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CTRI Number  CTRI/2023/10/058885 [Registered on: 19/10/2023] Trial Registered Prospectively
Last Modified On: 18/11/2023
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 capsules in adult patients with uncomplicated influenza. 
Scientific Title of Study   A clinical study to evaluate the efficacy & safety of Malbet capsules in adult patients with uncomplicated influenza. 
Trial Acronym  Nil 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
MHC/CT/23-24/018 Version: 2.00 dated 23 October 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  Fourth 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, T. 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, T. 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
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee Lokmanya Medical Research Centre  Approved 
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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Malbet capsule, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 340(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 5 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -
Intervention  Malbet capsules  One capsule with warm water 3 times daily after meals for 5 days. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Male and female patients of age 18 years and above;2)At the 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 pain, fatigue;3)Fever less than or equal to 103 °F;4)Viral fever, cold, cough and pyrexia of unknown origin irrespective of the type of viral infection as per the discretion of investigator; 5)Comorbid patient on stable medication for the last three months, with no worsening of symptoms and/or need for hospitalization; or can be enrolled into the study as per discretion of investigator.  
 
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.Has underlying chronic respiratory disease; includes bronchial asthma if currently experience asthma symptoms, requires current asthma treatment, or has had an asthma attack in the past year;
5.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 investigators at start of study;
6.Current use of adrenocorticosteroids (except topical preparation) or immunosuppressive drugs;
7.Has a serious chronic disease, history of alcohol or drug abuse within preceding 2 years, psychiatric illness not well controlled (not on stable regimen > 1 year), or is deemed by the investigator to be ineligible for any reason;
8.Has renal insufficiency requiring hemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
9.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
Modification(s)  
Outcome  TimePoints 
1.Time required to alleviate 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.  Baseline, Day 2, Day 3, Day 4 and Day 5 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1.Changes in time to alleviation of each of the primary influenza symptoms & pyrexia ie time from the start of study treatment until alleviation of each of the following influenza symptoms (cough, sore throat, headache, nasal congestion, body aches, & pains, & fatigue) & to the resolution of pyrexia from baseline to day 5.
2.Change in secondary influenza symptom i.e. loss of appetite based on Appetite & Food Satisfaction Questionnaire from baseline to day 5 
Screening, Baseline, Day 2, Day 3, Day 4 & 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)   23/10/2023 
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.

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 capsule is herbal product created with strong rationales for treating uncomplicated influenza in adults. In the initial stage of influenza, Malbet capsule treatment will be provide 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. A common practice in influenza treatment is the use of antibiotics is doubly misguided, since antibiotics have no effect on an infection of solely viral origin, and the use of antibiotics will generate the risk of antibiotic resistance and their side effects. The ingredients in this formulation are Kutaj beej, Saptaparni, Kutaki, Patol, Kalimirich, Laghusutshekhar, and Tribhuvankirti etc. These ingredients have been proven to aid in reducing fever, controls nausea, vomiting and gastritis, helps to restore normal body functions, alleviate loss of appetite and overcome rigors.

Kutaki acts very effectively in recurrent fever, especially in fever, pyrexia of unknown origin. It is also use in management of sore throat along with it helps to expel excessive sputum from the lungs and provides relief from cough. Kalimirich is beneficial for cough and respiratory problems. Saptaparni is used to treat dysentery and fever. It is evident that Tribhuvankirti is an herbal extract that provides immediate relief from cough, body aches, cold and fever. It treats the problem at its root and fortifies the system from viruses. Laghusutshekhar provide relief from headache, migraine and fatigue etc. by improving blood circulation and providing strength to the brain, hence helps to alleviate the painful conditions and other discomfort .

With the present clinical trial, it is an attempt to provide evidence of potential of herbal capsule is safe and effective to treat uncomplicated influenza in adults. By virtue of the selection of the ingredients, Malbet capsule may provide very potent tool for controlling an array of uncomplicated influenza.

 
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