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

NCT06355661 | Recruiting DMC

• 1 other identifier: HP/231102/PA/URTI
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 9

Brief 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

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of investigational products on participant's severity of common cold like symptoms

  evaluated by Wisconsin Upper Respiratory Symptom Survey-21 total severity score (incremental Area Under the Curve (iAUC) The WURSS-21 consists of ten symptom-specific items which includes runny nose, plugged nose, sneezing, sore throat, scratchy throat, cough, hoarseness, head congestion, chest congestion, and feeling tired.

  During Upper respiratory tract infection episodes throughout the study upto 7 day Treatment duration

Secondary Outcomes (6)

• To evaluate the effect of investigational products on Time (in days) taken to resolution of common cold like symptoms

  During episodes of URTI upto 7 day Treatment duration

• To evaluate the effect of investigational products on Percentage of participants with unresolved common cold symptoms

  During episodes of URTI upto 7 day Treatment duration

• 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)

  During episodes of URTI upto 7 day Treatment duration

• 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.

  During episodes of URTI upto 7 day Treatment duration

• To evaluate the effect of investigational products on Percentage population with fever during the study.

  During episodes of URTI upto 7 day Treatment duration

Study Arms (2)

ParActin®: 300 mg + MCC: 100 mg (± 10%)

ACTIVE COMPARATOR

Two capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner).

Dietary Supplement: ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule

MCC: 400 mg (± 10%) per Capsule

PLACEBO COMPARATOR

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

Interventions

ParActin®: 300 mg + MCC: 100 mg (± 10%) per Capsule DIETARY_SUPPLEMENT

Two capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner)

ParActin®: 300 mg + MCC: 100 mg (± 10%)

MCC: 400 mg (± 10%) per Capsule DIETARY_SUPPLEMENT

Two capsules/day (One capsule to be taken 30 minutes before breakfast \& one capsule to be taken 30 minutes before dinner)

MCC: 400 mg (± 10%) per Capsule

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and female aged between 18 and 50 years as of the screening date.
• Individuals with symptoms of acute upper respiratory tract infection as assessed by the investigator at the time of screening.
• BMI ≤ 29.9 kg/m2.
• Upper respiratory tract infection symptoms present for at least 24 hours but not more than 48 hours prior to screening visit.
• 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.
• History of frequent common cold with past episode duration of at least 4 days.
• Must be literate and have the ability to complete the study-based questionnaires and requirements.

You may not qualify if:

• High grade fever defined as body temperature ≥ 39ºC (≥ 102.2 ºF)
• With a history of allergy (allergic rhinitis) along with symptoms such as sneezing, runny nose and red, watery and itchy eyes.
• Individuals with history of Chronic obstructive pulmonary disease, pulmonary fibrosis or Asthma.
• Individuals with rhinitis medicamentosa, chronic cough of bacterial, fungal or other known origin.
• Individuals requiring hospitalization or likely to be hospitalised due to URTI.
• Individuals with common cold for the first time.
• Individuals with anatomical nasal obstruction/ deformity or nasal reconstructive surgery etc.
• Individuals with history of heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
• Individuals with history of immunocompromised state immune system with/ without organ transplant
• Individuals with known or suspected hypersensitivity or intolerance to herbal products
• Individuals diagnosed with Sickle cell disease, Thalassemia, Type I/ II Diabetes mellitus, Cystic fibrosis
• Diagnosed cases of Uncontrolled hypertension as assessed by a systolic blood pressure ≥ to 140mmHg and diastolic blood pressure ≥ to 90mmHg
• 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.
• 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.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (9)

Life care hospital

Nashik, Maharashtra, 422009, India

RECRUITING

ENT Vertigo Clinic

Pune, Maharashtra, 411045, India

RECRUITING

Jawaharlal Nehru Medical College

Ajmer, Rajasthan, 305001, India

RECRUITING

Human Care Hospital

Lucknow, Uttar Pradesh, 226012, India

RECRUITING

Shubham Sudbhawana Super Speciality Hospital

Varanasi, Uttar Pradesh, 221005, India

RECRUITING

Janta Hospital

Varanasi, Uttar Pradesh, 221011, India

NOT YET RECRUITING

Gastron Clinic

Delhi, 110015., India

RECRUITING

Good health Clinic

Delhi, 110027, India

RECRUITING

Tulsi Multispecility Hospital

Delhi, 110094, India

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Central Study Contacts

Dr. Shalini Srivastava, MBBS, MD

CONTACT

9920789140; shalini.s@vediclifesciences.com

Dr Sonal Raote, BAMS

CONTACT

02242172325; sonal.raote@vediclifesciences.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Double-blind, Randomized, Placebo-Controlled

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 9, 2024
• Study Start: April 5, 2024
• Primary Completion: July 15, 2024
• Study Completion: July 30, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (9)