None listed
Conditions
Interventions
Intervention1: Alviolife 200 mg: One capsule (200 mg) daily in the
morning after breakfast for 42
days
Intervention2: Alviolife Plus 400 mg: One capsule (400 mg) daily in the morning after breakfast f
Sponsors
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: ââ?¬Â¢ Healthy male and female subjects aged between 20-65 years with body mass index (BMI) of 22 ââ?¬â?? 29.9 kg/m2. ââ?¬Â¢ Healthy subjects with self-reported sensitivity (with symptoms include nasal congestion, sore throat, oro-larangeal or nasal itchiness, cough, Hoarse voice, etc.) to air pollution. ââ?¬Â¢ Subjects willing to walk for 6 minutes as per the study procedure. ââ?¬Â¢ Subject agrees to maintain a diet tracker. ââ?¬Â¢ Subject considered generally healthy as per health history and routine clinical investigations during screening. ââ?¬Â¢ Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month before screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, Depo-ProveraÃ?®, or double-barrier and have a negative pregnancy test at the screening visit. ââ?¬Â¢ Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.
Exclusion criteria
Exclusion criteria: ââ?¬Â¢ Subjects suffering from or with a history of chronic respiratory disorders such as Asthma, chronic obstructive pulmonary disorders (COPD), bronchitis, etc. ââ?¬Â¢ Use of any vitamin supplements or multivitamin ââ?¬Â¢ Subjects with the habit of chewing tobacco, or smoking ââ?¬Â¢ Subjects with a history of thyroid dysfunction ââ?¬Â¢ Subjects underwent treatment for COVID 19 ââ?¬Â¢ Subjects with current treatment for CVD, heart attack or stroke. ââ?¬Â¢ Immune modifying medications ( Anti-inflammatory agents, Antibiotics, anti-histaminics, etc.- for last one month, Steroids- for last 03 months) ââ?¬Â¢ 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, Crohnââ?¬•s Disease, Dermatomyositis, Fibromyalgia, Graveââ?¬•s Disease, Hashimotoââ?¬•s Thyroiditis, Lupus, Myasthenia Gravis, Pernicious Anemia, Polyarteritis Nodosa, Primary Biliary Cirrhosis, Psoriasis, Reynaudââ?¬•s Disease, Rheumatoid Arthritis, Sarcoidosis, Scleroderma, Sjogrenââ?¬•s Syndrome, Temporal Arthritis, Ulcerative Colitis, and Vitiligo. ââ?¬Â¢ Subjects who used immunosuppressive drugs in the last 5 years. ââ?¬Â¢ Subjects with Diabetes or Hypertension. ââ?¬Â¢ Liver function tests > 2 X upper limit of normal (ULN) and/or Creatinine > 1.5 ULN ââ?¬Â¢ Alcohol intake >2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.) ââ?¬Â¢ Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic neurologic diseases, malignancies ââ?¬Â¢ Female subjects who are pregnant, breast feeding or planning to become pregnant during the study. ââ?¬Â¢ Subjects having a history of psychiatric disorder that may impair the ability of subjects to provide written informed consent. ââ?¬Â¢ Any other condition that, in the opinion of the investigator, would adversely affect the subjectââ?¬•s ability to complete the study or its measures. ââ?¬Â¢ Use of other nutritional supplements within 30 days prior to the study. ââ?¬Â¢ Subjects who 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 Respiratory performance - Forced Expiratory Volume (FEV-1), Forced Vital Capacity (FVC)Timepoint: Baseline, Week 3 and Week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to the end of the study period in Cytokines / ChemokinesTimepoint: Baseline and Week 6;Change from baseline to the end of the study period in Heart rate and heart rate variabilityTimepoint: Baseline, Week 3 and Week 6;Change from baseline to the end of the study period in Immune status questionnaire (ISQ)Timepoint: Baseline, Week 3 and Week 6;Change from baseline to the end of the study period in Lymphocyte populationsTimepoint: Baseline and Week 6;Change from baseline to the end of the study period in Mood and Mental wellbeing questionnaire (PGWBI)Timepoint: Baseline, Week 3 and Week 6;Change from baseline to the end of the study period in Respiratory health questionnaire score (Wisconsin Upper Respiratory Symptom Survey-21)Timepoint: Baseline, Week 3 and Week 6;Change from baseline to the end of the study period in Six minute walk test (6MWT)Timepoint: Baseline, Week 3 and Week 6 | — |
Countries
India
Contacts
Public ContactAlluri Venkata Krishna Raju
Laila Nutraceuticals
Outcome results
None listed