Phase
Condition
Respiratory Syncytial Virus (Rsv) Infection
Treatment
ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule
MCC: 400 mg (± 10%) per Capsule
Clinical Study ID
Ages 16-50 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male and female aged between 18 and 50 years as of the screening date.
Individuals with symptoms of acute upper respiratory tract infection as assessed bythe investigator at the time of screening.
BMI ≤ 29.9 kg/m2.
Upper respiratory tract infection symptoms present for at least 24 hours but notmore than 48 hours prior to screening visit.
Those having a score of ≥ 5 for at least 2 symptoms out of runny nose, plugged nose,sneezing or sore throat, on the WURSS-21.
History of frequent common cold with past episode duration of at least 4 days.
Must be literate and have the ability to complete the study-based questionnaires andrequirements.
Exclusion
Exclusion Criteria:
High grade fever defined as body temperature ≥ 39ºC (≥ 102.2 ºF)
With a history of allergy (allergic rhinitis) along with symptoms such as sneezing,runny nose and red, watery and itchy eyes.
Individuals with history of Chronic obstructive pulmonary disease, pulmonaryfibrosis or Asthma.
Individuals with rhinitis medicamentosa, chronic cough of bacterial, fungal or otherknown origin.
Individuals requiring hospitalization or likely to be hospitalised due to URTI.
Individuals with common cold for the first time.
Individuals with anatomical nasal obstruction/ deformity or nasal reconstructivesurgery etc.
Individuals with history of heart conditions, such as heart failure, coronary arterydisease, or cardiomyopathies
Individuals with history of immunocompromised state immune system with/ withoutorgan transplant
Individuals with known or suspected hypersensitivity or intolerance to herbalproducts
Individuals diagnosed with Sickle cell disease, Thalassemia, Type I/ II Diabetesmellitus, Cystic fibrosis
Diagnosed cases of Uncontrolled hypertension as assessed by a systolic bloodpressure ≥ to 140mmHg and diastolic blood pressure ≥ to 90mmHg
Those not willing to abstain from home based cold remedies that include but are notlimited to steam inhalation, decoctions, vapour rub, ginger supplement, decoctions,or any form of dietary and/or herbal supplements during the entirety of studyparticipation period.
Those who have been vaccinated for influenza, swine flu 3 months prior to screeningvisit.
Those who have taken within one week of the start of the study or require duringstudy antibiotics, antivirals, steroids, nasal decongestants, antihistamines herbalremedies, Vitamin C or Zinc to alleviate cold symptoms.
Those who have severe mental illnesses, such as dementia, Parkinson's disease,Alzheimer's Disease, depression or anxiety disorders, or those who are currentlytaking psychoneurological drugs, such as antidepressants.
Those who have participated in other clinical study within 30 days, prior to thescreening visit or plan to participate in other clinical study during the studyperiod.
Individuals with substance abuse as per last two-year history that includes the useof but is not limited to drugs such as cocaine, amphetamine, marijuana etc.
Individuals having a history of smoking or currently smoking or using any form ofsmokeless tobacco.
Individuals with heavy alcohol consumption, defined as:
For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD ina day.
For women: More than 7 SAD/week or more than 3 SAD in a day.
Binge drinkers, defined as 5 or more SAD for men, in a 2-hour time frame.
Binge drinkers, defined as 4 or more SAD for Women, in a 2-hour time frame. (NOTE - A standard alcoholic drink contains approximately 14 grams of alcohol,which is equivalent to 12 ounces of beer (
5% alcohol), 8.5 ounces of maltliquor (9% alcohol), 5 ounces of wine (~12% alcohol), 3.5 ounces of fortifiedwine (e.g., sherry or port), or 1.5 ounces of liquor (distilled spirits; ~40%alcohol)Those who have clinically significant disorder/s of cardiovascular, endocrine,lymphatic, respiratory, hepatobiliary, urinary, reproductive, central nervoussystem, musculoskeletal and digestive systems.
Females who are pregnant/planning to be pregnant/lactating or taking any oralcontraceptives.
Any condition that could, in the opinion of the investigator, preclude theindividual's ability to successfully and safely complete the study or that mayconfound study outcomes.
Study Design
Connect with a study center
Life care hospital
Nashik, Maharashtra 422009
IndiaActive - Recruiting
ENT Vertigo Clinic
Pune, Maharashtra 411045
IndiaActive - Recruiting
Jawaharlal Nehru Medical College
Ajmer, Rajasthan 305001
IndiaActive - Recruiting
Human Care Hospital
Lucknow, Uttar Pradesh 226012
IndiaActive - Recruiting
Janta Hospital
Varanasi, Uttar Pradesh 221011
IndiaSite Not Available
Shubham Sudbhawana Super Speciality Hospital
Varanasi, Uttar Pradesh 221005
IndiaActive - Recruiting
Biswas health care & Diagnostic Centre
Nainital, Uttaranchal
IndiaSite Not Available
Gastron Clinic
Delhi, 110015.
IndiaActive - Recruiting
Good health Clinic
Delhi, 110027
IndiaActive - Recruiting
Tulsi Multispecility Hospital
Delhi, 110094
IndiaActive - Recruiting
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