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CTRI Number  CTRI/2020/09/027974 [Registered on: 22/09/2020] Trial Registered Prospectively
Last Modified On: 21/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical Evaluation of Chyawanprash for the prevention of COVID-19 among Health Care Personnel . 
Scientific Title of Study
Modification(s)  
Clinical Evaluation of Chyawanprash for the prevention of COVID-19 among Health Care Personnel – An open label, prospective Randomized controlled study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Satyendra Kumar Sonkar 
Designation  Professor(Jr Grade) 
Affiliation  KGMU ,Lucknow 
Address  Department of Medicine, KING GEORGES MEDICAL UNIVERSITY, Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003

Lucknow
UTTAR PRADESH
226003
India 
Phone  9307288648  
Fax    
Email  drsksinghraried@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Satyendra Kumar Sonkar 
Designation  Professor(Jr Grade) 
Affiliation  KGMU ,Lucknow 
Address  Department of Medicine, KING GEORGES MEDICAL UNIVERSITY, Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003

Lucknow
UTTAR PRADESH
226003
India 
Phone  9307288648  
Fax    
Email  satyendra.sonkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Satyendra Kumar Sonkar 
Designation  Professor(Jr Grade) 
Affiliation  KGMU ,Lucknow 
Address  Department of Medicine, KING GEORGES MEDICAL UNIVERSITY, Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003

Lucknow
UTTAR PRADESH
226003
India 
Phone  9307288648  
Fax    
Email  satyendra.sonkar@gmail.com  
 
Source of Monetary or Material Support  
CCRAS New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Ayurvedic Sciences CCRAS 
Address  Jawahar Lal Nehru BhartiyaChikitsaEvam Homoeopathy AnusandhanBhawan 61-65, Institutional Area, Opposite D-Block, Janakpuri New Delhi-110058  
Type of Sponsor  Government funding agency 
 
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 Satyendra Kumar Sonkar  KING GEORGES MEDICAL UNIVERSITY LUCKNOW  Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003
Lucknow
UTTAR PRADESH 
9307288648

satyendra.sonkar@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King Georges Medical University U.P. Institutional Ethics Committee Lucknow226003  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Negative for SARS- Cov-2  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard care as per the Ministry of heath and family welfare guidelines for COVID19 and Updated   Standard Preventive Regimen for healthcare workers(Standard precaution, Hand hygiene, Personal protective equipment , Respiratory hygiene and cough etiquette.)  
Intervention  Standard Preventive Regimen plus Ayurveda Rasayana (Chyawanprash)   Standard Preventive Regimen for healthcare workers(Standard precaution, Hand hygiene, Personal protective equipment , Respiratory hygiene and cough etiquette.) and Chyawanprash, Dose, 12gm twice daily Ayurvedic Formulation will be assessed in separate drug trial studies with a randomized two arm parallel design as per protocol.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All healthcare professionals and staff of age group between 25 to 60 years willing to participate, negative for SARS- Cov-2 at screening,(tested by rt-PCR), at KGMU , without co-morbid condition with exposure/chance of exposure to COVID 19 positive cases.
Who are willing to provide signed informed consent.
High Risk Group- It includes doctors, nursing staff and other paramedical staff like attendant who are directly looking after and examining COVID patients.
Low risk- other faculty members who are present in the institute but not visiting corona ward.
 
 
ExclusionCriteria 
Details  Pregnant and lactating females.
Immune compromised and co morbid condition cases.
Laboratory confirmed COVID-19 with or without symptoms
Known allergy to any of the medications used in this trial.
Not willing to participate in the study.
Subjects who are taking any other medicine as prophylaxis such as HCQ.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Percentage of participants with SARS- Cov-2 positivity as estimated by RT-PCR of nasopharyngeal swab / Chemiluminiscence assay after 1 month of consuming Chyawanprash.  Baseline, 7th day,15th day,and 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
Safety profile of the intervention as estimated by LFT, KFT and other haematological & biochemical investigations.
Presence or absence of AE/ADR.
Number of participants who developed any infective diseases during the trial period (bacterial /viral/ fungal / etc.) and percentage of participants with Upper respiratory tract illness during the period.
Immune and inflammatory markers (IgG, IgM, IgE, Hs-CRP TNF - α,IL6, IL10) baseline and end of treatment.
 
Baseline ,on 7th day,on 15th day,and completion of study 30th day. 
 
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   Phase 2 
Date of First Enrollment (India)   15/10/2020 
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="0"
Months="4"
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)?  

