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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Withania somnifera 125 mg | Active Comparator | One capsule before breakfast for 84 days |
|
| Withania somnifera 250 mg | Active Comparator | One capsule before breakfast for 84 days |
|
| Microcrystalline Cellulose | Placebo Comparator | One capsule before breakfast for 84 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aqueous extract of roots plus leaves of Withania somnifera 125 mg | Other | One capsule before breakfast for 84 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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:
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.
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.
History of any significant neurological and psychiatric condition which may affect the participation and inference of the study's end points.
Individuals having a history (in past 2 years) of smoking or currently smoking or using any form of smokeless tobacco.
Participation in other clinical trials in last 90 days prior to screening
Participants with heavy alcohol consumption, defined as
Binge drinkers, defined as 4 or more SAD for women, and 5 or more SAD for men, in a 2-hour time frame.
History or presence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
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.)
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr. Rajesh Kewalramani Clinic | Mumbai | Maharashtra | 40068 | India | ||
| Sanjivani Day Care and Ayurved Center, |
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| Aqueous extract of roots plus leaves of Withania somnifera 250 mg | Other | One capsule before breakfast for 84 days |
|
| Microcrystalline Cellulose | Other | One capsule before breakfast for 84 days |
|
| Pālghar |
| Maharashtra |
| 401 305 |
| India |
| Care N Cure Multispeciality Hospital | Thane | Maharashtra | 401209 | India |
| ID | Term |
|---|---|
| C109691 | microcrystalline cellulose |
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