Clinical trial NCT04621903: A Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19
Official title: A Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19: Community Based Participatory Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Keywords: Ayurveda
Shanshamani Vati Plus
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
Collaborators: name: University of Warwick
name: All India Institute of Ayurveda, Ministry of AYUSH, Government of India
First posted: 2020-11-09
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The COVID-19 pandemic is considered as the most crucial global health concern of the century. Given the complex interaction of physical and social factors on fast spreading infection, there have been increasing calls for comprehensive efforts using a community-based participatory research (CBPR) approach.

CBPR partnership composed of representatives from community-based organisations, health and academia actively developed the present study. Specific aims were (1) to assess the efficacy and safety of Ayurvedic combination, Giloy (Tinospora Cordifolia) and Pippali (Piper longum) in the management of mild-to-moderate cases of COVID-19 and (2) to determine the effect in relieving COVID-19 symptoms and preventing the onset of severe infection.


Eligibility criteria: Inclusion Criteria:

* With SARS-CoV-2 infection confirmed through reverse transcription followed by polymerase chain reaction (RT- PCR),
* With mild or moderate manifestations of COVID-19
* Willing to participate, and consent by signing the informed consent and not involved in another clinical trial during the study period

Exclusion Criteria:

* Patients suffering from severe COVID-19 Disease as judged by WHO criteria (REF)
* Any of the known COVID-19 complications and emergency procedures which may require shift/admission in hospital for oxygen support or intensive care unit
* Patients with ongoing immunosuppressive therapy for any reasons for example solid organ transplantation, autoimmune diseases or cancer.
* Patients with known long term infection like HIV
* Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy.
* Pregnancy and lactation
* Ayurveda practitioner decision that involvement in the study is not in the patient's best interest

Primary outcomes:
measure: Time to COVID-19 symptoms relief
timeFrame: Up to 14-days
measure: Prevention of severe stage of Covid19
timeFrame: Up to 14-days
Secondary outcomes:
measure: Side effect/ adverse events
timeFrame: Up to 14-days
measure: COVID-19 severity worsening
timeFrame: Up to 14-days
measure: Time to negative saliva
timeFrame: Up to 14-days
Other outcomes:
Locations:
city: Leicester
country: United Kingdom
facility: Aarogyam (UK) CIC
Study officials:
affiliation: University of Warwick
name: Vishwesh Kulkarni
role: PRINCIPAL_INVESTIGATOR
affiliation: Aarogyam UK
name: Neha Sharma
role: STUDY_DIRECTOR
affiliation: East Park Medical Centre, Leicester NHS Trust
name: Dipa Modi
role: STUDY_CHAIR
affiliation: All India Institute of Ayurveda, Ministry of AYUSH, Government of India
name: Tanuja Nesari
role: PRINCIPAL_INVESTIGATOR
References: