Management of Flu with Herbal Medicine

Not Applicable

Completed

• Conditions: Health Condition 1: null- Influenza

• Registration Number: CTRI/2018/01/011387
• Lead Sponsor: Organic India

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-06-10
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

1. Subjects above the age of 18 years, providing written informed consent.

2. Patients with a duration of influenza symptoms confirmed by all of the following:

i. Fever >= 38º C (axillary) during the predose examinations or within the 4 hours prior if antipyretics were taken

ii. At least 1 each of the following general and respiratory symptoms associated with influenza is present with a severity of moderate or greater: a. General symptoms (headache, feverishness or chills, muscle or joint pain, or fatigue) b. Respiratory symptoms (cough, sore throat, or nasal congestion) Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours prior to first dose

3. The time interval between the onset of symptoms and the predose examinations is 48 hours or less. The onset of symptoms is defined as either:

a. Time of the first increase in body temperature (an increase of at least 1º C from normal body temperature)

b. Time when the patient experiences at least 1 new general or respiratory symptom

Exclusion Criteria

Patients will be considered at high risk of influenza complications due to the presence of at least 1 of the following inclusion criteria:

1. Asthma or chronic lung disease (such as chronic obstructive pulmonary disease or cystic fibrosis)

2. Endocrine disorders (including diabetes mellitus)

3. Residents of long-term care facilities (e.g., nursing homes)

4. Compromised immune system

5. Neurological and neurodevelopmental disorders

6. Heart disease (Congenital heart disease, Congestive heart failure)

7. Adults aged 65 years or more

8. Blood fisorders

9. Metabolic disorders

10. Morbid Obesity (BMI more than 40)

Other Any one of the following

1. Influenza vaccination with live attenuated vaccine in the 3 months prior to randomization

2. Antiviral treatment for influenza in 2 weeks prior to randomization

3. Severe Hepatic and renal impairment

4. Pregnant, attempting to conceive, or lactating women

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to improvement of symptoms: <br/ ><br>Time to improvement of symptoms is defined as the time from initiation of study treatment to improvement of influenza symptoms for a duration of at least 21.5 hours (24 hours - 10%).Timepoint: Day 1 pretreatment upto Day 7