InfluenzaNCT03365336
Influenza Management With Polyherbal Formulation
A study testing polyherbal formulation and Oseltamivir 75mg in people with Influenza, run by Composite Interceptive Med Science at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Influenza
- What is being tested?
- polyherbal formulation and Oseltamivir 75mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 1 Feb 2018to 15 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients will be considered at high risk of influenza complications due to the presence of at least 1 of the following inclusion criteria:
- 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)
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- 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)
- 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 locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Mazumdar Shaw Medical Centre
Bangalore, Karnataka, 560099
Alben Sigamani, MD, 8884431444, alben.sigamani.dr@nhhospitals.org
Sanjaya Chauhan, Pharm.D, 9611252350, drsanjayachauhan49@gmail.com
About this study
Official title: Indian Herbal Medicine for Influenza - Randomized Controlled Study
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.
Read the 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.
- Conditions
- Influenza
- Being tested
- polyherbal formulation, Oseltamivir 75mg
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyherbal formulationDrug
Also called Flu Care
Each Flu Care consist of 350 mg of polyherbal component
Oseltamivir 75mgDrug
All the participant has to take 75 mg of oseltamivir for five days.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Oseltamivir 75mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 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
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).
Measured: 7 days
Time to alleviation of symptoms
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.
Measured: Day 1 pretreatment up to Day 7
Time to improvement in the 4 systemic symptoms
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).
Measured: Day 1 pretreatment up to Day 7
Time to improvement in the 3 respiratory symptoms
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).
Measured: Day 1 pretreatment up to Day 7
Time to resolution of fever
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.
Measured: Day 1 pretreatment up to Day 7
Percentage of participants with adverse events
Measured: Baseline up to Day 7
Percentage of participants who had been hospitalized
Measured: Baseline up to Day 7
Percentage of participants with influenza-related complications
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.
Measured: Baseline up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Feb 2018
- Primary completion15 May 2018 (estimated)
- Study completion15 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel follow up of two groups randomly allocated through a central randomization process.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Composite Interceptive Med Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dayanand B Yaligar, MBBS, Principal investigator, Narayana Hrudayalaya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365336
- Sponsor's protocol ID
- OI-008-2017
- Status last verified
- Apr 2018
- First submitted
- 2 Dec 2017
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indian Herbal Medicine for Influenza - Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03365336
- Acronym / sponsor ID
- OI-008-2017
- Conditions
- Influenza
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Composite Interceptive Med ScienceIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 15 May 2018 (estimated)
- Study completion
- 15 May 2018 (estimated)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel follow up of two groups randomly allocated through a central randomization process.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: polyherbal formulation, Drug: Oseltamivir 75mgEach 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. |
| Standard Care Group | Active comparator | Drug: Oseltamivir 75mgStandard 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects above the age of 18 years, providing written informed consent.
- Patients with a duration of influenza symptoms confirmed by all of the following:
- 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:
Key exclusion criteria (16 listed)
- Patients will be considered at high risk of influenza complications due to the presence of at least 1 of the following inclusion criteria:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| polyherbal formulationAlso: Flu CareEach Flu Care consist of 350 mg of polyherbal component | Drug | Intervention Group |
| Oseltamivir 75mgAll the participant has to take 75 mg of oseltamivir for five days. | Drug | Intervention Group, Standard Care Group |
Primary outcome
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%).
8 secondary outcomes
Percentage change in participants positive for influenza virus titer and viral RNA at end of treatment
Time frame: 7 days
Time to alleviation of symptoms
Time frame: Day 1 pretreatment up to Day 7
Time to improvement in the 4 systemic symptoms
Time frame: Day 1 pretreatment up to Day 7
Time to improvement in the 3 respiratory symptoms
Time frame: Day 1 pretreatment up to Day 7
Time to resolution of fever
Time frame: Day 1 pretreatment up to Day 7
Percentage of participants with adverse events
Time frame: Baseline up to Day 7
Percentage of participants who had been hospitalized
Time frame: Baseline up to Day 7
Percentage of participants with influenza-related complications
Time frame: Baseline up to Day 7
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dayanand B Yaligar, MBBS principal investigator
Narayana Hrudayalaya Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polyherbal formulation and Oseltamivir 75mg in people with Influenza, run by Composite Interceptive Med Science at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alben Sigamani, MD (8884431444, alben.sigamani.dr@nhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to improvement of symptoms (time frame: Day 1 pretreatment upto Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2018.