Immune HealthNCT04733924
Efficacy and Tolerability of Sensoril® in Improving Immunity and Thereby Reducing Incidence of Upper Respiratory Tract Infections
A study testing Aqueous extract of roots plus leaves of Withania somnifera 125 mg, Aqueous extract of roots plus leaves of Withania somnifera 250 mg and Microcrystalline Cellulose in people with Immune Health, run by Vedic Lifesciences Pvt. Ltd. at 3 sites in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Immune Health
- What is being tested?
- Aqueous extract of roots plus leaves of Withania somnifera 125 mg, Aqueous extract of roots plus leaves of Withania somnifera 250 mg and Microcrystalline Cellulose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 3 sitesIndia
- Study dates
- 21 Jan 2021to 23 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
- 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
- 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).
- 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.
Trial locations and contacts
3 sites in 1 country.
India3 sites
Dr. Rajesh Kewalramani Clinic
Mumbai, Maharashtra, 40068
Sanjivani Day Care and Ayurved Center,
Pālghar, Maharashtra, 401 305
Care N Cure Multispeciality Hospital
Thane, Maharashtra, 401209
About this study
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
- Being tested
- Aqueous extract of roots plus leaves of Withania somnifera 125 mg, Aqueous extract of roots plus leaves of Withania somnifera 250 mg, Microcrystalline Cellulose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqueous extract of roots plus leaves of Withania somnifera 125 mgOther
One capsule before breakfast for 84 days
Aqueous extract of roots plus leaves of Withania somnifera 250 mgOther
One capsule before breakfast for 84 days
Microcrystalline CelluloseOther
One capsule before breakfast for 84 days
| Study group | Role | What they receive |
|---|---|---|
| Withania somnifera 125 mg | Active comparator | One capsule before breakfast for 84 days Receives: 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 Receives: Other: Aqueous extract of roots plus leaves of Withania somnifera 250 mg |
| Microcrystalline Cellulose | Placebo comparator | One capsule before breakfast for 84 days Receives: Other: Microcrystalline Cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: screening to day 0 and day 57 to day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2021
- Study start21 Jan 2021
- Primary completion29 Apr 2021
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733924
- Sponsor's protocol ID
- NT/200803/SENSORIL/URT
- Status last verified
- Oct 2021
- First submitted
- 21 Jan 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Sensoril® in Improving Immunity and Thereby Reducing Incidence of Upper Respiratory Tract Infections
- ClinicalTrials.gov ID
- NCT04733924
- Acronym / sponsor ID
- NT/200803/SENSORIL/URT
- Conditions
- Immune Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Vedic Lifesciences Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 29 Apr 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Withania somnifera 125 mg | Active comparator | Other: Aqueous extract of roots plus leaves of Withania somnifera 125 mgOne capsule before breakfast for 84 days |
| Withania somnifera 250 mg | Active comparator | Other: Aqueous extract of roots plus leaves of Withania somnifera 250 mgOne capsule before breakfast for 84 days |
| Microcrystalline Cellulose | Placebo comparator | Other: Microcrystalline CelluloseOne capsule before breakfast for 84 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aqueous extract of roots plus leaves of Withania somnifera 125 mgOne capsule before breakfast for 84 days | Other | Withania somnifera 125 mg |
| Aqueous extract of roots plus leaves of Withania somnifera 250 mgOne capsule before breakfast for 84 days | Other | Withania somnifera 250 mg |
| Microcrystalline CelluloseOne capsule before breakfast for 84 days | Other | Microcrystalline Cellulose |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aqueous extract of roots plus leaves of Withania somnifera 125 mg, Aqueous extract of roots plus leaves of Withania somnifera 250 mg and Microcrystalline Cellulose in people with Immune Health, run by Vedic Lifesciences Pvt. Ltd. at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wisconsin Upper Respiratory Symptom Survey-21 (time frame: screening to day 0 and day 57 to day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021.