A research by your doctor to check the use of medicine Enkor-KT against cold and sore throat.
- Conditions
- Health Condition 1: A488- Other specified bacterial diseasesHealth Condition 2: B974- Respiratory syncytial virus as thecause of diseases classified elsewhere
- Registration Number
- CTRI/2020/05/025098
- Lead Sponsor
- Tenshi LifeCare Pvt Ltd Bengaluru Karnataka
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Male and Female volunteers of 18 to 60 years of age suffering from common cold and pharyngitis
2.Subjects must participate fully and be willing to comply with the procedures of the protocol.
3.Ability of subject to understand and provide voluntary, written, informed consent to participate in the study.
4.Subjects agree to not substantially change diet, medications or exercise routine.
1.Patients using probiotic supplements during the past 4 weeks, prior to screening.
2.Patients on antibiotic therapy or who were on antibiotic therapy in the past1 month.
3.Patients who are deemed to be uncooperative.
4.Administration of systemic immunosuppressants in the previous 3 months, prior to screening.
5.Subjects with a primary or acquired immunodeficiency, including HIV seropositivity.
6.Subjects receiving or planning to receive an investigational new drug (IND) agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants.
7.Hypersensitivity to any components contained in the probiotic capsules/sachets.
8.Individuals who are cognitively impaired and/or who are unable to give informed consent.
9.Any other condition which in the Investigatorâ??s opinion may adversely affect the subjectâ??s ability to complete the study or its measures or which may pose a significant risk to the subject.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete relief from pharyngitis and common coldTimepoint: At baseline, 7 plus minus 4 days and 14 plus minus 4 days
- Secondary Outcome Measures
Name Time Method Clinical examination reveals normal oropharynx with no signs of congestionTimepoint: Clinical examination done after 14 days