Clinical study of KVM syrup in persistent acute cough of children

Evaluation of the efficacy and safety of KVM Syrup (Coded Ayurvedic Formulation) in the management of persistent acute cough in children - A multicenter double blind placebo controlled clinical trial - NIL

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/04/085923

Enrollment

160

Registered

2025-04-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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

Conditions

Health Condition 1: R05- Cough

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Children with a persistent acute cough lasting from 7 days to 2 weeks, with CSS score greater than or equal to 3, and history of symptoms of acute upper respiratory tract infection 2.Children between 6-12 years of age

Exclusion criteria

Exclusion criteria: 1.Cases presenting with fever, chronic (cough since more than 2 weeks) and/or progressive cough, haemoptysis, cyanosis or clubbing 2.Cases with ongoing medications like anti-histamines, bronchodilators, cough suppressant, antibiotics etc. 3.Known cases of foreign body aspiration, Pneumonia, bronchial asthma, Cystic fibrosis, Tuberculosis, Malignancy, Emphysema, COPD, Bronchiectasis, Pertussis or other severe LRTI, Heart disease or Juvenile Diabetes Mellitus, Immunodeficiency 4.Children having contact history of tuberculosis or weight loss more than 5% within last 3 months, or exposure to passive smoking 5.Children suffering from any other major systemic illness necessitating long term drug treatment.

Design outcomes

Primary

Measure	Time frame
Change in the score of Cough Symptom Score (CSS)Timepoint: Baseline, 7th day and 14th day	—

Secondary

Measure	Time frame
Proportion of participants with complete relief in cough (CSS score 0) after treatmentTimepoint: Baseline, 7th day and 14th day;Need for rescue medication during the study periodTimepoint: Baseline, 7th day and 14th day;Incidence of treatment-emergent adverse events or any Adverse drug reactions during the study periodTimepoint: Baseline, 7th day and 14th day;Proportion of participants adhering to Ayurvedic medication (greater than or equal to 80%) during the study periodTimepoint: 7th day and 14th day	—

Measure

Time frame

Proportion of participants with complete relief in cough (CSS score 0) after treatmentTimepoint: Baseline, 7th day and 14th day;Need for rescue medication during the study periodTimepoint: Baseline, 7th day and 14th day;Incidence of treatment-emergent adverse events or any Adverse drug reactions during the study periodTimepoint: Baseline, 7th day and 14th day;Proportion of participants adhering to Ayurvedic medication (greater than or equal to 80%) during the study periodTimepoint: 7th day and 14th day

—

Countries

India

Contacts

Public ContactDr Kuldeep Choudhary

CCRAS - RRAP CARI Mumbai

kuldeepall@yahoo.co.in8198865710

Outcome results