Ayurveda for Flu Like Illness During Covid-19 Outbreak

NCT04351542 | Completed

• 1 other identifier: AU09
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study aimed to evaluate the efficacy and safety of Ayurveda in reducing symptoms of flu like illness during the Covid 19 outbreak.

Conditions

Flu Like Illness

Outcome Measures

Primary Outcomes (2)

• Time to achieve afebrile

  Time to bring down a fever (oral temperature \< 37.2 ̊C)

  Change from baseline to 3rd and 7th-day

• Severity of symptom score

  Symptoms diary card completed twice daily from Day 0 to Day 7

  Change from baseline to 3rd and 7th day

Secondary Outcomes (1)

• Patient reported improvement

  Change from baseline to 3rd and 7th-day

Study Arms (2)

Ayurveda Care Group

EXPERIMENTAL

Individualised ayurveda treatment was given to participants based on individual constitution.

Dietary Supplement: Ayurveda; Other: Usual Care

Usual Care Group

ACTIVE COMPARATOR

Participants followed the usual care.

Other: Usual Care

Interventions

Ayurveda DIETARY_SUPPLEMENT

Based on individual constitution (ayurveda based assessment) and symptoms an individual has, ayurveda herbal supplement and self managed practices were advised along with usual care recommendation.

Ayurveda Care Group

Usual Care OTHER

Usual care recommended by National Health Services, self isolation, plenty fluid, rest and Paracetamol. During the Covid 19 outbreak, additional recommendation were followed given by health services.

Ayurveda Care Group; Usual Care Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with fu like symptoms within 48 hours of onset during March2020
• Mild to moderate symptoms who were advised to self isolate at home for 7-14 days
• Flu like symptoms present at least one respiratory symptom (e.g. cough, nasal obstruction, sore throat) and at least one constitutional symptom other than fever (e.g. fatigue, headache, myalgias) of less than 48-hour duration
• Willing to consent and follow up

You may not qualify if:

• Pregnant/lactating
• Participants with chronic pulmonary diseases or critical condition or already developed severe respiratory distress
• Clinically malignancies, systemic infection, other medical or psychiatric condition which places the subject at unacceptable risk to participate in the study - Known hypersensitivity to any ayurveda herbal substances
• Severe symptoms of respiratory distress patients deemed to require intensive care immediately

Sponsors & Collaborators

• Aarogyam UK: lead

Study Sites (1)

Aarogyam

Leicester, United Kingdom

Location

MeSH Terms

Interventions

Medicine, Ayurvedic

Intervention Hierarchy (Ancestors)

Medicine, Traditional; Complementary Therapies; Therapeutics

Study Officials

• Neha Sharma, PhD

  Aarogyam UK

  PRINCIPAL INVESTIGATOR

• Jaydeep Joshi, BAMS

  Aarogyam UK

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Ayurveda care provide was blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 17, 2020
• Study Start: March 6, 2020
• Primary Completion: April 6, 2020
• Study Completion: April 12, 2020
• Last Updated: April 17, 2020

Record last verified: 2020-04

Locations

GB (1)