| CTRI Number |
CTRI/2023/10/058221 [Registered on: 03/10/2023] Trial Registered Prospectively |
| Last Modified On: |
04/11/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical trial of Malbet syrup in pediatric patients with uncomplicated influenza. |
|
Scientific Title of Study
|
An open-label, single-arm clinical study to evaluate the efficacy & safety of Malbet syrup in pediatric patients with uncomplicated influenza. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/23-24/019 Version:1.00 dated 07 August 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr V G Vaidya |
| Designation |
Managing Trustee |
| Affiliation |
Lokmanya Medical Research Centre |
| Address |
Forth floor OPD 401 314 B Telco Road Chinchwad
Pune MAHARASHTRA 411033 India |
| Phone |
9822057766 |
| Fax |
- |
| Email |
vgvclinical@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gayatri Ganu |
| Designation |
Director |
| Affiliation |
Mprex Healthcare Pvt Ltd |
| Address |
501-514 crossroad building, Bhumkar square, Wakad
Pune MAHARASHTRA 411057 India |
| Phone |
8554912644 |
| Fax |
- |
| Email |
gayatri.mbgindia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Mr Manoj Gune |
| Designation |
Managing Director |
| Affiliation |
Solar Herbo Pvt. Ltd. |
| Address |
Office Flat No. 102, 1st Floor, Sairam Heights. P. Scheme No. 3, E Ward, Pratibha Nagar
Kolhapur MAHARASHTRA 416008 India |
| Phone |
9112056557 |
| Fax |
- |
| Email |
manojgune@gmail.com |
|
|
Source of Monetary or Material Support
|
| Solar Herbo Pvt. Ltd.
Office Flat No. 102, 1st Floor, Sairam Heights. P. Scheme No. 3, E Ward, Pratibha Nagar, Kolhapur- MH 416008 |
|
|
Primary Sponsor
|
| Name |
Solar Herbo Pvt. Ltd. |
| Address |
Office Flat No. 102, 1st Floor, Sairam Heights. P. Scheme No. 3, E Ward, Pratibha Nagar, Kolhapur- MH 416008 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr V G Vaidya |
Lokmanya Medical Research Centre and Hospital |
4th-floor OPD 401 314 B Telco Road Chinchwad Pune Pune MAHARASHTRA |
9822057766 - vgvclinical@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Lokmanya Medical Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J118||Influenza due to unidentified influenza virus with other manifestations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Malbet Syrup |
5 ml 3 times a day after meals for 5 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1)Male and female patients of age of 6-12 (Both inclusive) years visiting the outpatient department of the study center;2)Viral fever, cold, cough and pyrexia of unknown origin irrespective of the type of viral infection as per the discretion of investigator;3)At time of enrollment has 2 or more of the following symptoms (moderate to severe in intensity based on 5-point Linkert scale) that began 48 hours or less prior to the anticipated start of dosing with study medication: cough, sore throat, headache, nasal congestion, body aches and pains, fatigue;4)Has a fever less than or equal to 103 °F at the first visit or in the 6 hours prior if antipyretics were taken. |
|
| ExclusionCriteria |
| Details |
1.Patients who required hospitalization at the time of screening;
2.Fever > 103 °F;
3.Has taken an anti-influenza drug, or received any live attenuated influenza vaccine within 4 weeks prior to signing the informed consent;
4.Suspected bacterial respiratory infection (i.e., expectoration of purulent or mucopurulent sputum and/or infiltrate in lung observed on chest x ray, or is on antibiotics for pulmonary disease) as per discretion of investigator at the start of study;
5.Patients having any congenital abnormality or epileptic attack
6.Current use of adrenocorticosteroids (except topical preparation) or immunosuppressive drugs;
7.Any other clinical condition which may jeopardize the study outcome or patient health in any way as per discretion of investigator. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Time required to alleviation of all primary influenza symptoms and pyrexia (clinical recovery) i.e. time from the start of study treatment until alleviation of all primary influenza symptoms (i.e. cough, sore throat, headache, nasal congestion, body aches and pains, fatigue) and to resolution of pyrexia from baseline to day 5. |
screening, baseline, day 2, Day 3, Day 4 and Day 5 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Changes in time to alleviation of each of the primary influenza symptoms and pyrexia i.e. time from the start of study treatment until alleviation of each of the following influenza symptoms (cough, sore throat, headache, nasal congestion, body aches, and pains, and fatigue) and to the resolution of pyrexia from baseline to day 5. |
screening, baseline, day 2, Day 3, Day 4 and Day 5 |
|
|
Target Sample Size
|
Total Sample Size="25" Sample Size from India="25"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
05/11/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="2" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In
recent years’ viral respiratory tract infections, especially influenza viruses,
have had a major impact on communities worldwide as a result of unavailability
of effective treatment or vaccine. Besides the
development of drug resistance, emergence of mutant strains of the virus,
emergence of a more virulent strain, prohibitive costs of available drugs, time
lag between vaccine development, and unavailability of optimal
medication would pose really difficult problems,
suggests the requirement for alternative natural herbal remedies. Herbs exhibit a diverse array of biological
activities and can be effectively harnessed for managing influenza.
The lack of awareness or compliance with
guidelines on the use of decongestant/cough medicines in children may causes
contraindications. Prolong influenza illness
may cause increase in diagnosis of secondary infections or complications, child
absenteeism from playgroup, day care or school; parental absenteeism from work;
and health care service use including hospitalization, visits to general
practitioners or other health care professionals.
Traditional herbal remedies have been gaining more attention
in recent years due to accessibility, affordability, their safety, and
promising efficacy. Herbal medicines are proven for treating and combating
pathogenic infectious diseases like the common cold and influenza. Malbet Syrup
is herbal
product created with strong rationales for treating uncomplicated influenza in
pediatrics. In the initial stage of influenza, Malbet
Syrup treatment will be providing a faster clinical recovery, thus avoiding the
use of conventional treatment and its associated side effects at the same time
due to its clinically proven potent ingredients. The use of OTC medicines such as antipyretics, decongestant
and cough medicines is administered to pediatrics to minimize the discomfort of
influenza, although they are unlikely to have an impact on the course of the
illness and lower patient compliance. The ingredients in this formulation
have been proven to aid in reducing fever, cough, sore throat, headache, nasal
congestion, body aches and pains, fatigue, helps to restore normal body
functions, and overcome rigors.
With the present clinical trial, it
is an attempt to provide evidence of potential of herbal syrup is safe and
effective to treat uncomplicated influenza in pediatrics. By virtue of the
selection of the ingredients, Malbet Syrup may provide very
potent tool for controlling an array of uncomplicated influenza. |