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A Study to Evaluate the Efficacy of EQ-778 on Upper Respiratory Tract Health Status in Healthy Adults

Primary Purpose

Upper Respiratory Tract Infection

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
EQ-778
Placebo
Sponsored by
Vedic Lifesciences Pvt. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Upper Respiratory Tract Infection

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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: Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine, tobacco or smoking dependence. High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women and 5 or more alcohol containing beverages on any day or 15 or more alcohol containing beverages per week for men. Individuals who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.) Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.

Sites / Locations

  • V S General Hospital, 239, E-Ward, 2nd floor, Trauma Centre, VS General Hospital, PaldiRecruiting
  • Poojan Multispeciality Hospital, Navnidhi Avenue, Shubhash Chowk, Swami Vivekanand Marg, Near, MemnagarRecruiting
  • AIMS Hospital, M.I.D.C., Rd Number 5, Milap Nagar, Dombivli EastRecruiting
  • Shreepad ENT and Head and Neck Hospital, T-3-5, Third Floor, Hare Krishna Plaza Building, Hirawadi Corner, Opp Panchavati Bus DepoRecruiting
  • Dr. Desale's Joint Clinic, 1st Floor, Canada Complex, Above Sagar Sweet, College RoadRecruiting
  • Life Care Hospital, Life Care Hospital, Mumbai-Agra Highway, Lekha NagarRecruiting
  • Dhanwantri HospitalRecruiting
  • Umarji Mother and Child Care Hospital, Balewadi Phata, BanerRecruiting
  • Shatayu, Multispeciality Hospital, Sr no. 275/1, Times Square Building, Bhatewara Nagar, HinjawadiRecruiting
  • Gayatri Hospital, 16, 17, 18, Lavdeep Building, Waliv, Vasai EastRecruiting
  • Care n Cure Multispeciality Hospital, Kamdhenu Society, Achole Road, Nallasopara EastRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

EQ-778

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To evaluate the effect of the IP as compared to placebo
Nasal Viral load as assessed by TRU-PCR analysis
To evaluate the effect of the IP as compared to placebo
Change in participants' URTI symptoms severity as compared to the previous day
To evaluate the effect of the IP as compared to placebo
Change in frequency of current URTI episodes rates as compared to the self-reported historical frequency of URTI in previous 6 months before study begins
To evaluate the effect of the IP as compared to placebo
Percentage of population suffering having one or more episode of URTIs during study.
To evaluate the effect of the IP as compared to placebo
The time taken for resolution of the symptoms of the URTIs by eDiary records
To evaluate the effect of the IP as compared to placebo
Change in quality of life using the WURSS-21 questionnaire (in eDiary, as and when the subject gets an episode - recall period: last 24 hours)
To evaluate the effect of the IP as compared to placebo
Immunity as assessed by the change in salivary IgA from baseline
To evaluate the effect of the IP as compared to placebo
Sleep quality assessed by Pittsburgh Sleep Quality Index
To evaluate the effect of the IP as compared to placebo
Mood as assessed by Visual Analogue Scale (VAS)
To evaluate the effect of the IP as compared to placebo
Stress measured by Perceived Stress Scale (PSS)
To evaluate the effect of the IP as compared to placebo
General fatigue as assessed by Fatigue Severity Scale (FSS)
To evaluate the effect of the IP as compared to placebo
To assess the effect of the IP on the consumption of rescue medication
To evaluate the effect of the IP as compared to placebo
To assess the impact of the intervention on daily routine activities by a VAS scale
To evaluate the effect of the IP as compared to placebo
To assess the impact of the IP on mood, stress, fatigue, sleep quality and physical activity as assessed by a VAS scale

