Influenza Management With Polyherbal Formulation

Composite Interceptive Med Science

Status: Unknown

Conditions: Influenza

Treatments: Drug: Oseltamivir 75mg; Drug: polyherbal formulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT03365336

OI-008-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention Group

Experimental group

Description:

Each Flu Care capsule consists of combination of seven polyherbal formulation (350 mg). Participant will be instructed to take one capsule thrice daily at a fixed time in the day for the study duration of 7 days along with 75 mg of Oseltamivir.

Treatment:

Drug: polyherbal formulation

Drug: Oseltamivir 75mg

Standard Care Group

Active Comparator group

Description:

Standard of care consist of 75 mg of Oseltamivir for five days and any other required provision of care. These will be determined on case by case basis by research clinician.

Treatment:

Drug: Oseltamivir 75mg