A clinical study to assess efficacy of Alviolife and Alviolife Plus on improving respiratory function in healthy subjects sensitive to air pollutio

Not Applicable

Completed

• Registration Number: CTRI/2020/10/028721
• Lead Sponsor: aila Nutraceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

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.

� 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.

� Subjects willing to walk for 6 minutes as per the study procedure.

� Subject agrees to maintain a diet tracker.

� Subject considered generally healthy as per health history and routine clinical investigations during screening.

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-Provera�®, or double-barrier and have a negative pregnancy test at the screening visit.

� Ability to understand the risks/benefits of the protocol and willing to sign the written informed consent.

Exclusion Criteria

� Subjects suffering from or with a history of chronic respiratory disorders such as Asthma, chronic obstructive pulmonary disorders (COPD), bronchitis, etc.

� Use of any vitamin supplements or multivitamin

� Subjects with the habit of chewing tobacco, or smoking

� Subjects with a history of thyroid dysfunction

� Subjects underwent treatment for COVID 19

� Subjects with current treatment for CVD, heart attack or stroke.

� Immune modifying medications ( Anti-inflammatory agents, Antibiotics, anti-histaminics, etc.- for last one month, Steroids- for last 03 months)

� 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.

� Subjects who used immunosuppressive drugs in the last 5 years.

�Subjects with Diabetes or Hypertension.

� Liver function tests > 2 X upper limit of normal (ULN) and/or Creatinine > 1.5 ULN

� Alcohol intake >2 standard drinks per day or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)

� Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic neurologic diseases, malignancies

� Female subjects who are pregnant, breast feeding or planning to become pregnant during the study.

� 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.

� Use of other nutritional supplements within 30 days prior to the study.

� Subjects who participated or currently participating in another clinical trial within 30 days prior to screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified