A clinical trial of Malbet capsules in adult patients with uncomplicated influenza.

Not yet recruiting

Conditions: Influenza due to unidentified influenza virus with other manifestations,

Registration Number: CTRI/2023/10/058885

Lead Sponsor: Solar Herbo Pvt. Ltd.

Brief Summary: Inrecent yearsâ€™ viral respiratory tract infections, especially influenza viruses,have had a major impact on communities worldwide as a result of unavailabilityof effective treatment or vaccine. Besides thedevelopment of drug resistance, emergence of mutant strains of the virus,emergence of a more virulent strain, prohibitive costs of available drugs, timelag between vaccine development, and unavailability of optimalmedication would pose really difficult problems,suggests the requirement for alternative natural herbal remedies. Herbs exhibit a diverse array of biological activitiesand can be effectively harnessed for managing influenza.

Traditional herbal remedies have been gaining more attentionin recent years due to accessibility, affordability, their safety, andpromising efficacy. Herbal medicines are proven for treating and combatingpathogenic infectious diseases like the common cold and influenza. Malbetcapsule is herbalproduct created with strong rationales for treating uncomplicated influenza inadults. In the initial stage of influenza, Malbetcapsule treatment will be provide a faster clinical recovery, thus avoiding theuse of conventional treatment and its associated side effects at the same timedue to its clinically proven potent ingredients. A common practice in influenzatreatment is the use of antibiotics is doubly misguided, since antibiotics haveno effect on an infection of solely viral origin, and the use of antibioticswill generate the risk of antibiotic resistance and their side effects. The ingredients in this formulationare Kutaj beej, Saptaparni, Kutaki, Patol, Kalimirich, Laghusutshekhar, andTribhuvankirti etc. These ingredients have been proven to aid in reducingfever, controls nausea, vomiting and gastritis, helps to restore normal bodyfunctions, alleviate loss of appetite and overcome rigors.

Kutakiacts very effectively in recurrent fever, especially in fever, pyrexia ofunknown origin. It is also use in management of sore throat along with it helpsto expel excessive sputum from the lungs and provides relief from cough. Kalimirich is beneficial for cough and respiratoryproblems.Saptaparni is used to treat dysentery and fever. It is evident that Tribhuvankirti is an herbal extract that provides immediaterelief from cough, body aches, cold and fever. It treats the problem at itsroot and fortifies the system from viruses. Laghusutshekharprovide relief from headache, migraine and fatigue etc.by improving blood circulation and providing strength to the brain, hence helpsto alleviate the painful conditions and other discomfort .

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 25

Inclusion Criteria

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 Â°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.

Exclusion Criteria

1.Patients who required hospitalization at the time of screening; 2.Fever > 103 Â°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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): Lokmanya Medical Research Centre and Hospital
🇮🇳
Pune, MAHARASHTRA, India
Lokmanya Medical Research Centre and Hospital
🇮🇳Pune, MAHARASHTRA, India
Dr V G Vaidya
Principal investigator
9822057766
vgvclinical@gmail.com