NCT06355661

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Vedic Lifesciences Pvt. Ltd. · Industry
• Sex: All
• Age: 16 Years – 50 Years
• Healthy volunteers: Accepted

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

Conditions

• Upper Respiratory Tract Infections

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule	Two capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner)
DIETARY_SUPPLEMENT	MCC: 400 mg (± 10%) per Capsule	Two capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner)

Timeline

• Start date: 2024-04-05
• Primary completion: 2024-07-15
• Completion: 2024-07-30
• First posted: 2024-04-09
• Last updated: 2024-06-17

Locations

9 sites across 1 country: India