protocolSection identificationModule nctId: NCT06355661, orgStudyIdInfo id: HP/231102/PA/URTI, briefTitle: A Study for Assessing the Efficacy and Safety ParActin® in Individuals With Upper Respiratory Tract Infections, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-05-15, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-04-09, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: Vedic Lifesciences Pvt. Ltd., class: INDUSTRY, descriptionModule briefSummary: 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, conditionsModule conditions: Upper Respiratory Tract Infections, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A Double-blind, Randomized, Placebo-Controlled, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule, interventions name: MCC: 400 mg (± 10%) per Capsule, outcomesModule primaryOutcomes measure: To evaluate the effect of investigational products on participant's severity of common cold like symptoms, secondaryOutcomes measure: To evaluate the effect of investigational products on Time (in days) taken to resolution of common cold like symptoms, secondaryOutcomes measure: To evaluate the effect of investigational products on Percentage of participants with unresolved common cold symptoms, secondaryOutcomes measure: 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), secondaryOutcomes measure: To evaluate the effect of investigational products on Number of days taken to be afebrile (temp < 100 oF/< 37.7 ºC) in the population with fever (temp ≥100oF or ≥37.7 ºC ) at baseline- as assessed by 10-point visual analogue scale., secondaryOutcomes measure: To evaluate the effect of investigational products on Percentage population with fever during the study., secondaryOutcomes measure: To evaluate the effect of investigational products on Quality of life as assessed by Wisconsin Upper Respiratory Symptom Survey Quality of Life, eligibilityModule sex: ALL, minimumAge: 16 Years, maximumAge: 50 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Biswas health care & Diagnostic Centre, city: Nainital, state: Uttaranchal, country: India, contacts name: Dr Bijay Biswas, MBBS,MD, role: CONTACT, phone: 919760010003, email: biswasclinic058@gmail.com, geoPoint lat: 29.39743, lon: 79.44686, hasResults: False