Acute respiratory tract infections with symptoms such as cough, sore throat, fever and muscle ache where pneumonia is not suspected Respiratory
Conditions
Interventions
This is a multicentre, double-blind placebo-controlled feasibility study of Andrographis paniculata leaf extract. The study aims to recruit 60 participants.
Patients will eligible fo
Sponsors
University of Southampton
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years 2. Present to GP with a potential ARTI 3. Acute cough (=7 days' duration) or sore throat as main symptom 4. Symptoms localising to the upper respiratory tract (e.g. runny nose, sneezing, fever, muscle ache), for which non-infective diagnoses are judged very unlikely 5. Willing and able to give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant (or suspected to be pregnant) or breast feeding; patients who become pregnant during the trial will be asked to discontinue with the trial 2. Women at risk of pregnancy (i.e. not on effective contraception – combined oral contraceptive pill, an intrauterine hormonal device or subcutaneous hormonal trial implant) 3. Unable to complete trial documentation, including consent form and symptom diary including those who have difficulty understanding English 4. Already taking Andrographis or other herbal medicine for ARTIs 5. Known immunodeficiency state or undertaking chemotherapy treatment 6. Allergic/hypersensitive to Andrographis or capsule material (cellulose) 7. Already taking medication for ARTIs (paracetamol and ibuprofen will be allowed) 8. Severe hepatic and renal diseases (Chronic Kidney Disease Stage 4, GFR 130 bpm) 12. Recently/currently involved in a respiratory trial 13. Unable to provide informed consent or complete outcome measures 14. Are already involved in an ongoing trial or have recently been involved in a trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All of the feasibility timepoints will be evaluated after the study finishes (16 weeks): 1. Feasibility of eligibility criteria, assessed using number of patients included and number excluded (and reasons for exclusion) from the trial recorded in on-site screening logs 2. Feasibility of recruitment (ability to recruit patients into the intervention from those attending primary care) assessed using on-site enrolment record, with monthly rate/site adjusted for site list size. 3. Feasibility of randomisation (willingness to be randomised) assessed using the proportion of eligible patients recruited 4. Retention rate calculated from records of enrolment, withdrawal and completed diaries returned after 2 weeks 5. Intervention compliance assessed using patient-record diary data and returned intervention capsules 6. Suitability of the patient diaries and patients’ willingness to complete them and the importance of telephone/text contact from quantitative data collection - percentage of patients returning completed diaries | — |
Secondary
| Measure | Time frame |
|---|---|
| Rates of antibiotic prescription assessed using the participant's record in the diary of the day they started taking antibiotics, evaluated after the study finishes (16 weeks) | — |
Countries
United Kingdom
Outcome results
None listed