Full Information

First Posted
April 18, 2023
Last Updated
September 4, 2023
Sponsor
Vedic Lifesciences Pvt. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05835375
Brief Title
A Study to Evaluate the Efficacy of EQ-778 on Upper Respiratory Tract Health Status in Healthy Adults
Official Title
A Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy of EQ-778 on Upper Respiratory Tract Health Status in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2023 (Actual)
Primary Completion Date
April 26, 2024 (Anticipated)
Study Completion Date
April 26, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vedic Lifesciences Pvt. Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infection

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, parallel group, double-blind, placebo-controlled trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
374 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EQ-778
Arm Type
Active Comparator
Arm Description
capsule to be taken daily after breakfast (in case no URTI episode) capsules to be taken daily after breakfast (in case of URTI episode)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
capsule to be taken daily after breakfast (in case no URTI episode) capsules to be taken daily after breakfast (in case of URTI episode)
Intervention Type
Other
Intervention Name(s)
EQ-778
Intervention Description
capsule daily after breakfast (in case of no URTI episode); capsules after breakfast (in case of URTI episode)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
capsule daily after breakfast (in case of no URTI episode); capsules after breakfast (in case of URTI episode)
Primary Outcome Measure Information:
Title
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.
Time Frame
180 Days
Secondary Outcome Measure Information:
Title
To evaluate the effect of the IP as compared to placebo
Description
Nasal Viral load as assessed by TRU-PCR analysis
Time Frame
During episodes of URTI throughout the study
Title
To evaluate the effect of the IP as compared to placebo
Description
Change in participants' URTI symptoms severity as compared to the previous day
Time Frame
On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
Title
To evaluate the effect of the IP as compared to placebo
Description
Change in frequency of current URTI episodes rates as compared to the self-reported historical frequency of URTI in previous 6 months before study begins
Time Frame
On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
Title
To evaluate the effect of the IP as compared to placebo
Description
Percentage of population suffering having one or more episode of URTIs during study.
Time Frame
On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
Title
To evaluate the effect of the IP as compared to placebo
Description
The time taken for resolution of the symptoms of the URTIs by eDiary records
Time Frame
On every visit (Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180)
Title
To evaluate the effect of the IP as compared to placebo
Description
Change in quality of life using the WURSS-21 questionnaire (in eDiary, as and when the subject gets an episode - recall period: last 24 hours)
Time Frame
Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, and Day 180
Title
To evaluate the effect of the IP as compared to placebo
Description
Immunity as assessed by the change in salivary IgA from baseline
Time Frame
Day 0 and Day 180
Title
To evaluate the effect of the IP as compared to placebo
Description
Sleep quality assessed by Pittsburgh Sleep Quality Index
Time Frame
Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
Title
To evaluate the effect of the IP as compared to placebo
Description
Mood as assessed by Visual Analogue Scale (VAS)
Time Frame
Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
Title
To evaluate the effect of the IP as compared to placebo
Description
Stress measured by Perceived Stress Scale (PSS)
Time Frame
Day 0, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180 and during each URTI episode
Title
To evaluate the effect of the IP as compared to placebo
Description
General fatigue as assessed by Fatigue Severity Scale (FSS)
Time Frame
Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
Title
To evaluate the effect of the IP as compared to placebo
Description
To assess the effect of the IP on the consumption of rescue medication
Time Frame
Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
Title
To evaluate the effect of the IP as compared to placebo
Description
To assess the impact of the intervention on daily routine activities by a VAS scale
Time Frame
Day 0, Day 30, Day 60, Day 90, Day 120, Day 150 and Day 180
Title
To evaluate the effect of the IP as compared to placebo
Description
