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CTRI Number  CTRI/2022/02/040088 [Registered on: 08/02/2022] Trial Registered Prospectively
Last Modified On: 21/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Impact of Ayuraksha Kit in prevention of Covid-19  
Scientific Title of Study   Impact of Ayuraksha Kit in Covid-19- Community Based Prophylactic Study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kalpana Kachare 
Designation  Research officer (Ayurveda) 
Affiliation  Central Council for Research in Ayurvedic Sciences, Ministry of Ayush  
Address  Central Council for Research in Ayurvedic Sciences Room No 121, First Floor, Janakpuri-110058
61-65 Institutional Area opposit to D block
South West
DELHI
110058
India 
Phone    
Fax    
Email  kachare.kalpana@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kalpana Kachare 
Designation  Research officer (Ayurveda) 
Affiliation  Central Council for Research in Ayurvedic Sciences, Ministry of Ayush  
Address  Central Council for Research in Ayurvedic Sciences, Room No 121, First Floor, Janakpuri-110058
61-65 Institutional Area opposit to D block
South West
DELHI
110058
India 
Phone    
Fax    
Email  kachare.kalpana@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Kalpana Kachare 
Designation  Research officer (Ayurveda) 
Affiliation  Central Council for Research in Ayurvedic Sciences, Ministry of Ayush  
Address  Central Council for Research in Ayurvedic Sciences, Room No. 121, First Floor, Janakpuri-110058
61-65 Institutional Area opposit to D block
South West
DELHI
110058
India 
Phone    
Fax    
Email  kachare.kalpana@gmail.com  
 
Source of Monetary or Material Support  
Central council for Research in Ayurvedic Sciences, New Delhi, 2nd Floor, 61-65, Institutional area, Opposite D block, Janakpuri 
 
Primary Sponsor  
Name  Ministry of Tribal Affairs 
Address  New Delhi 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrS Dodamani  Central Ayurveda Research Institute Bangalore  Central Ayurveda Research Institute Bangalore #12, Uttarahalli Manavarthe Kaval, Uttarahalli (Hobli), Bangalore South (Tq.) Kanakapura Main Road, Talaghattapura Post, Bengaluru - 560109 Telephone: 080-29535034(Office)/29635035(Hospital)
Bangalore
KARNATAKA 		 9448085818

shd_ayu@yahoo.co.in 
Dr Purnendu Panda  Central Ayurveda Research Institute Bhubaneshwar  Central Ayurveda Research Institute Bhubaneshwar Central Ayurveda Research Institute Bharatpur, Near Kalinga Studio, Bhubaneswar-751029, Dist- Khorda, Odisha.
Khordha
ORISSA 		 9777852889

pandapurnendu02@yahoo.com 
Dr Ekta dogra  Central Ayurveda Research Institute Guwahati  Central Ayurveda Research Institute Guwahati Borsojai, Beltola, Guwahati-781028. Phone No. 0361-2303714 Mobile No. 09435548209 Fax No. 0361-2303714
Kamrup
ASSAM 		 7696863979

dr.ektadogra@gmail.com 
DrRohit Ravate  Regional Ayurveda Research Centre Agartala  Regional Ayurveda Research Centre Agartala no-4, Ram Nagar Rd, Ram Nagar, Agartala, Tripura 799001 Phone: 0381 233 2007
West Tripura
TRIPURA 		 9007729430

rarc.agt-ccras@nic.in 
Dr Anil Avhad  Regional Ayurveda Research Institute Ahmadabad  Regional Ayurveda Research Institute Ahmadabad Block A & D, 2nd Floor, Bahumali Bhavan, Manjushree Mill Compound, Near Girdharnagar Over Bridge, Asarwa, Ahmedabad-380004 Phone : 079-22682155,
Ahmadabad
GUJARAT 		 9510176085

anilavhad4u@yahoo.com 
Dr P Srinivas  Regional Ayurveda Research Institute Chennai  Regional Ayurveda Research Institute Chennai 2nd Floor, VHS Campus, Taramani, Chennai, Tamilnadu. PIN: 600 113. E-mail : alrca-chennai@gov.in Office Phone : 044-22541536
Chennai
TAMIL NADU 		 9840879433

drsrinivaspitta@gmail.com 
DrAshok Sinha  Regional Ayurveda Research Institute Gangtok  Regional Ayurveda Research Institute Gangtok, THCRP Room Tadung, Gangtok, Sikkim-737102 Phone Number: 03592-231494 (Telefax)
South
SIKKIM 		 9466448410

