| CTRI Number |
CTRI/2018/01/011387 [Registered on: 17/01/2018] Trial Registered Prospectively |
| Last Modified On: |
13/09/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Management of Flu with Herbal Medicine |
|
Scientific Title of Study
|
Indian Herbal Medicine for Influenza- Randomized Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT03365336 |
ClinicalTrials.gov |
| OI-008-2017 Version 2.0 Date 01 November 2017 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Dayanand B Yaligar |
| Designation |
Consultant-Cardiology |
| Affiliation |
Narayana Hrudayalaya Hospital |
| Address |
1st Floor, A Block, Mazumdar Shaw Medical Centre, Narayana Health City, Bommasandra Industrial Area, Bangalore 560099, Karnataka State, INDIA
Bangalore
KARNATAKA
560099
India |
| Phone |
9980576966 |
| Fax |
08884431444 |
| Email |
hrudayaplus@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alben Sigamani |
| Designation |
Investigator |
| Affiliation |
Narayana Hrudayalaya Hospital |
| Address |
1st Floor, B Block, Mazumdar Shaw Medical Centre, Narayana Health City, Bommasandra Industrial Area, Bangalore 560099, Karnataka State, INDIA
Bangalore
KARNATAKA
560099
India |
| Phone |
8884431444 |
| Fax |
08884431444 |
| Email |
alben.sigamani.dr@narayanahealth.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjaya Chauhan |
| Designation |
Clinical Research Scientist |
| Affiliation |
Organic India |
| Address |
6th floor, B block, Room no.33 Mazumdar Shaw Medical Centre, Narayana Health City, Bommasandra Industrial Area, Bangalore 560099, Karnataka State, INDIA
Bangalore
KARNATAKA
560099
India |
| Phone |
9611252350 |
| Fax |
|
| Email |
drsanjayachauhan49@gmail.com |
|
|
Source of Monetary or Material Support
|
| Organic India Private Limited – R&D 8th Floor, A Block, Mazumdar Shaw Cancer Centre Narayana Health City, Bommasandra Industrial Area Bangalore 560099, Karnataka State, INDIA |
|
|
Primary Sponsor
|
| Name |
Organic India |
| Address |
Organic India Private Limited – R&D 8th Floor, A Block, Mazumdar Shaw Cancer Centre Narayana Health City, Bommasandra Industrial Area Bangalore 560099, Karnataka, India |
| Type of Sponsor |
Other [Herbal Supplement Manufacturer] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrikant V Deshpande |
Ashirwad Hospital and Research Centre |
Ground floor, Room no.5,near Jijamata Udyan, Maratha section, Ulhasnagar - 421004
Thane
MAHARASHTRA |
919822017445
writetoshrikant@rediffmail.com |
| Dr Dayanand B Yaligar |
Narayana Hrudayalaya Limited Mazumdar Shaw Medical Centre |
Department of Clinical Research, 6th Floor, B Block, Narayana Health City, Bommasandra Industrial Area, Bangalore 560099, Karnataka, India
Bangalore
KARNATAKA |
9980576966
hrudayaplus@gmail.com |
| Dr Prakash Kaurani |
Sai Criticare Hospital |
Block C-1, Room no. 2, Opp. Roshan Apartment, Venus Netaji road, Ulhasnagar - 421004
Thane
MAHARASHTRA |
02512530040
criticarehosp@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Ashirwad Ethics Committee |
Approved |
| Ashirwad Ethics Committee |
Approved |
| Narayana Health Medical Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Influenza, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FluCare Capsule |
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. |
| Comparator Agent |
Standard of Care Group- Active Comparator |
Standard of care consist of 75 mg of Oseltamivir twice daily for five days and any other required provision of care. These will be determined on case by case basis by research clinician. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects above the age of 18 years, providing written informed consent.
2. Patients with a duration of influenza symptoms confirmed by all of the following:
i. Fever ≥ 38º C (axillary) during the predose examinations or within the 4 hours prior if antipyretics were taken
ii. At least 1 each of the following general and respiratory symptoms associated with influenza is present with a severity of moderate or greater: a. General symptoms (headache, feverishness or chills, muscle or joint pain, or fatigue) b. 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
3. 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:
a. Time of the first increase in body temperature (an increase of at least 1º C from normal body temperature)
b. Time when the patient experiences at least 1 new general or respiratory symptom |
|
| ExclusionCriteria |
| Details |
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
5. Neurological and neurodevelopmental disorders
6. Heart disease (Congenital heart disease, Congestive heart failure)
7. Adults aged 65 years or more
8. Blood fisorders
9. Metabolic disorders
10. Morbid Obesity (BMI more than 40)
Other Exclusion criteria: Any one of the following
1. Influenza vaccination with live attenuated vaccine in the 3 months prior to randomization
2. Antiviral treatment for influenza in 2 weeks prior to randomization
3. Severe Hepatic and renal impairment
4. Pregnant, attempting to conceive, or lactating women
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
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 Outcome
|
| Outcome |
TimePoints |
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). |
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. |
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). |
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). |
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 patients self-measured temperature becomes less than 37º C. |
Day 1 pretreatment up to Day 7 |
| Percentage of participants with adverse events |
Baseline up to Day 7 |
| Percentage of participants who had been hospitalized |
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. |
Baseline up to Day 7 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
27/01/2018 |
| Date of Study Completion (India) |
10/06/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Publication Committee will decide. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
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.
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. |