Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Randomized, controlled, open-label, multi-center trial to compare the efficacy and safety of three herbal medicinal products in the treatment of acute bronchitis

This important study is testing three different herbal medicines to see how well they treat acute bronchitis. Acute bronchitis is a common illness where the airways to your lungs become inflamed, often causing a cough and other chest symptoms. This study aims to find out if these herbal treatments can effectively reduce symptoms like coughing and make you feel better more quickly. Researchers will also be checking carefully to make sure these medicines are safe for people to use. If you have acute bronchitis, this type of research helps doctors understand the best ways to treat it, giving patients more options for relief and recovery. The study focuses on adults aged 18 and over.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Engelhard Arzneimittel GmbH & Co. KG

Enrolment target

300

Start

13 Feb 2024

Acute bronchitis

What is this study about?

This study is designed to compare three different herbal medicinal products that are already available and sometimes used to treat acute bronchitis. Acute bronchitis is a common condition where the tubes that carry air to your lungs get inflamed, often leading to a cough that can last for several weeks. The main goal of this research is to see if one of these herbal medicines works better than the others in easing your symptoms, especially your cough, over about seven days of treatment.

Researchers will be looking closely at how your symptoms change from when you start the treatment until seven days later. They will be using simple methods to ask you how you feel and to measure changes in your cough and other symptoms. This helps them understand if the medicines are making a real difference to people experiencing acute bronchitis. They will also be very focused on making sure the treatments are safe and don't cause any unexpected problems.

This type of study is called a 'Phase IV' study. This means the medicines being tested are already approved and available, but researchers want to gather more information about how well they work in a real-world setting and compare them directly. The results will help doctors in the UK and elsewhere make more informed decisions about treating acute bronchitis and offer patients effective and safe options.

Key takeaways

Tests three existing herbal medicines for acute bronchitis.
Aims to find out if they reduce symptoms like coughing effectively.
Focuses on safety and symptom improvement over 7 days.
Open to adults aged 18 and over, both men and women.
Helps doctors understand the best treatments for acute bronchitis.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

The most important thing is that you have acute bronchitis. This is a common chest infection that usually causes a cough. The study will confirm if your specific symptoms match what they are looking for.

Beyond having acute bronchitis and being over 18, there might be other specific health requirements or conditions that would prevent you from taking part. The study team will discuss these with you in detail to ensure it's safe and appropriate for you to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you currently have acute bronchitis?
Are you able to attend study visits or have contact with the study team?
Are you willing to take one of the study herbal medicines for about a week?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be asked to attend several visits during a period of about seven days of treatment. At your first visit, the study team would check your symptoms and discuss the study in detail. You would then be given one of the three herbal medicines to take for about a week.

Throughout the study, you would have follow-up visits or contact with the study team to answer questions about how you're feeling and how your symptoms are changing. You might be asked to complete questionnaires or small tests to measure your cough or other symptoms. All these assessments help the researchers understand how well the medicine is working for you. There will also be a few follow-up checks after the week of treatment to see how you are recovering in the longer term.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from receiving a treatment that could help improve your acute bronchitis symptoms. Your participation also helps advance medical knowledge, potentially leading to better treatments for others in the future. As for risks, since these are widely used herbal medicines, serious side effects are generally uncommon, but like any medicine, they can occur. The study team will carefully monitor you for any side effects and explain all known risks to you before you agree to participate. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is acute bronchitis?

Acute bronchitis is a common chest infection where the breathing tubes in your lungs become irritated and inflamed, often causing a cough.

Are the medicines in this study new?

No, the medicines being studied are herbal products that are already available and used for coughs and bronchitis. This study is comparing them.

How long will I be involved in the study?

You'll be taking the medicine for about 7 days, with several visits or contacts during that time and a few follow-up checks afterwards.

Do I have to take part if I'm asked?

No, participation is completely voluntary. It's your choice, and you can withdraw at any time without it affecting your ongoing medical care.

Will I know which medicine I'm getting?

Yes, 'open-label' means you and the study team will know which of the three herbal medicines you are taking.