drashoksinha22@gmail.com 
Dr Shyam Sing  Regional Ayurveda Research Institute Gwalior  Regional Ayurveda Research Institute Gwalior Govt. Ayurvedic Hospital, Amkho, Gwalior-474009 Phone No. 0751-2323307, 2432698 (direct) Fax. No. 0751-2430317
Gwalior
MADHYA PRADESH 		 9782560296

dr.shyam84@yahoo.in 
Dr VBKumawat  Regional Ayurveda Research Institute Jaipur  Regional Ayurveda Research Institute Jaipur Indira Colony, Bani Park, Jhotwara Road, Jaipur-302016. Phone: 0141-2281812 Fax: 0141-2282618
Jaipur
RAJASTHAN 		 8003514251

vinodbihari100@gmail.com 
DrVipin Sharma  Regional Ayurveda Research Institute Jammu  Regional Ayurveda Research Institute Jammu Rajinder Nagar,Ban Talab, Jammu-181123 Phone and Fax No. 0191-2546475,
Jammu
JAMMU & KASHMIR 		 9899437195

rariud.jammu@gmail.com 
Dr S Namburi  Regional Ayurveda Research Institute Nagpur  Regional Ayurveda Research Institute Nagpur Near Gharkul Parisar, Near Venkatesh Nagar, NIT Complex Nandanwan, Nagpur – 440009 (Maharashtra) Phone No. 0712-2714230
Nagpur
MAHARASHTRA 		 8055595355

shilpasekhar2k5@yahoo.com 
Dr Vimal Tiwari  Regional Ayurveda Research Institute Patna  Regional Ayurveda Research Institute Patna RMRI Building “D” Block, Agam Kuan, Patna-800007, Tele-fax:0612-2631678, Telephone:0612- 2630903
Patna
BIHAR 		 8176811914

vimalayuccras@gmail.com 
Dr K Nishanth  Regional Ayurveda Research Institute Vijayawada  Regional Ayurveda Research Institute Vijayawada New Rajiv Nagar, Payakapuram Vijayawada- 520015 Andhra Pradesh Phone: 0866 2402535
Krishna
ANDHRA PRADESH 		 9946307403

dr.nishanth.k@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 13  
Name of Committee  Approval Status 
Institutional Ethical committee of Central Ayurveda Research Institute Bangalore   Approved 
Institutional Ethical committee of Central Ayurveda Research Institute Bhuwaneshwar  Approved 
Institutional Ethical committee of Central Ayurveda Research Institute Guwahati  Approved 
Institutional Ethical committee of Central Ayurveda Research Institute Guwahati(Agartala)  Approved 
Institutional Ethical committee of Regional Ayurveda Research Institute Gangtok  Approved 
Institutional Ethical committee Reginol Ayurveda Research Institute Gwalior  Approved 
Institutional Ethical committee Reginol Ayurveda Research Institute Jaipur  Approved 
Institutional Ethical committee Reginol Ayurveda Research Institute Nagpur  Approved 
Institutional Ethical committee Reginol Ayurveda Research Institute Patana  Approved 
Institutional Ethical committee Reginol Ayurveda Research Institute Vijayawada  Approved 
Institutional Ethical committee Regional Ayurveda Research Institute Jammu  Approved 
Institutional Ethical committee Regional Ayurveda Research Institute Ahmadabad   Approved 
Institutional Ethical committee Regional Ayurveda Research Institute Chennai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Participants not having COVID-19 like symptoms, of age between 18 – 70 years, of any sex  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Standard preventive measures of COVID-19Instructions to follow Hand hygiene and respiratory etiquettes; use of Soap for hand wash, sanitizer and masks.
2Intervention ArmDrugClassical(1) Medicine Name: Chyavanprash , Reference: AFI, Part-I,3:11 pg.37,, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 6(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
(2) Medicine Name: Anu Taila, Reference: AFI, Part-I,8:1 Pg 128-129, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 10(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
(3) Medicine Name: Sanshamani Vati, Reference: AFI, Part-I,8:1 Pg 128-129, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(4) Medicine Name: 30 Days, Reference: Yes, Route: Water, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(5) Medicine Name: Ayush Kwath, Reference: Ministry of Ayush Guidelines -Ayurveda Preventive Measures for self-care during COVID-19 Pandemic, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 3(g), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: water), Additional Information: 3 gm boiled in 150 ml of water filtered and consume
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  a) Participants not having COVID-19 like symptoms, of age between 18 – 70 years, of any sex from the identified scheduled Tribe predominant areas/villages across India
b) Participants who are ready to provide informed consent.
 
