Assessing the effectiveness of ParActin® for upper respiratory infections

A Double-blind, Randomized, Placebo-Controlled, Comparative Study for Assessing the Efficacy and Safety of ParActin® in Individuals With Upper Respiratory Tract Infections (URTI)

This study is testing if ParActin® can help people with upper respiratory infections feel better compared to a placebo.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 16 Years to 50 Years
• Sex: All
• Sponsor: Vedic Lifesciences Pvt. Ltd. (industry)
• Locations: 9 sites (Nashik, Maharashtra and 8 other locations)
• Trial ID: NCT06355661 on ClinicalTrials.gov

What this trial studies

This clinical trial is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of ParActin® in individuals suffering from upper respiratory tract infections. A total of approximately 150 participants will be randomized to receive either the active intervention or a placebo over a duration of 7 days. Participants will be screened based on specific inclusion criteria, including age, symptom severity, and history of frequent colds. The study aims to determine whether ParActin® can effectively alleviate symptoms associated with these infections.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy males and females aged 18 to 50 who exhibit symptoms of acute upper respiratory tract infections.

Not a fit: Patients with high-grade fever or a history of allergic rhinitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for individuals suffering from upper respiratory tract infections.

How similar studies have performed: While this approach has been explored in various contexts, the specific use of ParActin® for upper respiratory infections is relatively novel.

Eligibility criteria

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 by the 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 not more 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 and requirements.

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, pulmonary fibrosis or Asthma.
4. Individuals with rhinitis medicamentosa, chronic cough of bacterial, fungal or other known 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 reconstructive surgery etc.
8. Individuals with history of heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
9. Individuals with history of immunocompromised state immune system with/ without organ transplant
10. Individuals with known or suspected hypersensitivity or intolerance to herbal products
11. Individuals diagnosed with Sickle cell disease, Thalassemia, Type I/ II Diabetes mellitus, Cystic fibrosis
12. Diagnosed cases of Uncontrolled hypertension as assessed by a systolic blood pressure ≥ to 140mmHg and diastolic blood pressure ≥ to 90mmHg
13. Those not willing to abstain from home based cold remedies that include but are not limited to steam inhalation, decoctions, vapour rub, ginger supplement, decoctions, or any form of dietary and/or herbal supplements during the entirety of study participation period.
14. Those who have been vaccinated for influenza, swine flu 3 months prior to screening visit.
15. Those who have taken within one week of the start of the study or require during study antibiotics, antivirals, steroids, nasal decongestants, antihistamines herbal remedies, 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 currently taking psychoneurological drugs, such as antidepressants.
17. Those who have participated in other clinical study within 30 days, prior to the screening visit or plan to participate in other clinical study during the study period.
18. Individuals with substance abuse as per last two-year history that includes the use of 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 of smokeless tobacco.
20. Individuals with heavy alcohol consumption, defined as:

    1. For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day.
    2. For women: More than 7 SAD/week or more than 3 SAD in a day.
    3. Binge drinkers, defined as 5 or more SAD for men, in a 2-hour time frame.
    4. 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 malt liquor (\~9% alcohol), 5 ounces of wine (\~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry or port), or 1.5 ounces of liquor (distilled spirits; \~40% alcohol)
21. Those who have clinically significant disorder/s of cardiovascular, endocrine, lymphatic, respiratory, hepatobiliary, urinary, reproductive, central nervous system, musculoskeletal and digestive systems.
22. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
23. Any condition that could, in the opinion of the investigator, preclude the individual's ability to successfully and safely complete the study or that may confound study outcomes.

Where this trial is running

Nashik, Maharashtra and 8 other locations

• Life care hospital — Nashik, Maharashtra, India (RECRUITING)
• ENT Vertigo Clinic — Pune, Maharashtra, India (RECRUITING)
• Jawaharlal Nehru Medical College — Ajmer, Rajasthan, India (RECRUITING)
• Human Care Hospital — Lucknow, Uttar Pradesh, India (RECRUITING)
• Shubham Sudbhawana Super Speciality Hospital — Varanasi, Uttar Pradesh, India (RECRUITING)
• Janta Hospital — Varanasi, Uttar Pradesh, India (NOT_YET_RECRUITING)
• Gastron Clinic — Delhi, India (RECRUITING)
• Good health Clinic — Delhi, India (RECRUITING)
• Tulsi Multispecility Hospital — Delhi, India (RECRUITING)

Study contacts

• Study coordinator: Dr. Shalini Srivastava, MBBS, MD

Conditions: Upper Respiratory Tract Infections