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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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24 November 2021 |
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Main ID: |
CTRI/2016/12/007518 |
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Date of registration:
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01-12-2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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To study the role of Probiotic HU58 on Immune Function in Healthy Human.
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Scientific title:
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An Open Labeled Trial to Evaluate Role of Probiotic- HU58 on Immune Function in Healthy Human
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Date of first enrolment:
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13-06-2016 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=16856 |
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Study type:
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Interventional |
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Study design:
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Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
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Phase:
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Phase 4
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Countries of recruitment
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India
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Contacts
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Name:
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Dr Yogesh Dound
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Address:
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6/312, Jogani Industrial Complex, V. N. Purav Marg, Chunabhatti, Mumbai â?? 400 022
400022
Mumbai, MAHARASHTRA
India |
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Telephone:
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02224055607 |
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Email:
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yogesh_dound@yahoo.com |
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Affiliation:
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Synergia Life Sciences Pvt. Ltd. |
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Name:
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Dr Yogesh Dound
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Address:
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6/312, Jogani Industrial Complex, V. N. Purav Marg, Chunabhatti, Mumbai â?? 400 022
400022
Mumbai, MAHARASHTRA
India |
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Telephone:
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02224055607 |
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Email:
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yogesh_dound@yahoo.com |
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Affiliation:
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Synergia Life Sciences Pvt. Ltd. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1.Male and female aged 18 to 65.
2.Stable ECG.
3.Willing to give informed consent.
Exclusion criteria: 1.Known medical history of any systemic illness.
2.ESR above 20 and suffering from any infection (local and systemic).
3.Sero positive patients.
4.Pregnancy.
5.Subjects who are on other Probiotics or prebiotics.
6.Subjects who are addicted to tobacco, alcohol.
7.Subjects who are on any current medication.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Intervention(s)
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Intervention1: Probiotic Bacillus subtilis HU58 Capsules: Each capsule to be given once a day orally after food for 8 weeks.
Control Intervention1: Nil: Nil
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Primary Outcome(s)
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The primary objective of the study is to evaluate the role of Probiotic- HU58 on immune function in healthy humans.Timepoint: 8 weeks
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Secondary Outcome(s)
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Safety and tolerability; clinical variablesTimepoint: 8 weeks
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Secondary ID(s)
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VBP â?? Probiotics-02 /16, Version 1 dt 10/01/16
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Source(s) of Monetary Support
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Synergia Life Sciences Pvt Ltd, 6/312, Jogani Industrial Complex, V. N. Purav Marg, Chunabhatti,
Mumbai â?? 400 022, India.
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Ethics review
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Status: Approved
Approval date: 27/02/2016
Contact:
Inter System BioMedica Ethics Committee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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