Clinical trial NCT03365336: Influenza Management With Polyherbal Formulation
Official title: Indian Herbal Medicine for Influenza - Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Influenza
Lead sponsor: Composite Interceptive Med Science
Sponsor class: INDUSTRY
First posted: 2017-12-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel follow up of two groups randomly allocated through a central randomization process.
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the efficacy of Flu care polyherbal formulation in the management of acute uncomplicated case of Influenza within 48 hours of symptoms onset.

Detailed description: Influenza is one of the most common epidemics occurring in India during winter months. Most of the commonly used antiviral have limited efficacy and safety in influenza treatment. Flu Care polyherbal consist of antiviral, antitussive and anti-inflammatory herbal medicine. If this Flu care intervention is shown to be effective, there will be major potential benefits to general population.

Eligibility criteria: Inclusion Criteria:

* Subjects above the age of 18 years, providing written informed consent.
* Patients with a duration of influenza symptoms confirmed by all of the following:

  1. Fever ≥ 38º C (axillary) during the predose examinations or within the 4 hours prior if antipyretics were taken
  2. At least 1 each of the following general and respiratory symptoms associated with influenza is present with a severity of moderate or greater: i. General symptoms (headache, feverishness or chills, muscle or joint pain, or fatigue) ii. 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
* 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:

  1. Time of the first increase in body temperature (an increase of at least 1º C from normal body temperature)
  2. 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 (including patients receiving corticosteroids not exceeding 20 mg of prednisolone or equivalent, and patients being treated for human immunodeficiency virus (HIV) infection with a cluster of differentiation 4 count \> 350 cells/mm³ within the last 6 months)
5. Neurological and neurodevelopmental disorders (including disorders of the brain, spinal cord, peripheral nerve, and muscle, e.g., cerebral palsy, epilepsy \[seizure disorders\], stroke, muscular dystrophy, or spinal cord injury)
6. Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease), excluding hypertension without any other heart-related symptoms
7. Adults aged ≥ 65 years
8. Blood disorders (such as sickle cell disease)
9. Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)
10. Morbid obesity (body mass index ≥ 40)

Other Exclusion criteria Any one of the following

* Influenza vaccination with live attenuated vaccine in the 3 months prior to randomization
* Antiviral treatment for influenza in 2 weeks prior to randomization
* Severe Hepatic and renal impairment
* Pregnant, attempting to conceive, or lactating women

Primary outcomes:
measure: Time to improvement of symptoms
timeFrame: Day 1 pretreatment upto Day 7
Secondary outcomes:
measure: Percentage change in participants positive for influenza virus titer and viral RNA at end of treatment
timeFrame: 7 days
measure: Time to alleviation of symptoms
timeFrame: Day 1 pretreatment up to Day 7
measure: Time to improvement in the 4 systemic symptoms
timeFrame: Day 1 pretreatment up to Day 7
measure: Time to improvement in the 3 respiratory symptoms
timeFrame: Day 1 pretreatment up to Day 7
measure: Time to resolution of fever
timeFrame: Day 1 pretreatment up to Day 7
measure: Percentage of participants with adverse events
timeFrame: Baseline up to Day 7
measure: Percentage of participants who had been hospitalized
timeFrame: Baseline up to Day 7
measure: Percentage of participants with influenza-related complications
timeFrame: Baseline up to Day 7
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Mazumdar Shaw Medical Centre
state: Karnataka
Study officials:
affiliation: Narayana Hrudayalaya Hospital
name: Dayanand B Yaligar, MBBS
role: PRINCIPAL_INVESTIGATOR
References: