The effect of Ayurvedic intervention (Ayurveda Raksha Kit) as a preventive measure in the Pandemic of COVID-19 - A community based study

A prospective open label controlled interventional study on the effect of Ayurvedic intervention (Ayurveda Raksha Kit) as a prophylactic measure in the Pandemic of COVID-19 - A community based study

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/08/027316

Enrollment

200000

Registered

2020-08-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Ayurvrda Raksha Kit and advised to follow Standard preventive measures of COVID-19 (liquid soap/soaps for hand wash and mask/masks will be provided): The Ayurveda Raksha Kit will be pro

Eligibility

Inclusion criteria

Inclusion criteria: a) Participants residents of the identified SC dominated area/colony/village where at least 1 confirmed case is already identified b) Above the age of 18 years & above c) Participants who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study d) Willing to take study medication

Exclusion criteria

Exclusion criteria: e) Known cases of Covid-19. f) Pregnant and Lactating females g) Known cases of uncontrolled Diabetes and Hypertension h) Participants having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening i) Participants having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. j) Participants taking Steroid treatment and or any kind of immunosuppressive therapy k) Participants participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. l) Participants having a history of allergy to any medicine that is part of the Ayurvedic intervention.

Design outcomes

Primary

Measure	Time frame
Primary Outcome measures 1) Comparative assessment of occurrence of COVID-19 infection in Clinically stable participants in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic Care Timepoint: baseline, 15th day, 30th day, 45th day	—

Secondary

Measure	Time frame
Comparative assessment of severity of COVID-19 infection in participants taking Ayurvrda Raksha Kit and the control arm in following situations: Global assessment of overall change as per the investigator (Efficacy assessment) by using Immunity Status Questionnaire (ISQ); To observe the general well-being of people like appetite, bowel habit, sleep among the study population (assessed on VAS scale); Safety assessment by evaluation of occurrence of AE/SAETimepoint: baseline, 15th day, 30th day, 45th day	—

Measure

Time frame

Comparative assessment of severity of COVID-19 infection in participants taking Ayurvrda Raksha Kit and the control arm in following situations: Global assessment of overall change as per the investigator (Efficacy assessment) by using Immunity Status Questionnaire (ISQ); To observe the general well-being of people like appetite, bowel habit, sleep among the study population (assessed on VAS scale); Safety assessment by evaluation of occurrence of AE/SAETimepoint: baseline, 15th day, 30th day, 45th day

—

Countries

India

Contacts

Public ContactDr Sunita mata

Central Council for Research in Ayurvedic Sciences

sunita.dr@rediffmail.com

Outcome results