Response - NO
Brief Summary  

COVID-19 has emerged as the latest pandemic that erupted in the Wuhan City of People’s Republic of China in December 2019, which is affecting human health and economy across the world. 1 133758 cases has been reported globally as on April 5, according to the WHO Coronavirus disease 2019 (COVID-19) Situation Report – 76. The occurrence of the ongoing COVID-19 in developed countries also highlights the fact that developed countries and rich populations are not immune to the outbreaks of infectious diseases. Coronaviruses (CoVs) belong to the family Coronaviridae and are enveloped, single-stranded, positive-sense RNA viruses. The SARS-CoV-2 belongs to the beta CoV genus which also includes the SARS-CoV-1 and the MERS-CoV. The lack of approved effective drug therapeutic protocols for CoVs would be a challenge for the treatment of the newly emerged COVID-19 infections worldwide. Drug repurposing, which is defined as identifying alternative uses for approved or investigational drugs outside their defined indication, could be a possible way to overcome the time limitation of research and development needed to design a therapeutic drug to combat the pathogen. The drug repurposing or repositioning approach thus can facilitate prompt clinical decisions at lower costs than de novo drug development.1 Though drug repurposing is sometimes based on chance observations, target-based repurposing of drugs depends on prior understanding of the precise molecular or cellular element that is recognized by the proposed drug,2,3 Ayurveda and traditional systems of Medicine in India have been treating diseases of infectious and non-infectious origin equally with expansive success rates, treating the patients through an individualized person to person approach depending upon the presentation of clinical symptoms in each.

 

Chyawanprash is a 5000 year old Ayurvedic multi-herbal jam considered to be a Rasayana for all the tissues of the body. Rasayana translates to “path of essence” as it promotes systemic rejuvenation of the mind and body.  Chyawanprash is a potent antioxidant paste, prepared through the synergistic blending of around 50 herbs and spices. Chyawanprash falls, by virtue of its consistency and form of dosage, under the category of Awaleha (electuaries/herbal jams), a group of Ayurvedic formulations.4

 

 

Respiratory Health- Protect and Strengthens the Respiratory System

A regular intake of Chyawanprash strengthens the trachea–bronchial tree and hence improves the immunity and functioning of the respiratory system. It helps to treat respiratory infections, allergic cough, asthma, bronchospasm, rhinitis, seasonal or non seasonal respiratory disorders, common cold, and tuberculosis, and thus strengthens the respiratory system. It is also used as an adjunct to antitubercular drugs to augment their bioactivity and prevent their side effects5-7 In a randomized controlled trial (RCT), 90 pulmonary tuberculosis patients were treated with Chyawanprash 10 g, twice daily as an adjunct to antitubercular drugs. Chyawanprash augmented the bioactivity of antitubercular drugs and prevented their side effects. Cough, expectoration, weakness, loss of appetite, loss of weight, fever, edema aches, and hemoptysis disappeared almost completely in the treated group, along with improvement in the hemoglobin (Hb) levels and effective healing as evidenced through chest X-ray post-therapy.5,8 Another observational study on 99 newly diagnosed pulmonary tuberculosis patients revealed that concomitant adjunct use of CP with antitubercular drugs significantly abated the symptoms and improved bioavailability of isoniazid and pyrazinamide.7

 

Antioxidant, Adaptogenic, and Immune-Booster

Recent investigations have ascertained that polyphenols (gallic acid, catechin, epicatechin) in CP exert key antioxidant potential and is known to possess potent neuroprotective, cytoprotective, and antioxidant properties.9,10 Chyawanprash is an effective adaptogenic.11 Some clinical reports do support the adaptogenic and antioxidant effect of Chyawanprash on normal and depressive subjects.12 Due to the rich Amla percentage, Chyawanprash is loaded in high vitamin C, polyphenolics, including flavonoids, and exhibits evident antioxidant and free radical scavenging activity, enhances the immune system, and fights infections.13 In a 6-month-long randomized, open labelled, prospective, multicenter, clinical study in children (5–12 years), CP was shown to lead to significant improvement in immunity, energy levels, physical strength, vigor, and quality of life assessed through KIDSCREEN QOL-27 questionnaires in children.14 Clinical studies support the immune-booster role of Chyawanprash as demonstrated by reduced disease symptoms of seasonal influences, modulated IgE and immunity markers C3 and C4 levels, improved pulmonary functions, decreased cortisol levels, and increased quality of life (QoL).15

The minute quantities of spice components of Chyawanprash are also known for their wide range of health benefits by their antioxidative, chemopreventive, antimutagenic, anti-inflammatory, immune-modulatory effects on cells and several beneficial effects on the gastrointestinal, cardiovascular, respiratory, metabolic, reproductive, neural, and other systems.16

 

Chyawanprash: A Nutraceutical and Functional Food

Chyawanprash has been a consistent part of Indian tradition both as a functional food and nutraceutical for the past 5000 years, with constant zeal and vivacity, and has survived owing to its peerless health benefits. Chyawanprash is reported to have rich vitamin, protein, dietary fiber, energy contents, carbohydrate, low fat contents (no-trans and zero percent cholesterol), and appreciable levels of major and minor trace elements (mg/100g), such as Fe (21.1), Zn (3.1), Co (3.7), Cu (0.667), Ni (1.4), Pb (2.4),Mn (8.3), vitamin C (0.5), tannic acid (20.2), other vitamins A, E, B1, B2, and carotenoids that act as micronutrients for health-invigorating purposes. It also provides several essential phytoconstituents, namely, flavonoids, alkaloids, saponins, antioxidants, piperine, phenolic compounds, etc. The synergistic antioxidant effects of vitamin C along with vitamin E and carotenoids are well known. The rich nutritive composition and antioxidant biomolecules of CP act both singly as well as synergistically for immuno-modulation, body building, health restoration, and prevention of oxidative damage (a leading cause of several degenerative diseases)  
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