Influenza Management With Polyherbal Formulation

NCT03365336 | Unknown

• 1 other identifier: OI-008-2017
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• Time to improvement of symptoms

  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%).

  Day 1 pretreatment upto Day 7

Secondary Outcomes (8)

• Percentage change in participants positive for influenza virus titer and viral RNA at end of treatment

  7 days

• Time to alleviation of symptoms

  Day 1 pretreatment up to Day 7

• Time to improvement in the 4 systemic symptoms

  Day 1 pretreatment up to Day 7

• Time to improvement in the 3 respiratory symptoms

  Day 1 pretreatment up to Day 7

• Time to resolution of fever

  Day 1 pretreatment up to Day 7

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Drug: polyherbal formulation; Drug: Oseltamivir 75mg

Standard Care Group

ACTIVE COMPARATOR

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.

Drug: Oseltamivir 75mg

Interventions

polyherbal formulation DRUG

Each Flu Care consist of 350 mg of polyherbal component

Also known as: Flu Care

Intervention Group

Oseltamivir 75mg DRUG

All the participant has to take 75 mg of oseltamivir for five days.

Intervention Group; Standard Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects above the age of 18 years, providing written informed consent.
• Patients with a duration of influenza symptoms confirmed by all of the following:
• Fever ≥ 38º C (axillary) during the predose examinations or within the 4 hours prior if antipyretics were taken
• 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:
• Time of the first increase in body temperature (an increase of at least 1º C from normal body temperature)
• Time when the patient experiences at least 1 new general or respiratory symptom

You may not qualify if:

• Asthma or chronic lung disease (such as chronic obstructive pulmonary disease or cystic fibrosis)
• Endocrine disorders (including diabetes mellitus)
• Residents of long-term care facilities (e.g., nursing homes)
• 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)
• 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)
• Heart disease (such as congenital heart disease, congestive heart failure, or coronary artery disease), excluding hypertension without any other heart-related symptoms
• Adults aged ≥ 65 years
• Blood disorders (such as sickle cell disease)
• Metabolic disorders (such as inherited metabolic disorders and mitochondrial disorders)
• Morbid obesity (body mass index ≥ 40)
• 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

Sponsors & Collaborators

• Composite Interceptive Med Science: lead

Study Sites (1)

Mazumdar Shaw Medical Centre

Bangalore, Karnataka, 560099, India

RECRUITING

MeSH Terms

Conditions

Influenza, Human

Interventions

Oseltamivir

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Dayanand B Yaligar, MBBS

  Narayana Hrudayalaya Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alben Sigamani, MD

CONTACT

8884431444; alben.sigamani.dr@nhhospitals.org

Sanjaya Chauhan, Pharm.D

CONTACT

9611252350; drsanjayachauhan49@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel follow up of two groups randomly allocated through a central randomization process.

Study Record Dates

• First Submitted: December 2, 2017
• First Posted: December 7, 2017
• Study Start: February 1, 2018
• Primary Completion: May 15, 2018
• Study Completion: May 15, 2018
• Last Updated: April 11, 2018

Record last verified: 2018-04

Locations

IN (1)