CLINICAL STUDY TO EVALUATE IMMUNITY MODULATING EFFECTS ON HEALTHY SUBJECTS
- Registration Number
- CTRI/2020/09/027961
- Lead Sponsor
- Tenshi Kaizen Pvt Ltd India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
1. Male or female subject who have provided voluntary informed consent for participation in study and to follow the protocol requirements.
2. Normal healthy human adult subjects between 19-60 years (both inclusive) of age who is able to read and write (any language).
3. Body mass index of 18.50 to 29.90 kg/m2 (both inclusive).
4. No evidence of any other underlying disease during the screening, medical history, clinical examination and laboratory investigations performed within 28 days of dosing initiation.
5. Screening laboratory tests (hematology, biochemistry, liver function and other enzyme tests, serology, urinalysis) are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to participation in the study.
6. Normal chest X-ray taken within 6 months before the day of dosing initiation.
7. 12-lead ECG recording within normal or within acceptable limits or are of no clinical significance with respect to his participation in the study as confirmed by the investigator.
8. Subjects who are ready to available for the entire study period and are capable of understanding and communicating with the investigator and clinical study facility staff.
9. No history of addiction to any recreational drug or drug dependence or alcohol addiction.
10. Female subject must have used an acceptable method of contraception during intercourse at least 48.00 hours prior to dosing of IP, and must agree to use during the study & for 07 days after study completion.
11. Subjects should be able to chew the IP on daily basis.
1. Known hypersensitivity or contraindication to probiotics or to any of the components of investigational product or to any of the related products.
2. History or presence of any other significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease.
3. History of abnormal bleeding tendencies / clotting disorders.
4. History of chronic smoking (more than 10 units per day of cigarettes, bidis, or any other form) or chronic consumption of tobacco products.
5. History/presence of significant asthma, urticaria or other allergic type reactions after taking any medication.
6. History/presence of any other clinically significant illness within 04 weeks before the start of the study.
7. Subjects scheduled for surgery any time during study or at least within 20 days after study completion.
8. History of difficulty in donating blood.
9. Subjects who have unsuitable veins for repeated vein puncture.
10. Donation and/or loss of greater or equal to 350 mL (1 unit) of blood within 90 days prior to first dose of Investigational product for the current study.
11. Evidence of skin lesions on forearm or signs of vein puncture on the forearm suggestive of recent donation or participation in clinical trial.
12. Subjects who have participated in a clinical drug study or bioequivalence study within 90 days prior to the first dose of study medication or subjects who have not completed sufficient days of no participation in clinical study as indicated by the investigator/ institute of the last study participation as reflected in OVIS.
13. Subjects who have taken any other prescription medication or OTC products (including vitamins and natural products) within 14 days prior to dosing of IP, including topical medication.
14. Subjects with significant medical conditions or laboratory results that, in the opinion of the investigator, would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements
15. Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV), RPR/VDRL.
16. Subjects with positive urine screen for drugs of abuse.
17. Subjects with positive alcohol breath test.
18. Female subject with positive serum pregnancy test or urine pregnancy test.
19.Subject who have consumed tobacco containing products (smoking, tobacco chewing, gutkha etc.) and xanthine containing food and beverages, (chocolates, tea, coffee or cola drinks) for at least 48.00 hours (02 days) prior to start of administration of IP or subject who is not ready to abstain them till last study related procedure.
20. Subject who have consumed alcohol, grapefruit or its juice and cranberry juice for at least 48.00 hours (02 days) prior to start of administration of IP or Subject who is not ready to abstain them till last study related procedure.
21. Subject who have taken any medication (including over-the-counter products), and recreational drugs such as Cocaine, Marijuana, Amphetamine, Morphine, Benzodiazepine, and Barbiturates, 14 days prior to start of administration of IP or subject who is not ready to abstain them till last study related procedure. This includes vitamins taken as nutritional suppl
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the immunomodulatory effectTimepoint: day 31 and day 61
- Secondary Outcome Measures
Name Time Method To assess the immunomodulatory effectTimepoint: Day 31 and day 61