Health Condition 1: J398- Other specified diseases of upperrespiratory tract
Conditions
Interventions
Intervention1: ParActin: Two capsules/day (One capsule to be taken 30 minutes before breakfast & one capsule to be taken 30 minutes before dinner).
Control Intervention1: Placebo: Two capsules/day (On
Sponsors
Vedic Lifesciences Pvt. Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria: 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 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: a) For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day. b) For women: More than 7 SAD/week or more than 3 SAD in a day. c) Binge drinkers, defined as 5 or more SAD for men, in a 2-hour time frame d) 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 per alcohol), 8.5 ounces of malt liquor (9 per alcohol), 5 ounces of wine (12 per alcohol), 3.5 ounces of fortified wine (example sherry or port), or 1.5 ounces of liquor (distilled spirits 40 per alcohol) 21. Those who have clinically significant disorder of cardiovascular, endocrine, lymphatic, respiratory, hepatobiliary, urinary, reproductive, central nervous system, musculoskeletal an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of investigational products on participant’s severity of common cold like symptoms as reduction in the incremental Area Under the Curve (iAUC) of Wisconsin Upper Respiratory Symptom Survey-21 total severity score. Timepoint: During Upper respiratory tract infection episodes | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the effect of investigational products on Time (in days) taken to resolution of common cold like symptoms with resolution deemed to occur when participant reports being 0 equal not sick as per Wisconsin Upper Respiratory Symptom Survey-21 for two consecutive days during the treatment periodTimepoint: Every day Throughout the study;To evaluate the effect of investigational products on percentage of participants with unresolved common cold symptoms being those who do not report being 0 equal not sick as per Wisconsin Upper Respiratory Symptom Survey-21 till the end of the treatment period.Timepoint: Every day Throughout the study;To evaluate the effect of investigational products on Percentage of population with minimal important difference of = 10.3 as per change in Wisconsin Upper Respiratory Symptom Survey-21 total score. (daily score will be analysed in study).Timepoint: Every day Throughout the study;To evaluate the effect of investigational products On number of days taken to be afebrile (temp less than 100 F or less than 37.7 C) in the population with fever (temp =100 F or =37.7 C ) at baseline- as assessed by 10-point visual analogue scaleTimepoint: Every day Throughout the study;To evaluate the effect of investigational products on Percentage population with fever during the studyTimepoint: Every day Throughout the study;To evaluate the effect of investigational products on Quality of life as assessed by WURSS QoLTimepoint: Day 0, day 4 and day 8;To evaluate the effect of investigational products on Daily work productivity as assessed by Question no. 6, Work Productivity and Activity Impairment Questionnaire (WPAI) Timepoint: Day 0, day 4 and day 8 | — |
Countries
India
Contacts
Public ContactDr Sonal Raote
Vedic Lifesciences Pvt. Ltd.
Outcome results
None listed