Study of Koflet in Cough

An Open–Label, Two Arm Clinical Study to Evaluate the Efficacy and Safety of HKFH-081902 in Cough due to Varied Etiology - HKH

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/049070

Enrollment

200

Registered

2023-01-18

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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: Subjects presenting with primary acute common cold symptoms like cough and sore throat. Subjects presenting with associated secondary symptoms like chest congestion, sneezing, running nose. Subjects willing to sign informed consent and follow the study procedure. Subjects who have not participated in similar kind of investigation in past 4 weeks.

Exclusion criteria

Exclusion criteria: Subjects with clinically significant serious cardiovascular cerebrovascular, respiratory, hepatic, renal disease, congenital or any other disorder. Subjects with a VAS Score more than 7. Subjects suffering from accompanying illnesses such as bronchiolitis, pneumonia, pleuritis, septic infections, and other chronic respiratory disorder especially upper respiratory tract infection with complications. A known history or present condition of allergic response to pharmaceutical products its components or ingredients in the test product. Subjects on any medication that would affect the evaluation like anti histamines, steroids, OTC, or any other herbal medicines for the control of URTI symptoms. Pre-existing systemic disease necessitating long-term medications. Genetic and endocrinal disorders. Any history of seasonal or perennial allergic rhinitis. Pregnant and lactating women Subjects addicted to smoking, tobacco/ pan masala chewing or alcohol.

Design outcomes

Primary

Measure	Time frame
•Time required for onset of symptomatic relief from primary acute common cold symptoms like cough, sore throat •Time duration of effective and lasting symptomatic relief from primary acute common cold symptoms like cough, sore throatTimepoint: Outcome parameters are evaluated after every dose	—

Secondary

Measure	Time frame
NoneTimepoint: None	—

Countries

India

Contacts

Public ContactSushma C

Himalaya Wellness Company

dr.sooryanarayan.h@himalayawellness.com08067549919

Outcome results