NCT05835375

Brief Summary

This study is a randomized, double-blind, Placebo Controlled study to evaluate the efficacy of 180 days administration of EQ-778 on upper respiratory tract health status in healthy adults

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
374

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

13 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

August 2, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2024

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

9 months

First QC Date

April 18, 2023

Last Update Submit

January 30, 2024

Conditions

Upper Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

  • To assess effect of administration of IP on the severity of Upper respiratory tract infections (URTI) symptoms as assessed by area under curve (AUC) for Wisconsin Upper Respiratory Symptom Survey - 21 (WURSS-21) symptom severity score.

    180 Days

Secondary Outcomes (14)

  • To evaluate the effect of the IP as compared to placebo

    During episodes of URTI throughout the study

  • To evaluate the effect of the IP as compared to placebo

    On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)

  • To evaluate the effect of the IP as compared to placebo

    On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)

  • To evaluate the effect of the IP as compared to placebo

    On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)

  • To evaluate the effect of the IP as compared to placebo

    On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)

  • +9 more secondary outcomes

Study Arms (2)

EQ-778

ACTIVE COMPARATOR

1. capsule to be taken daily after breakfast (in case no URTI episode) 2. capsules to be taken daily after breakfast (in case of URTI episode)

Other: EQ-778

Placebo

PLACEBO COMPARATOR

1. capsule to be taken daily after breakfast (in case no URTI episode) 2. capsules to be taken daily after breakfast (in case of URTI episode)

Other: Placebo

Interventions

EQ-778OTHER

1. capsule daily after breakfast (in case of no URTI episode); 2. capsules after breakfast (in case of URTI episode)

EQ-778
PlaceboOTHER

1. capsule daily after breakfast (in case of no URTI episode); 2. capsules after breakfast (in case of URTI episode)

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male and female individuals ≥ 18 and ≤ 50 years' old with moderate physical activity level as per International Physical Activity Questionnaire - Short Form (IPAQ - SF)
  • BMI ≥ 18.5 and ≤ 34.9 kg/m2
  • High susceptibility to URTIs (≥ 3 and ≤ 6 episodes within 12 months)
  • Commitment to adhere to routine diet and physical activity.
  • Willing to consume IP or placebo, complete questionnaires, records, etc., associated with the study and to complete all clinical study visits.

You may not qualify if:

  • History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, etc.
  • Known sensitivity to the investigational product or any excipients of the drug product.
  • Any clinically significant abnormalities of the upper respiratory tract (such as stridor, laryngomalacia, etc)
  • Any clinically significant acute or chronic respiratory illness (such as Sinusitis, pharyngitis/tonsillitis, etc)
  • Chronic cough of any origin
  • Any individual not willing to follow the abstinence from any home-based remedies for common cold such as steam inhalation, decoctions, vapour rub, etc.
  • Individuals with uncontrolled type 2 diabetes as assessed by fasting blood glucose ≥ 126 mg/dL
  • Individuals with uncontrolled hypertension on medication and with systolic blood pressure ≥160 and/or diastolic blood pressure ≥100 mm Hg will be excluded.
  • Unable to abstain from herbal or dietary supplements for URTI throughout the study period.
  • Vaccination against influenza or swine flu within 3 months prior to screening.
  • Individuals with COVID infection in the last 30 days
  • Those who have taken or should be taking or are taking antibiotics, antivirals, steroids, nasal decongestants, antihistamines, NSAIDS (paracetamol) or other medications that are expected to alleviate cold symptoms within two weeks prior to screening.
  • History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
  • Participation in other clinical trials in last 30 days prior to screening
  • Individuals with substance abuse problems (within 2 years) defined as:
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

V S General Hospital, 239, E-Ward, 2nd floor, Trauma Centre, VS General Hospital, Paldi

Ahmedabad, Gujarat, 380006, India

RECRUITING

Poojan Multispeciality Hospital, Navnidhi Avenue, Shubhash Chowk, Swami Vivekanand Marg, Near, Memnagar

Ahmedabad, Gujarat, 380052, India

RECRUITING

AIMS Hospital, M.I.D.C., Rd Number 5, Milap Nagar, Dombivli East

Dombivali, Maharashtra, 421203, India

RECRUITING

Shreepad ENT and Head and Neck Hospital, T-3-5, Third Floor, Hare Krishna Plaza Building, Hirawadi Corner, Opp Panchavati Bus Depo

Nashik, Maharashtra, 422003, India

RECRUITING

Dr. Desale's Joint Clinic, 1st Floor, Canada Complex, Above Sagar Sweet, College Road

Nashik, Maharashtra, 422005, India

RECRUITING

Life Care Hospital, Life Care Hospital, Mumbai-Agra Highway, Lekha Nagar

Nashik, Maharashtra, 422009, India

RECRUITING

Dhanwantri Hospital

Pune, Maharashtra, 411011, India

RECRUITING

Umarji Mother and Child Care Hospital, Balewadi Phata, Baner

Pune, Maharashtra, 411045, India

RECRUITING

Shatayu, Multispeciality Hospital, Sr no. 275/1, Times Square Building, Bhatewara Nagar, Hinjawadi

Pune, Maharashtra, 411057, India

RECRUITING

Gayatri Hospital, 16, 17, 18, Lavdeep Building, Waliv, Vasai East

Vasai, Maharashtra, 401208, India

RECRUITING

Care n Cure Multispeciality Hospital, Kamdhenu Society, Achole Road, Nallasopara East

Virār, Maharashtra, 401209, India

RECRUITING

Janta Hospital & Maternity Centre

Varanasi, Uttar Pradesh, 221011, India

RECRUITING

Tulsi Hospital

Delhi, 110094., India

RECRUITING

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Central Study Contacts

Dr. Shalini Srivastava, MBBS, MD

CONTACT

42172300shalini.s@vediclifesciences.com

Dr. Sonal Raote, BAMS

CONTACT

42172300sonal.raote@vediclifesciences.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized, parallel group, double-blind, placebo-controlled trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2023

First Posted

April 28, 2023

Study Start

August 2, 2023

Primary Completion

April 26, 2024

Study Completion

April 26, 2024

Last Updated

January 31, 2024

Record last verified: 2024-01

Locations

IN(13)