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CTRI Number  CTRI/2020/07/026560 [Registered on: 14/07/2020] Trial Registered Prospectively
Last Modified On: 13/04/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Neem Prophylaxis for Subjects Coming in Contact with COVID-19 Patients 
Scientific Title of Study   Prophylaxis with Neem Capsules (Azadirachta indica) in Healthcare personnel and relatives in Contact with COVID-19 Patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CTP/NB/03/20, Version 1 dated 18 April 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Tanuja Manoj Nesari 
Designation  Director  
Affiliation  All India Institute of Ayurveda 
Address  All India Institute of Ayurveda, Mathura Road, Gautam Puri, New Delhi, Postal code: 110076, India

New Delhi
DELHI
110076
India 
Phone  91-11-269504  
Fax    
Email  director@aiia.gov.in  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohini Barde 
Designation  Medical Director  
Affiliation  Med Indite Communications Pvt Ltd 
Address  RH-05, PS Villa, Manjari, Pune-28

Pune
MAHARASHTRA
412307
India 
Phone    
Fax    
Email  drmohinib@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohini Barde 
Designation  Medical Director  
Affiliation  Med Indite Communications Pvt Ltd  
Address  RH-05, PS Villa, Manjari, Pune-28

Pune
MAHARASHTRA
412307
India 
Phone    
Fax    
Email  drmohinib@gmail.com  
 
Source of Monetary or Material Support  
Nisarga Biotech Pvt Ltd, 275- Chandan Nagar Addl. MIDC, Satara 415004, Maharashtra,India 
 
Primary Sponsor  
Name  Nisarga Biotech Pvt Ltd 
Address  275 Chandan Naga, Near Additional MIDC, Degaon Road, Satara. Maharashtra,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 Anju Bhardwaj  Department of AYUSH, ESIC Medical College and Hospital  ESIC Medical College and Hospital, New Industrial Township-3, NIT Faridabad.
Faridabad
HARYANA 
91-129-4156471

dr.annu1802@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee ESIC Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  At risk of Covid 19 (U07.1) 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Matching Placebo   Placebo capsule 50 mg twice a day for 28 days. 
Intervention  Neem capsule 50 mg   Neem capsule 50 mg twice a day for 28 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Subjects will be healthcare personnel (physicians, nurses, chemists, pharmacists, stretcher-bearer, administrative and respiratory therapists) who works in healthcare facility or other well characterized high-risk environment. OR Relative of a patient with COVID-19 infection in a participating hospital
2. Males and females of 18-60 years of age.
3. Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals.
4. Not previously diagnosed with COVID-19.
5. Not currently symptomatic with an Acute Respiratory Infection.
6. Women of childbearing potential and men who partner with a woman of childbearing potential must agree to use contraceptive methods.
7. Ability to swallow and retain oral medication.
8. Willingness and ability to comply with trial and follow-up procedures.
9. Ability to understand the nature of the trial and give written informed consent.
 
 
ExclusionCriteria 
Details  1. Known hypersensitivity to neem products.
2. Subjects on other prophylactic medications.
3. Age <18 years old.
4. Suspected or confirmed current COVID-19, defined as: temperature > 38 Celsius; cough; shortness of breath; sore throat; or, if available (not required), positive confirmatory testing for COVID-19.
5. Suspected or confirmed convalescent COVID-19, defined as any of the above symptoms within the prior 4 weeks.
6. Subjects who is on angiotensin-converting enzyme (ACE) inhibitor.
7. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.
8. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Number of symptomatic cases of COVID-19 infection  Within 56 days 
 
Secondary Outcome  
Outcome  TimePoints 
Number of asymptomatic cases of COVID-19 infection.   Baseline, Day 28 and Day 56  
Number of subjects reporting negative COVID-19 test (2019-nCoV RT-PCR).  Baseline, Day 28 and Day 56  
Rate of severe respiratory COVID-19 infection in symptomatic subjects.
 
Within 56 days 
Adverse events of Neem capsule  Within 56 days 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "190"
Final Enrollment numbers achieved (India)="190" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   21/07/2020 
Date of Study Completion (India) 09/12/2020 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Azadirachta indica has been reported to exert anti-inflammatory, antiviral and antioxidant effects.

 

This randomized, double blind, placebo -controlled study has been undertaken to evaluate the efficacy of Neem when given as prophylaxis. This study will be conducted in health care settings where the subjects will be healthcare personnel like physicians, nurses, chemists, pharmacists, stretcher-bearer, administrative and respiratory therapists who works in healthcare facility or other well characterized high-risk environment OR Relative of a patient with COVID-19 infection in a participating hospital. After obtaining informed consent, the investigator will recruit healthcare workers, or other individuals at significant risk who can be followed reliably for 56 days.


Total 190 subjects were enrolled in the study.

 
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