Efficacy and Tolerability of Sensoril® in Improving Immunity and Thereby Reducing Incidence of Upper Respiratory Tract Infections

October 18, 2021 updated by: Vedic Lifesciences Pvt. Ltd.
to assess the efficacy and safety of a standardized Withania somnifera extract (Sensoril®) as an immunomodulator in individuals suffering from recurrent URTIs. The study population will be administered with this unique blend of WS extract for 12 weeks and will be assessed as per the study designated efficacy and safety variables.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Maharashtra
      • Mumbai, Maharashtra, India, 40068
        • Dr. Rajesh Kewalramani Clinic
      • Palghar, Maharashtra, India, 401 305
        • Sanjivani Day Care and Ayurved Center,
      • Thāne, Maharashtra, India, 401209
        • Care n Cure Multispeciality Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and females aged ≥18 to ≤ 50 years.
  2. High susceptibility to URTIs, defined as ≥ 4 URTI episodes within 12 months.
  3. Presence of an active URTI episode (Defined as a score of ≥5 for atleast 2 of following 6 symptoms: runny nose, plugged nose, sneezing, sore throat, scratchy throat, or cough on the WURSS-21 assessment), with onset of symptoms within 48 hours prior to screening.
  4. SpO2 ≥ 96% as assessed by fingertip pulse oximetry
  5. Commitment to adhere to former diet and physical activities throughout the study period. 6. Able to comply and perform the procedures requested by the protocol (consumption of study medications, filling daily eDiary for health updates, biological sample collection procedures and study visit schedule) 7. Participants who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights. 8. Participants who are able to give written informed consent and are willing to participate in the study.

Exclusion Criteria:

  1. History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, etc.
  2. Clinical signs or Symptoms indicating lower respiratory tract infection.
  3. Known sensitivity to the investigational product or any excipients of the drug product.
  4. Any clinically significant abnormalities of the upper respiratory tract (such as stridor, laryngomalacia, etc.)
  5. Any clinically significant acute or chronic respiratory illness (such as Sinusitis, pharyngitis/tonsillitis, etc.)
  6. Chronic cough of any origin not accompanied to other symptoms of URTI
  7. Unable to abstain from any home-based remedies for common cold such as steam inhalation, decoctions, vapour rub, etc. throughout the study period.
  8. Presence of uncontrolled type 2 diabetes (Indicated by fasting blood glucose (FBG) ≥126 mg/dL)
  9. Presence of uncontrolled hypertension (Defined as Systolic Blood Pressure (SBP) ≥ 140 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 90 mm Hg).

  10. Participants with abnormal liver and kidney function tests, defined as:

    • Serum aspartate aminotransferase (AST) and alanine transaminase (ALT) levels > 1.5 × upper level of normal
    • Serum alkaline phosphatase (ALP) levels > 1.5 × upper level of normal
    • Serum creatinine levels > 1.5 × upper level of normal
  11. Unable to abstain from ginger, avocado, soy or other known dietary supplements for common cold throughout the study period.
  12. Vaccination against influenza or swine flu within 3 months prior to screening.
  13. Those who have taken or will be taking or are taking antibiotics, antivirals, steroids, nasal decongestants, antihistamines, or other medications that are expected to alleviate cold symptoms within two weeks prior to randomization.
  14. History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
  15. Individuals having a history (in past 2 years) of smoking or currently smoking or using any form of smokeless tobacco.
  16. Participation in other clinical trials in last 90 days prior to screening

  17. Participants with heavy alcohol consumption, defined as

    • For men: More than 14 standard alcoholic drink (SAD)/week or more than 4 SAD in a day.
    • For women: More than 7 SAD/week or more than 3 SAD in a day. (NOTE - A standard alcoholic drink contains approximately 14 grams of alcohol, which is equivalent to 12 ounces of beer (~5% alcohol), 8.5 ounces of malt liquor (~9% alcohol), 5 ounces of wine (~12% alcohol), 3.5 ounces of fortified wine (e.g., sherry or port), or 1.5 ounces of liquor (distilled spirits; ~40% alcohol).
  18. Binge drinkers, defined as 4 or more SAD for women, and 5 or more SAD for men, in a 2-hour time frame.
  19. History or presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
  20. Participants 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.)
  21. Females who are pregnant/planning to be pregnant/lactating or taking any oral contraceptives.
  22. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Withania somnifera 125 mg
One capsule before breakfast for 84 days
Other: Aqueous extract of roots plus leaves of Withania somnifera 125 mg
One capsule before breakfast for 84 days
ACTIVE_COMPARATOR: Withania somnifera 250 mg
One capsule before breakfast for 84 days
Other: Aqueous extract of roots plus leaves of Withania somnifera 250 mg
One capsule before breakfast for 84 days
PLACEBO_COMPARATOR: Microcrystalline Cellulose
One capsule before breakfast for 84 days
Other: Microcrystalline Cellulose
One capsule before breakfast for 84 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Wisconsin Upper Respiratory Symptom Survey-21
Time Frame: screening to day 0 and day 57 to day 84
the effect of IP consumption on incidence of upper respiratory tract infection (URTI) episodes till day 28, 56, and 85 in comparison to placebo as assessed by Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21).
screening to day 0 and day 57 to day 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vedic Lifesciences Pvt. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 23, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NT/200803/SENSORIL/URT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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