Apart from this the blood samples will be collected at entry and exit to measure CBC, KFT, LFT, serum CRP 
Close