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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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