ClinicalTrials.gov
ClinicalTrials.gov Menu

Influenza Management With Polyherbal Formulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03365336
Recruitment Status : Recruiting
First Posted : December 7, 2017
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Organic India

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.

Condition or disease Intervention/treatment Phase
Influenza Drug: polyherbal formulation Drug: Oseltamivir 75mg Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel follow up of two groups randomly allocated through a central randomization process.
Masking: None (Open Label)
Masking Description: Open label study
Primary Purpose: Treatment
Official Title: Indian Herbal Medicine for Influenza - Randomized Controlled Study
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : May 15, 2018
Estimated Study Completion Date : May 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
Drug Information available for: Oseltamivir
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intervention Group
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
Each Flu Care consist of 350 mg of polyherbal component
Other Name: Flu Care
Drug: Oseltamivir 75mg
All the participant has to take 75 mg of oseltamivir for five days.
Active Comparator: Standard Care Group
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
All the participant has to take 75 mg of oseltamivir for five days.



Primary Outcome Measures :
  1. Time to improvement of symptoms [ Time Frame: Day 1 pretreatment upto Day 7 ]
    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%).


Secondary Outcome Measures :
  1. Percentage change in participants positive for influenza virus titer and viral RNA at end of treatment [ Time Frame: 7 days ]
    Defined as the percentage of patients whose virus titer and ribonucleic acid (RNA) load are become less than the lower limit of quantification among those assessed for virus titer and RNA load. RNA load is measured by reverse transcription polymerase chain reaction (RT-PCR).

  2. Time to alleviation of symptoms [ Time Frame: Day 1 pretreatment up to Day 7 ]
    Time to alleviation of symptoms is defined as the time between the initiation of the study treatment and the alleviation of influenza symptoms. The alleviation of influenza symptoms is defined as the time when all of 7 influenza symptoms (cough, sore throat, headache, nasal congestion, feverishness or chills, muscle or joint pain, and fatigue) have been assessed by the patient.

  3. Time to improvement in the 4 systemic symptoms [ Time Frame: Day 1 pretreatment up to Day 7 ]
    Defined as the time between the initiation of the study treatment and the improvement in the 4 systemic symptoms symptoms (headache, feverishness or chills, muscle or joint pain, and fatigue).

  4. Time to improvement in the 3 respiratory symptoms [ Time Frame: Day 1 pretreatment up to Day 7 ]
    Defined as the time between the initiation of the study treatment and the improvement in the 3 respiratory symptoms (cough, sore throat, and nasal congestion).

  5. Time to resolution of fever [ Time Frame: Day 1 pretreatment up to Day 7 ]

    Defined as the time between the initiation of the study treatment and the resolution of fever.

    The resolution of fever is defined as the time when the patient's self-measured temperature becomes less than 37º C.


  6. Percentage of participants with adverse events [ Time Frame: Baseline up to Day 7 ]
  7. Percentage of participants who had been hospitalized [ Time Frame: Baseline up to Day 7 ]
  8. Percentage of participants with influenza-related complications [ Time Frame: Baseline up to Day 7 ]
    Defined as the percentage of patients who experience each influenza-related complication (hospitalization, death, sinusitis, otitis media, bronchitis, and radiologically-confirmed pneumonia) as an adverse event after the initiation of study treatment.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03365336


Contacts
Contact: Alben Sigamani, MD 8884431444 alben.sigamani.dr@nhhospitals.org
Contact: Sanjaya Chauhan, Pharm.D 9611252350 drsanjayachauhan49@gmail.com

Locations
India
Mazumdar Shaw Medical Centre Recruiting
Bangalore, Karnataka, India, 560099
Contact: Alben Sigamani, MD    8884431444    alben.sigamani.dr@nhhospitals.org   
Contact: Sanjaya Chauhan, Pharm.D    9611252350    drsanjayachauhan49@gmail.com   
Sponsors and Collaborators
Organic India
Investigators
Principal Investigator: Dayanand B Yaligar, MBBS Narayana Hrudayalaya Hospital

Responsible Party: Organic India
ClinicalTrials.gov Identifier: NCT03365336     History of Changes
Other Study ID Numbers: OI-008-2017
First Posted: December 7, 2017    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Oseltamivir
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action