A study to check if an Ayurvedic mouth-dissolving tablet helps relieve cough, sore throat, hoarseness of voice and bad breath

An open-label, single-arm clinical study to assess the efficacy and safety of a Mouth-Dissolving Ayurvedic Tablet (MDAT) for symptomatic relief of acute cough, sore throat, hoarseness of voice and bad breath. - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/03/105779

Enrollment

Registered

2026-03-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: J069- Acute upper respiratory infection,unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male and Female age between 12 and 65 years. 2. Acute or subacute cough with sore throat or hoarseness or bad breath of less than or equal to 14 days duration (onset less than or equal to 14 days). 3. Baseline cough VAS greater than or equal to 3 out of 10. 4. Able and willing to comply with study procedures and give written informed consent. 5. Women of childbearing potential using reliable contraception, during the study period.

Exclusion criteria

Exclusion criteria: 1. Known allergy to any ingredient in the tablet. 2. Severe upper (pharyngitis) or lower respiratory infection (e.g., pneumonia), clinically suspected bacterial throat infection requiring antibiotics, or any condition requiring immediate hospitalization. 3. Chronic severe respiratory disease (e.g., COPD GOLD stage II IV, uncontrolled asthma). 4. Use of oral or inhaled antibiotics or systemic corticosteroids in past 7 days. 5. Use of other cough or antitussive or antiseptic throat lozenges within 12 hours before baseline (short washout may be requested). 6. Pregnant or breastfeeding women. 7. Significant hepatic, renal, cardiac disease or immunosuppression. 8. Current smoker of grater then 20 cigarettes per day (optional exclusion), or any other condition in investigator s opinion that precludes participation.

Design outcomes

Primary

Measure	Time frame
Mean change in cough VASTimepoint: baseline to day 7	—

Secondary

Measure	Time frame
Mean change in sore throat, throat comfort and ease of swallowing by VAS Mean change in VHI-10 Mean change in organoleptic score and Halimeter scores for bad breath Mean time to meaningful cough relief. Proportion of participants with greater than or equal 50% reduction in cough VAS by Day 3 and Day 7. For safety assessment screening lab parameters will be repeated Number and severity of AEs. Timepoint: baseline to day 7	—

Measure

Time frame

Mean change in sore throat, throat comfort and ease of swallowing by VAS Mean change in VHI-10 Mean change in organoleptic score and Halimeter scores for bad breath Mean time to meaningful cough relief. Proportion of participants with greater than or equal 50% reduction in cough VAS by Day 3 and Day 7. For safety assessment screening lab parameters will be repeated Number and severity of AEs. Timepoint: baseline to day 7

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Countries

India

Contacts

Public ContactDr Gayathri Sivakumar

KI3 PRIVATE LIMITED

saheerose@gmail.com9443627722

Outcome results