None listed
Conditions
Interventions
Intervention1: LN20189 500 mg/Day: One capsule to be taken daily in the morning after breakfast for 28 days
Control Intervention1: Placebo: One capsule to be taken daily in the morning after breakfas
Sponsors
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1)Healthy male and female subjects aged between 35-60 years with body mass index (BMI) of 22-29.9 kg/m2. 2)Healthy subjects with self-reported or history of non-specific clinical symptoms like, fatigue, weakness, malaise, recurrent attacks of cold/allergies, running nose, fever (not within 03 days prior to screening or randomization visit). 3)Subject agrees to maintain diet tracker. 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
Exclusion criteria: 1)Subjects on special diets, probiotics, taking nutritional supplements or medications known to affect immune function or absorption of nutrients. 2)Subjects with uncontrolled diabetes (FBS >125mg/dL), hypertension (Systolic >145 and Diastolic >90 mmHg). 3)Subjects underwent treatment for COVID 19 or tested positive during the study will be excluded. 4)Subjects using Immune modifying medications ( Anti-inflammatory agents, antibiotics, anti-histamines, etc.- for last one month, Steroids- for last 03 months). 5)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, Crohnâ??s Disease, Dermatomyositis, Fibromyalgia, Graveâ??s Disease, Hashimotoâ??s Thyroiditis, Lupus, Myasthenia Gravis, Pernicious Anemia, Polyarteritis Nodosa, Primary Biliary Cirrhosis, Psoriasis, Reynaudâ??s Disease, Rheumatoid Arthritis, Sarcoidosis, Scleroderma, Sjogrenâ??s Syndrome, Temporal Arthritis, Guillain-Barré Syndrome, Inflammatory Bowel Disease, Ulcerative Colitis, and Vitiligo. 6)Subjects who used immunosuppressive drugs in the last 6 months. 7)Subjects who undergo regular chemotherapy or radiation therapy for different cancers. 8)Any health drinks, vitamin supplements or immune boosters (within 4 weeks) deemed likely to interfere with the evaluation (e.g., other herbal or Nutraceutical products). 9)Subjects with COPD, asthma, any respiratory or breathing related disorders. 10)Subjects who consume alcohol ( >5 drinks per week), habit of smoking, chewing tobacco, use of recreational drugs (such as cocaine, methamphetamine, marijuana etc.). 11)Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies. 12)Subjects with HIV Positive. 13)Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study. 14)Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 15)Any other condition that, in the opinion of the investigator, would adversely affect the subjectâ??s ability to complete the study or its measures. 16)Subjects who have participated or currently participating in another clinical trial within 30 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: T-cell population Timepoint: Day 1 and 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in: T cell subsets NK cell count Serum markers Hematological parameters Immune function questionnaire (IFQ)Timepoint: Day 1 and 28 | — |
Countries
India
Contacts
Public ContactMr Prason Kumar
Laila Nutraceuticals
Outcome results
None listed