 
ExclusionCriteria 
Details  i. Participants presenting with COVID-19 like symptoms
ii. Participants diagnosed as case of COVID-19 by positive RT-PCR test within one month prior to inclusion
iii. History of uncontrolled Diabetes mellitus or uncontrolled Hypertension
iv. Participants having any disease condition that would require immediate medical or surgical intervention
v. Known case of immune compromised state like HIV
vi. Known cases of COPD, Tuberculosis, Cancer, Hepatitis
vii. Participants on steroids or any immunosuppressive therapy
viii. Those who have participated in any other clinical trial within one month prior to screening
ix. Participants having a history of allergy to any medicine that is part of Ayuraksha Kit
x. Women who are Pregnant or are planning for pregnancy during the study period or those who are lactating mothers
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Comparison of proportion of participants developing COVID-19 like symptoms in both the groups during the study period. [Number of participants with fever, cough, or other respiratory/systemic symptoms (including but not limited to fatigue, myalgias, arthralgias, shortness of breath, sore throat, headache, chills, coryza, nausea, vomiting, diarrhoea)]  Time frame: baseline and at 30th day 
 
Secondary Outcome  
Outcome  TimePoints 
1. Comparison of the severity of Respiratory symptoms if developed in both the groups through Wisconsin Upper Respiratory Symptoms Survey (WURSS-24) questionnaire.

 		 Time frame: Daily- As soon as the participant reports of being symptomatic till they become asymptomatic or till 07 days whichever earlier. 

2. Comparison of the clinical outcome of the participants developing COVID-19 like symptoms in both the groups, during the study period as per WHO Clinical progression scale (10 point).
 		 Time frame: 15th and at 30th day 
3. Any change in psychological distress as an impact of exposure to COVID-19 among participants of both the groups assessed by using Kessler Psychological Distress Scale (K10).  Time frame: Baseline and at 30th day 
4. Percentage of drug compliance  Time frame: 15th and at 30th day 
5. Proportion of participants exhibiting Adverse Events of any grade at in both groups  Time frame: 15th day and at 30th day 
6. Occurrence of Treatment Emergent Adverse Events (TEAEs)  Time frame:15th day and at 30th day 
 
Target Sample Size   Total Sample Size="30800"
Sample Size from India="30800" 
Final Enrollment numbers achieved (Total)= "30800"
Final Enrollment numbers achieved (India)="30800" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   11/02/2022 
Date of Study Completion (India) 30/03/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

As on 4th January 2022, a total of 1892 cases of Omicron variant have been reported from 23 states (Top 5 being Maharashtra, Delhi, Kerala, Rajasthan, Gujarat) of India. In such situation, various measures, other than vaccination, to affect the immune system of the people positively also gain utmost importance to prevent the exhaustion of the overwhelmed health care system.

Interim reports of the community based prophylactic studies have revealed the safety and the prophylactic efficacy of the ayurvedic medicines and their combinations. One such prophylactic measure is Ayu Raksha Kit which is a combination of four formulations viz., Chyawanprash, Samshamani Vati, AnuTaila (for nasal instillation) and Ayush Kwath choorna (3 gm powder comprising Tulasi (Basil)-4 part, Dalchini (Cinnamon)-2 part, Shunthi (Dry Ginger)-2 Kalimirch (Black pepper)-1 part). The components of this kit indivisually are also studied for their prophylactic efficacy and safety against COVID-19. The dosage of the formulations in the kit can be as follows - Chyawanprash 6 gm OD; Ayush kwath 75 ml OD; Samshamani Vati 500mg BD and Anutaila one drop in each nostril BD for at least one month.

Herbal ingredients of Ayush Kwath such as Tulsi, Marich, Sunthi and Dalchini are commonly used and easily available drugs in home. On the basis of the experimental studies conducted on these ingredients, Ayush Kwath may collectively show immune-modulatory, antiviral, anti-oxidant, anti-inflammatory, antiplatelet,anti-atherosclerotic, hepato-protective, reno-protective properties and seems to be effective inimmuno-regulation for controlling viral infections like COVID-19. Pre-Clinical efficacy (immune modulatory) and safety (Regulatory Toxicology) evaluation of AYUSH Kwath was conducted by the National Institute of Nutrition. The interim results of an in-silico study being conducted IIT, Varanasi reveal that Beta-Sitosterol, a component of AYUSH Kwath, was found to be potential inhibitor of Mpro and RdRP of SARS-CoV-2.

            In view of this, the combination of these Ayurvedic formulations in the form of AyuRaksha Kit may be studied for its potential as a prophylactic measure to enhance the immunity and general well-being of the people.

 
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