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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Other 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. |