To assess the impact of the IP on mood, stress, fatigue, sleep quality and physical activity as assessed by a VAS scale
Time Frame
On the last day of the URTI episode.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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: Use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/Nicotine, tobacco or smoking dependence. High-risk drinking as defined by consumption of 4 or more alcohol containing beverages on any day or 8 or more alcohol containing beverages per week for women and 5 or more alcohol containing beverages on any day or 15 or more alcohol containing beverages per week for men. Individuals who have clinically significant following severe illness (i.e., Cardiovascular, endocrine system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, neuropsychiatric, musculoskeletal, inflammatory, blood and tumors, gastrointestinal diseases, etc.) Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives. Any condition that could, in the opinion of the investigator, preclude the participant's ability to successfully and safely complete the study or that may confound study outcomes.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Shalini Srivastava, MBBS, MD
Phone
42172300
Ext
022
Email
shalini.s@vediclifesciences.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dr. Sonal Raote, BAMS
Phone
42172300
Ext
022
Email
sonal.raote@vediclifesciences.com
Facility Information:
Facility Name
V S General Hospital, 239, E-Ward, 2nd floor, Trauma Centre, VS General Hospital, Paldi
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380006
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Dhaiwat Shukla, MBBS, MD
Phone
8980024107
Ext
+91
Email
dr.dhaiwatshukla89@gmail.com
Facility Name
Poojan Multispeciality Hospital, Navnidhi Avenue, Shubhash Chowk, Swami Vivekanand Marg, Near, Memnagar
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380052
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Ronak Shah, MBBS, MD
Phone
9924656600
Ext
+91
Email
poojan.research@gmail.com
Facility Name
AIMS Hospital, M.I.D.C., Rd Number 5, Milap Nagar, Dombivli East
City
Dombivli
State/Province
Maharashtra
ZIP/Postal Code
421203
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Sandeep Kadian, MBBS, MD
Phone
9870364574
Ext
+91
Email
drsandeepkadian@rediffmail.com
Facility Name
Shreepad ENT and Head and Neck Hospital, T-3-5, Third Floor, Hare Krishna Plaza Building, Hirawadi Corner, Opp Panchavati Bus Depo
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422003
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Maheshkumar Nikam, MBBS, MS
Phone
8805556996
Ext
+91
Email
drmaheshnikam211@gmail.com
Facility Name
Dr. Desale's Joint Clinic, 1st Floor, Canada Complex, Above Sagar Sweet, College Road
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422005
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Namrata Modi, MBBS, DNB
Phone
7045103821
Ext
+91
Email
namratamodi11@gmail.com
Facility Name
Life Care Hospital, Life Care Hospital, Mumbai-Agra Highway, Lekha Nagar
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422009
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Sandeep Gaidhani, MBBS, MD
Phone
7588606598
Ext
+91
Email
drsandeepgaidhani@gmail.com
Facility Name
Dhanwantri Hospital
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411011
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Bharat Jain, MBBS, DNB
Phone
8087448919
Email
dr_bharatjain@rediffmail.com
Facility Name
Umarji Mother and Child Care Hospital, Balewadi Phata, Baner
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411045
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Pramod Umarji, MBBS, MD
Phone
9822307068
Ext
+91
Email
pramod.umarji@gmail.com
Facility Name
Shatayu, Multispeciality Hospital, Sr no. 275/1, Times Square Building, Bhatewara Nagar, Hinjawadi
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411057
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Sachin Shivnitwar
Phone
8999285166
Ext
+91
Email
drsachinshivnitwar044@gmail.com
Facility Name
Gayatri Hospital, 16, 17, 18, Lavdeep Building, Waliv, Vasai East
City
Vasai
State/Province
Maharashtra
ZIP/Postal Code
401208
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Ashok Jangid, BAMS, MD
Phone
8286163751
Email
ashokbjangid@gmail.com
Facility Name
Care n Cure Multispeciality Hospital, Kamdhenu Society, Achole Road, Nallasopara East
City
Virār
State/Province
Maharashtra
ZIP/Postal Code
401209
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Chandrakant Mishra, BAMS
Phone
8888444609
Ext
+91
Email
dr.chandrakant89@gmail.com

12. IPD Sharing Statement

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A Study to Evaluate the Efficacy of EQ-778 on Upper Respiratory Tract Health Status in Healthy Adults

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