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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04733924
Recruitment Status : Completed
First Posted : February 2, 2021
Last Update Posted : October 19, 2021
Sponsor:
Information provided by (Responsible Party):
Vedic Lifesciences Pvt. Ltd.

Tracking Information
First Submitted Date  ICMJE January 21, 2021
First Posted Date  ICMJE February 2, 2021
Last Update Posted Date October 19, 2021
Actual Study Start Date  ICMJE January 21, 2021
Actual Primary Completion Date April 29, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2021)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2021)
Wisconsin Upper Respiratory Symptom Survey-21 [ Time Frame: Day 0 - day 85 ]
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).
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerability of Sensoril® in Improving Immunity and Thereby Reducing Incidence of Upper Respiratory Tract Infections
Official Title  ICMJE Efficacy and Tolerability of Sensoril® in Improving Immunity and Thereby Reducing Incidence of Upper Respiratory Tract Infections
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Immune Health
Intervention  ICMJE
  • Other: Aqueous extract of roots plus leaves of Withania somnifera 125 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
  • Other: Microcrystalline Cellulose
    One capsule before breakfast for 84 days
Study Arms  ICMJE
  • Active Comparator: Withania somnifera 125 mg
    One capsule before breakfast for 84 days
    Intervention: Other: Aqueous extract of roots plus leaves of Withania somnifera 125 mg
  • Active Comparator: Withania somnifera 250 mg
    One capsule before breakfast for 84 days
    Intervention: Other: Aqueous extract of roots plus leaves of Withania somnifera 250 mg
  • Placebo Comparator: Microcrystalline Cellulose
    One capsule before breakfast for 84 days
    Intervention: Other: Microcrystalline Cellulose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 30, 2021)
77
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 23, 2021
Actual Primary Completion Date April 29, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04733924
Other Study ID Numbers  ICMJE NT/200803/SENSORIL/URT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Vedic Lifesciences Pvt. Ltd.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vedic Lifesciences Pvt. Ltd.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Vedic Lifesciences Pvt. Ltd.
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP