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

NCT04733924 | Completed

• 1 other identifier: NT/200803/SENSORIL/URT
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 3

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.

Conditions

Immune Health

Outcome Measures

Primary Outcomes (1)

• Wisconsin Upper Respiratory Symptom Survey-21

  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

Study Arms (3)

Withania somnifera 125 mg

ACTIVE COMPARATOR

One capsule before breakfast for 84 days

Other: Aqueous extract of roots plus leaves of Withania somnifera 125 mg

Withania somnifera 250 mg

ACTIVE COMPARATOR

One capsule before breakfast for 84 days

Other: Aqueous extract of roots plus leaves of Withania somnifera 250 mg

Microcrystalline Cellulose

PLACEBO COMPARATOR

One capsule before breakfast for 84 days

Other: Microcrystalline Cellulose

Interventions

Aqueous extract of roots plus leaves of Withania somnifera 125 mg OTHER

One capsule before breakfast for 84 days

Withania somnifera 125 mg

Aqueous extract of roots plus leaves of Withania somnifera 250 mg OTHER

One capsule before breakfast for 84 days

Withania somnifera 250 mg

Microcrystalline Cellulose OTHER

One capsule before breakfast for 84 days

Microcrystalline Cellulose

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females aged ≥18 to ≤ 50 years.
• High susceptibility to URTIs, defined as ≥ 4 URTI episodes within 12 months.
• 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.
• SpO2 ≥ 96% as assessed by fingertip pulse oximetry
• 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.

You may not qualify if:

• History of rhinitis medicamentosa, anatomical nasal obstruction or deformity, nasal reconstructive surgery, etc.
• Clinical signs or Symptoms indicating lower respiratory tract infection.
• 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 not accompanied to other symptoms of URTI
• Unable to abstain from any home-based remedies for common cold such as steam inhalation, decoctions, vapour rub, etc. throughout the study period.
• Presence of uncontrolled type 2 diabetes (Indicated by fasting blood glucose (FBG) ≥126 mg/dL)
• Presence of uncontrolled hypertension (Defined as Systolic Blood Pressure (SBP) ≥ 140 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 90 mm Hg).
• 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
• Unable to abstain from ginger, avocado, soy or other known dietary supplements for common cold throughout the study period.
• Vaccination against influenza or swine flu within 3 months prior to screening.

Sponsors & Collaborators

• Vedic Lifesciences Pvt. Ltd.: lead

Study Sites (3)

Dr. Rajesh Kewalramani Clinic

Mumbai, Maharashtra, 40068, India

Location

Sanjivani Day Care and Ayurved Center,

Pālghar, Maharashtra, 401 305, India

Location

Care N Cure Multispeciality Hospital

Thane, Maharashtra, 401209, India

Location

MeSH Terms

Interventions

microcrystalline cellulose

Study Design

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

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: February 2, 2021
• Study Start: January 21, 2021
• Primary Completion: April 29, 2021
• Study Completion: September 23, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

IN (3)