CTRI/2022/02/040156 [Registered on: 10/02/2022] Trial Registered Prospectively
Last Modified On:
09/02/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Ayurveda Preventive
Study Design
Cluster Randomized Trial
Public Title of Study
Impact of Ayuraksha Kit in COVID-19
Scientific Title of Study
A prophylactic community based study to assess the impact of Ayuraksha Kit in COVID-19
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
Nil
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Sunita Mata
Designation
Research Officer
Affiliation
Central Council for research in Ayurvedic sciences
Address
Room No. 121 61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058
South West DELHI 110058 India
Phone
8010529320
Fax
Email
sunita.dr@rediffmail.com
Details of Contact Person Scientific Query
Name
Dr Sunita Mata
Designation
Research Officer
Affiliation
Central Council for research in Ayurvedic sciences
Address
Room No. 121 61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058
South West DELHI 110058 India
Phone
8010529320
Fax
Email
sunita.dr@rediffmail.com
Details of Contact Person Public Query
Name
Dr Sunita Mata
Designation
Research Officer
Affiliation
Central Council for research in Ayurvedic sciences
Address
Room No. 121 61-65, opp. D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058
South West DELHI 110058 India
Phone
8010529320
Fax
Email
sunita.dr@rediffmail.com
Source of Monetary or Material Support
Central council for research in Ayurvedic science
Primary Sponsor
Name
Central council for research in Ayurvedic Sciences
Address
61-65, opp. D Block, Janakpuri Institutional Area Janakpuri New Delhi Delhi 110058
Type of Sponsor
Research institution
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 12
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Asha S
ARARI Chennai
SCSP Room,Regional Ayurveda Research Institute Chennai 2nd Floor, VHS Campus, Taramani, Chennai, Tamilnadu. PIN: 600 113 Chennai TAMIL NADU
9895192067
dr.ashas2324@gmail.com
Dr Tejaswini
CARI Bangalore
SCSP Room Central Ayurveda Research Institute Bangalore #12, Uttarahalli Manavarthe Kaval, Uttarahalli (Hobli), Bangalore South (Tq.) Kanakapura Main Road, Talaghattapura Post, Bengaluru - 560109 Bangalore KARNATAKA
9738222525
theju.tani99@gmail.com
Dr Indu
CARI Bhubaneswar
SCSP Room Central Ayurveda Research Institute Bhubaneshwar Central Ayurveda Research Institute Bharatpur, Near Kalinga Studio, Bhubaneswar-751029 Khordha ORISSA
9995348359
indusabu87@gmail.com
Dr P L Bharti
CARI Guwahati
SCSP Room Central Ayurveda Research Institute Guwahati Borsojai, Beltola, Guwahati- 781028 Kamrup ASSAM
9407587686
plbharati@rediffmail.com
Dr Laxman Bhurke
CARI Mumbai
SCSP Room Raja Ramdeo Anandilal Podar Central Ayurveda Research Institute (under CCRAS, Ministry of AYUSH, Government of India)
Podar Medical Campus, Dr. Annie Besant Road, Worli, Mumbai-400018, Maharashtra, India Mumbai MAHARASHTRA
9086087677
dewa2007@rediffmail.com
Dr Seema Jain
CARI New Delhi
SCSP Room
Road No.66, Punjabi Bagh(West)
New Delhi – 110 026 West DELHI
8851677673
dr_seema_jain@yahoo.co.in
Dr ParvathyDev
NARIP Cheruthuruthy
SCSP Room National Ayurveda Research Institute for Panchakarma, Cheruthuruthy, Thrissur District, Kerala-679531, (India) Thrissur KERALA
9745886253
parvathy2333@gmail.com
Dr Parth Dave
RARI Ahmadabad
SCSP Room Regional Ayurveda Research Institute Ahmadabad Block A & D, 2nd Floor, Bahumali Bhavan, Manjushree Mill Compound, Near Girdharnagar Over Bridge, Asarwa, Ahmedabad-380004 Ahmadabad GUJARAT
8779313377
drppdave88@gmail.com
Dr Sashi Kant Vedi
RARI Jaipur
SCSP Room
M.S. Regional Ayurveda Research Institute (RARI),
Indira Colony, Bani Park, Jhotwara Road, Jaipur-302016 Jaipur RAJASTHAN
9958426086
drskvedi@gmail.com
Dr U R Shankar
RARI Nagpur
SCSP Room Regional Ayurveda Research Institute Nagpur Near Gharkul Parisar, Near Venkatesh Nagar, NIT Complex Nandanwan, Nagpur – 440009 Nagpur MAHARASHTRA
8055595355
shilpasekhar2k5@yahoo.com
Dr Sinimol TP
RARI Trivandrum
SCSP Room Regional Ayurveda Research Institute
Poojappura, Thiruvananthapuram Kerala-695012 Thiruvananthapuram KERALA
9446519427
drsinitp@gmail.com
Dr AJV Sai Prasad
RARI Vijayawada
SCSP Room Regional Ayurveda Research Institute
New Rajiv Nagar, Payakapuram
Vijayawada- 520015 Krishna ANDHRA PRADESH
9490716761
saiprasad_avvaru@yahoo.co.in
Details of Ethics Committee
No of Ethics Committees= 12
Name of Committee
Approval Status
Institutional ethical committee ARARI Chennai
Approved
Institutional ethical committee CARI Bangalore
Approved
Institutional Ethical Committee CARI, Guwahati
Approved
Institutional Ethical Committee CARI, Mumbai
Approved
Institutional Ethical Committee CARI, New Delhi
Approved
Institutional Ethical Committee Central Ayurvedic Research Institute, Bhubaneshwar
Participants not having COVID-19 like symptoms, of age between 18 – 70 years, of any sex
Intervention / Comparator Agent
sno
Intervention/Comparator
Type
Drug-Type
Procedure Name
Details
1
Comparator Arm (Non Ayurveda)
-
Standard preventive measures for COVID-19
Instructions to follow Hand hygiene and respiratory etiquettes; Soap for hand wash and masks will be provided to all the participants
2
Intervention Arm
Drug
Classical
(1) Medicine Name: Chyawanprash , Reference: A.F.I. 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: No, Additional Information: -(2) Medicine Name: Samshamani Vati , Reference: A.F.I. Part-II, 10:13 Pg. 183 , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Normal water), Additional Information: -(3) Medicine Name: Anu Taila , Reference: A.F.I. Part-I, 8:1 Pg. 128-129, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: two drops in each nostril(4) Medicine Name: Ayush kwath , Reference: Ayurveda Preventive Measures for self-care during COVID-19 Pandemic By Ministry of Ayush, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 75(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: 3 gm
Inclusion Criteria
Age From
18.00 Year(s)
Age To
70.00 Year(s)
Gender
Both
Details
i. Participants not having COVID-19 like symptoms, of age between 18 – 70 years, of any sex from the identified scheduled castes predominant areas/villages across India
ii. Participants who are ready to provide informed consent.
iii. Participants who have been either vaccinated or not vaccinated shall be included in the study.
iv. Participants who have been taking any other prophylactic medicine other than Ayu Raksha kit for COVID -19 shall also be included. The details will be noted and data will be analysed accordingly
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 Ayu Raksha Kit
x. Women who are Pregnant or are planning for pregnancy during the study period or those who are lactating mothers
xi. The asymptomatic RT-PCR confirmed COVID-19 cases at the time of screening shall be excluded.
Method of Generating Random Sequence
Computer generated randomization
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)]
Baseline and 30 days
Secondary Outcome
Outcome
TimePoints
1) Incidence of Real time Reverse Transcription Polymerase Chain Reaction confirmed cases in the subset of population.
at the time of screening and as and when participants report incidence of symptoms or at 30th day if they remain asymptomatic through-out the study period
2) Any change in CBC (Hemoglobin, RBC count, TLC, DLC, Platelet count and Hematocrit), LFT (AST, ALT, ALP, Serum Bilirubin, Serum Albumin and Serum Globulin) and RFT (Serum Creatinine, Blood Urea, Serum Uric Acid, eGFR)
At Screening and at 30th day
3) Comparison of the severity of Respiratory symptoms if developed in both the groups through Wisconsin Upper Respiratory Symptoms Survey (WURSS-24) questionnaire.
Daily- As soon as the participant reports of being symptomatic till they become asymptomatic or till 07 days whichever earlier
4) 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).
At Screening and at 30th day
5) 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).
At Screening and at 30th day
6)Percentage of drug compliance
At 15th and 30th day
7)Proportion of participants exhibiting Adverse Events of any grade.
At 15th and 30th day and As soon as the participant reports
8)Occurrence of Treatment Emergent Adverse Events (TEAEs)
At 15th and 30th day and As soon as the participant reports
Target Sample Size
Total Sample Size="8316" Sample Size from India="8316" 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 3
Date of First Enrollment (India)
10/02/2022
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="2" Days="0"
Recruitment Status of Trial (Global)
Not Yet Recruiting
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
This is
a multi centric cluster randomized control clinical trial which will be
carried out at 12 peripheral institutes of CCRAS. In intervention group
Ayuraksah Kit will be given along with Instructions to follow Hand hygiene
and respiratory etiquettes; Soap for hand wash and masks will be
provided to all the participants. In control group with Instructions to
follow Hand hygiene and respiratory etiquettes; Soap for hand wash and
masks will be provided to the participants. Total 8316 participants will be
enrolled in the study.
Apparently
healthy participants from the randomly selected clusters will be asked for
providing their consent electronically or in writing regarding their
participation in the study. Participants will be recruited in the study based
on the defined inclusion and exclusion criteria of the study. Participant
allocation in either study groups shall be based on cluster randomization
schedule.
Demographic
data and other details of the enrolled participants will be recorded at the
baseline in the E-CRF. All the participants will be instructed to inform about
any Adverse Event if happens during the study period. The participants will be
instructed to immediately inform the investigator if they develop any signs and
symptoms compatible to COVID-19.All participants will be followed up telephonically
at 15th day and 30th day and the data will be collected in the case record form.
Out of
12 study centers, 4 centers will be assigned to conduct incidence of RT-PCR
confirmed COVID-19.