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CTRI Number  CTRI/2021/05/033543 [Registered on: 11/05/2021] Trial Registered Prospectively
Last Modified On: 21/09/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical trial of CIM-Meg19 in COVID-19 patients 
Scientific Title of Study   A study to assess efficacy and safety of Ayurvedic formulation [CIM-MEG19] as an add-on therapy to the standard care in mild to moderate COVID 19 positive to combat the severity / recovery of symptoms / disorders  
Trial Acronym  CSIR-CIMAP-CIM-MEG19 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Karuna Shanker 
Designation  Senior Principal Scientist 
Affiliation  CSIR-CIMAP, Lucknow 
Address  Phytochemistry Division CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknow

Lucknow
UTTAR PRADESH
226015
India 
Phone  9415329718  
Fax    
Email  k.shanker@cimap.res.in  
 
Details of Contact Person
Scientific Query  
Name  Prof Asmita Wele 
Designation  Professor & Head 
Affiliation  College of Ayurved, Bharati Vidyapeeth  
Address  Department of Rasa Shastra evum Bhaishaijya kalpana, Bharati Vidyapeeth (Deemed University)
Katraj Dhankwadi Educational Campus, Pune – Satara Road, Pune Maharashtra
Pune
MAHARASHTRA
411043
India 
Phone  09923356085  
Fax    
Email  asmita.wele@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Karuna Shanker 
Designation  Senior Principal Scientist 
Affiliation  CSIR-CIMAP, Lucknow 
Address  Phytochemistry Division, CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknowd, Pune

Lucknow
UTTAR PRADESH
226015
India 
Phone  9415329718  
Fax    
Email  k.shanker@cimap.res.in  
 
Source of Monetary or Material Support  
M/s Meghdoot Gramodyog Sewa Sansthan, A1/18, Sector H, Aliganj, Lucknow-226024, U.P. India 
 
Primary Sponsor  
Name  Ms Meghdoot Gramodyog Sewa Sansthan 
Address  M/s Meghdoot Gramodyog Sewa Sansthan A1/18, Sector H, Aliganj Lucknow, U.P.(India) - 226024 Phone: 9936017722, 9335634582 Email: mg.vimal@gmail.com 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Council of Scientific and Industrial Research CSIR  Anusandhan Bhawan, 2, Rafi Marg, Sansad Marg Area, New Delhi, Delhi 110001 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pranesh Gaikwad  Dr. D.Y. Patil College of Ayurved and Research Centre  Dr. D. Y. Patil Vidyapeeth, Pune, Pimpri, Pune-411 018
Pune
MAHARASHTRA 		 08149861142

pranesh.gaikad@dpu.edu.in 
Dr Pravin Soni  Yashwantrao Chavan Memorial Hospital, Pimpri, Pune  YCM Hospital Road, Sant Tukaram Nagar, Pimpri Colony, Pune - 411018
Pune
MAHARASHTRA 		 9822057511

drpravinsoni18@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC, PCMCs, PGI, Yashwantrao Chavan Memorial Hospital  Approved 
IEC- Dr.D.Y.Patil College of Ayurved and Research Centre  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: AGANTUJVARAH, (2) ICD-10 Condition:B972||Coronavirus as the cause of diseases classified elsewhere. Ayurveda Condition: SANNIPATA-JVAROPADRAVAH,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CIM-Meg19  02 tablets two times a day after meal to be administered orally. 
Comparator Agent  Standard care treatment  Standard care treatment as per site’s routine practice / physician’s opinion or as per current guidelines.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  COVID-19 RT-PCR positive patients
Male or Female of age 18-70 years
Subject is ready to give written Informed consent
Can take oral medicines
Mild to moderate grade of the disease. Mild- Upper respiratory tract symptoms of fever with or without shortness of breath or hypoxia. Moderate- Any one of- 1. Respiratory rate more than 24/min, breathlessness 2. SpO2: 90-93% on room air. 3. PaO2 /FiO2 : 200-300/g) as per AIIMS/ ICMR-COVID-19 National Task Force/Joint Monitoring Group recommendations
Not participating in any other interventional drug study g) Agree to follow all study procedures
 
 
ExclusionCriteria 
Details  Known sensitivity to the ingredients of IP
Bleeding haemorrhoids
Pre-existing GI symptoms like nausea or vomiting
Presence of acute hypoxic respiratory failure
Intensive care unit (ICU) stay-
Patients who need mechanical ventilation
Category 6 or 5 based on modified 7-category ordinal scale of clinical status
Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely Severe infection
Pregnant or lactating women
For Arm A: subjects receiving any antiviral treatment for Covid (like Favipiravir, Remdesivir)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A. To assess time to 2 point improvement (from time of enrolment) on the WHO ordinal scale  Days- 0, 4, 8 and 21 
 
Secondary Outcome  
Outcome  TimePoints 
Disease progression comparison in both arms
Frequency of serious adverse events in both the arms
Improvement in oxygen saturation
Proportion of RT-PCR negatives on Day 8 day
Number of hospital daysas compared to control group
Changes in lab investigations on day 4 daysWRT day 0(like inflammatory markers, haemogram etc.) in blood investigations group
 		 0, 8, 14 and 21 days 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   17/05/2021 
Date of Study Completion (India) 25/06/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Outcome of the study will be published in peer reviewed journal 
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 - 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 (Others) -  Research publication

  6. For how long will this data be available start date provided 05-12-2021 and end date provided 05-12-2022?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Study is an interventional, open label, double arm, randomized control trial to assess the safety and effectiveness of CIM-MEG19 compared to standard care medicines in adult patients of COVID-19. In this study eligible patients will be enrolled into 2 groups:  Group A or interventional group will receive CIM-MEG19 along with standard care(and those who are not advised Favipiravir and / or Remdesivirand / or any other antiviral drug for COVID management) and patients in Group B or control group will receive standard care alone (including antivirals). Considering lost-to-follow-ups, patients in each arm will be enrolled so as to achieve 28 complete follow-up patients.

The objectives of the study are as follows-

Primary objectives

  • To assess efficacy of CIM-MEG19 in Covid 19 patients in clinical improvement on WHO ordinal scale

Secondary Objectives

  • To assess efficacy of CIM-MEG19 in reducing inflammatory markers
  • To assess proportion of RT-PCR negatives on Day 8 (+ 3 days)
  • To assess Improvement in oxygen saturation 
  • To assess safety of CIM-MEG19 by AE/SAEs and LFT, RFT 

 
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