Impact of Ayuraksha Kit in COVID-19

Phase 3

Not yet recruiting

Conditions: Participants not having COVID-19 like symptoms, of age between 18 â€“ 70 years, of any sex

Registration Number: CTRI/2022/02/040156

Lead Sponsor: Central council for research in Ayurvedic Sciences

Brief Summary: This isa multi centric cluster randomized control clinical trial which will becarried out at 12 peripheral institutes of CCRAS. In intervention groupAyuraksah Kit will be given along with Instructions to follow Hand hygieneand respiratory etiquettes; Soap for hand wash and masks will beprovided to all the participants. In control group with Instructions tofollow Hand hygiene and respiratory etiquettes; Soap for hand wash andmasks will be provided to the participants. Total 8316 participants will beenrolled in the study.

Apparentlyhealthy participants from the randomly selected clusters will be asked forproviding their consent electronically or in writing regarding theirparticipation in the study. Participants will be recruited in the study basedon the defined inclusion and exclusion criteria of the study. Participantallocation in either study groups shall be based on cluster randomizationschedule.

Demographicdata and other details of the enrolled participants will be recorded at thebaseline in the E-CRF. All the participants will be instructed to inform aboutany Adverse Event if happens during the study period. The participants will beinstructed to immediately inform the investigator if they develop any signs andsymptoms compatible to COVID-19.All participants will be followed up telephonicallyat 15th day and 30th day and the data will be collected in the case record form.

Out of12 study centers, 4 centers will be assigned to conduct incidence of RT-PCRconfirmed COVID-19.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 8316

Inclusion Criteria

i.Participants not having COVID-19 like symptoms, of age between 18 â€“ 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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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
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
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
7)Proportion of participants exhibiting Adverse Events of any grade.	At 15th and 30th day and As soon as the participant reports
6)Percentage of drug compliance	At 15th and 30th day
8)Occurrence of Treatment Emergent Adverse Events (TEAEs)	At 15th and 30th day and As soon as the participant reports

Trial Locations

Locations (12): ARARI Chennai
🇮🇳
Chennai, TAMIL NADU, India
CARI Bangalore
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Bangalore, KARNATAKA, India
CARI Bhubaneswar
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Khordha, ORISSA, India
CARI Guwahati
🇮🇳
Kamrup, ASSAM, India
CARI Mumbai
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Mumbai, MAHARASHTRA, India
CARI New Delhi
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West, DELHI, India
NARIP Cheruthuruthy
🇮🇳
Thrissur, KERALA, India
RARI Ahmadabad
🇮🇳
Ahmadabad, GUJARAT, India
RARI Jaipur
🇮🇳
Jaipur, RAJASTHAN, India
RARI Nagpur
🇮🇳
Nagpur, MAHARASHTRA, India
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ARARI Chennai
🇮🇳Chennai, TAMIL NADU, India
Dr Asha S
Principal investigator
9895192067
dr.ashas2324@gmail.com