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A Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19

NCT ID: NCT04621903

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2020-11-03

Brief Summary

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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.

Detailed Description

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Conditions

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Covid19

Keywords

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Ayurveda Shanshamani Vati Plus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Ayurveda

Group Type EXPERIMENTAL

Shanshamani Vati Plus

Intervention Type OTHER

Shanshamani Vati Plus was given as combination of Guduchi (Tinospora Cordifolia; 300 mg) and Pipli (Piper Longum 75 mg) twice daily.

Interventions

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Shanshamani Vati Plus

Shanshamani Vati Plus was given as combination of Guduchi (Tinospora Cordifolia; 300 mg) and Pipli (Piper Longum 75 mg) twice daily.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Warwick

OTHER

Sponsor Role collaborator

All India Institute of Ayurveda, Ministry of AYUSH, Government of India

UNKNOWN

Sponsor Role collaborator

Aarogyam UK

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vishwesh Kulkarni

Role: PRINCIPAL_INVESTIGATOR

University of Warwick

Neha Sharma

Role: STUDY_DIRECTOR

Aarogyam UK

Dipa Modi

Role: STUDY_CHAIR

East Park Medical Centre, Leicester NHS Trust

Tanuja Nesari

Role: PRINCIPAL_INVESTIGATOR

All India Institute of Ayurveda, Ministry of AYUSH, Government of India

Locations

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Aarogyam (UK) CIC

Leicester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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AU/WU/ 06

Identifier Type: -

Identifier Source: org_study_id