A research by your doctor to check the use of medicine Enkor-KT against cold and sore throat.

A Prospective, Open-label, Investigator Initiated Study to Evaluate the Efficacy and Safety of Probiotic (Enkor-KT) for the treatment of common cold and pharyngitis: Randomized, Controlled Study

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/05/025098

Enrollment

240

Registered

2020-05-11

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: A488- Other specified bacterial diseases Health Condition 2: B974- Respiratory syncytial virus as thecause of diseases classified elsewhere

Interventions

Intervention1: Enkor-KT containing 1.25 billion CFU of Streptococcus Salivarius.: The product is in the form of sachets. It has sugar free, calorie free xylitol base. 2 sachets two times a day for 7 d

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Complete relief from pharyngitis and common coldTimepoint: At baseline, 7 plus minus 4 days and 14 plus minus 4 days	—

Secondary

Measure	Time frame
Clinical examination reveals normal oropharynx with no signs of congestionTimepoint: Clinical examination done after 14 days	—

Countries

India

Contacts

Public ContactDr Atul Deshmukh

Padmashree Dr. D Y Patil University Navi Mumbai

atul.deshmukh@dypatil.edu9821769405

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026