A Study for Assessing the Efficacy and Safety ParActin® in Individuals With Upper Respiratory Tract Infections

Last updated: June 14, 2024
Sponsor: Vedic Lifesciences Pvt. Ltd.
Overall Status: Active - Recruiting

Phase

N/A

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

NCT06355661
HP/231102/PA/URTI
  • Ages 16-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The present study is a randomized, double-blind, placebo-controlled, comparative study. 176 individuals will be screened, and considering a screening failure rate of 15 percent approximately 150 will be randomized in a ratio of 1:1 to receive either IP or placebo and will be assigned a unique randomization code. Each group will have at least 60 completed participants after accounting for a dropout/withdrawal rate of 20percent. The intervention duration for all the study participants is 7 days

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male and female aged between 18 and 50 years as of the screening date.

  2. Individuals with symptoms of acute upper respiratory tract infection as assessed bythe investigator at the time of screening.

  3. BMI ≤ 29.9 kg/m2.

  4. Upper respiratory tract infection symptoms present for at least 24 hours but notmore than 48 hours prior to screening visit.

  5. 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.

  6. History of frequent common cold with past episode duration of at least 4 days.

  7. Must be literate and have the ability to complete the study-based questionnaires andrequirements.

Exclusion

Exclusion Criteria:

  1. High grade fever defined as body temperature ≥ 39ºC (≥ 102.2 ºF)

  2. With a history of allergy (allergic rhinitis) along with symptoms such as sneezing,runny nose and red, watery and itchy eyes.

  3. Individuals with history of Chronic obstructive pulmonary disease, pulmonaryfibrosis or Asthma.

  4. Individuals with rhinitis medicamentosa, chronic cough of bacterial, fungal or otherknown origin.

  5. Individuals requiring hospitalization or likely to be hospitalised due to URTI.

  6. Individuals with common cold for the first time.

  7. Individuals with anatomical nasal obstruction/ deformity or nasal reconstructivesurgery etc.

  8. Individuals with history of heart conditions, such as heart failure, coronary arterydisease, or cardiomyopathies

  9. Individuals with history of immunocompromised state immune system with/ withoutorgan transplant

  10. Individuals with known or suspected hypersensitivity or intolerance to herbalproducts

  11. Individuals diagnosed with Sickle cell disease, Thalassemia, Type I/ II Diabetesmellitus, Cystic fibrosis

  12. Diagnosed cases of Uncontrolled hypertension as assessed by a systolic bloodpressure ≥ to 140mmHg and diastolic blood pressure ≥ to 90mmHg

  13. 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.

  14. Those who have been vaccinated for influenza, swine flu 3 months prior to screeningvisit.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. Individuals having a history of smoking or currently smoking or using any form ofsmokeless tobacco.

  20. Individuals with heavy alcohol consumption, defined as:

  21. For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD ina day.

  22. For women: More than 7 SAD/week or more than 3 SAD in a day.

  23. Binge drinkers, defined as 5 or more SAD for men, in a 2-hour time frame.

  24. 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)

  25. Those who have clinically significant disorder/s of cardiovascular, endocrine,lymphatic, respiratory, hepatobiliary, urinary, reproductive, central nervoussystem, musculoskeletal and digestive systems.

  26. Females who are pregnant/planning to be pregnant/lactating or taking any oralcontraceptives.

  27. 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

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule
Phase:
Study Start date:
April 05, 2024
Estimated Completion Date:
July 30, 2024

Connect with a study center

  • Life care hospital

    Nashik, Maharashtra 422009
    India

    Active - Recruiting

  • ENT Vertigo Clinic

    Pune, Maharashtra 411045
    India

    Active - Recruiting

  • Jawaharlal Nehru Medical College

    Ajmer, Rajasthan 305001
    India

    Active - Recruiting

  • Human Care Hospital

    Lucknow, Uttar Pradesh 226012
    India

    Active - Recruiting

  • Janta Hospital

    Varanasi, Uttar Pradesh 221011
    India

    Site Not Available

  • Shubham Sudbhawana Super Speciality Hospital

    Varanasi, Uttar Pradesh 221005
    India

    Active - Recruiting

  • Biswas health care & Diagnostic Centre

    Nainital, Uttaranchal
    India

    Site Not Available

  • Gastron Clinic

    Delhi, 110015.
    India

    Active - Recruiting

  • Good health Clinic

    Delhi, 110027
    India

    Active - Recruiting

  • Tulsi Multispecility Hospital

    Delhi, 110094
    India

    Active - Recruiting

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