A randomized, double-blind, placebo-controlled clinical study to evaluate the effect of LN20189 on Immune function in healthy subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Laila Nutraceuticals
- Enrollment
- 120
- Locations
- 3
- Primary Endpoint
- Change from baseline to the end of the study period in:
Study Overview
Brief Summary
The purpose of this study is to assess the efficacy of LN20189 on immune function in healthy subjects. A total of 120 male and female subjects of age between 30 and 60 years will be included in the study. Assessment of inclusion and exclusion criteria will be done based on clinical and laboratory investigations. The eligible subjects will be randomized as per the computer generated randomization list. The subjects will be assigned to either one of the three study groups (LN20189 250 mg or LN20189 500 mg or Placebo) at 1:1:1 ratio. The participants will be instructed to take one capsule daily in the morning after breakfast for 84 days. The outcome measures include Daily completion of Wisconsin upper respiratory symptom survey (WURSS-24), Psychological general wellbeing index (PGWBI), Immune cell population (T cells, CD4 T cells, CD8 T cells, B cells and NK cells), Total WBC count, differential count and serum biomarkers(IFN-gamma, IL-4, IgG and TAC). Besides, the study will also record the vital signs and adverse events to evaluate the herbal composition’s safety and tolerability. The safety assessment of LN20189 will also include the routine laboratory investigations on blood, urine and clinical chemistry at screening and the final visit of the intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 30.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Male and female subjects aged between 30-60 years with body mass index (BMI) of 22-29.9 kg per meter square.
- •2.Healthy subjects with reduced perceived Immune status (as assessed by Immune status questionnaire (ISQ) score of<6).
- •3.Subject agrees to maintain diet and activity levels.
- •4.Subject considered generally healthy as per health history and routine clinical investigations during screening.
- •5.Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-Provera®, or double-barrier and have a negative pregnancy test at the screening visit.
- •6.Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.
Exclusion Criteria
- •1.Subjects with history or condition that caused nasal obstruction such as nasal polyps, nasal/sinus surgery and other nasal structural problems.
- •2.Subjects underwent treatment for COVID-19 within last 3 months or tested positive during the study will be excluded.
- •3.Subjects who are taking medication for diabetes or hypertension; Subjects with FBS>125mg/dL or Systolic BP>145 or Diastolic BP>90 mmHg. 4.Subjects using Immune modifying medications (Anti-inflammatory agents, antibiotics, anti-histamines, etc.
- •for last one month, Steroids- for last 03 months).
- •5.Subjects who are zinc deficient or on special diets, probiotics, taking nutritional supplements or medications known to affect immune function or absorption of nutrients.
- •6.Subjects with any history of immune system disorder or auto-immune disorder including but not limited to the following : AIDS, Ankylosing Spondylitis, Chronic Fatigue Syndrome, CREST Syndrome, Crohn’s Disease, Dermatomyositis, Fibromyalgia, Grave’s Disease, Hashimoto’s Thyroiditis, Lupus, Myasthenia Gravis, Pernicious Anemia, Polyarteritis Nodosa, Primary Biliary Cirrhosis, Psoriasis, Reynaud’s Disease, Rheumatoid Arthritis, Sarcoidosis, Scleroderma, Sjogren’s Syndrome, Temporal Arthritis, Guillain-Barré Syndrome, Inflammatory Bowel Disease, Ulcerative Colitis, and Vitiligo.
- •7.Any health drinks, vitamin supplements or immune boosters (within 4 weeks) or nasal device/sprays deemed likely to interfere with the evaluation (e.g., other herbal or Nutraceutical products).
- •8.Subjects who used immunosuppressive drugs in the last 6 months.
- •9.Subjects with COPD, asthma, any respiratory or breathing related disorders.
- •10.Subjects who consume alcohol (>5 drinks per week), habit of smoking (>3 Cigarettes per day), chewing tobacco, or use of recreational drugs (such as cocaine, methamphetamine, marijuana etc.).
- •12.Female subjects, who are pregnant, lactating or planning to become pregnant during the study.
- •13.Subjects with history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
- •14.Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures.
- •15.Subjects with known allergy or intolerance to any of study ingredients.
- •16.Subjects who have participated or currently participating in another clinical trial within 30 days prior to screening.
Outcomes
Primary Outcomes
Change from baseline to the end of the study period in:
Time Frame: Day 1, Day 21, Day 42 and Day 84
Daily completion of Wisconsin Upper Respiratory Symptom Survey (WURSS-24)
Time Frame: Day 1, Day 21, Day 42 and Day 84
Secondary Outcomes
- Change from baseline to the end of the study period in:(Serum biomarkers (IFN-gamma, IL-4, IgG and TAC))