Study on the Effectiveness and Safety of Myrrh, Coffee Charcoal, and Chamomile Extract for Patients with Diarrhea-Predominant Irritable Bowel Syndrome

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What is this study about?

This clinical trial is focused on studying the effects of a treatment called MYRRHINIL-INTEST® on patients with diarrhea-predominant irritable bowel syndrome (IBS-D). This condition is a type of irritable bowel syndrome where diarrhea is the main symptom. The treatment being tested is a coated tablet that contains natural ingredients such as myrrh, coffee charcoal, and a dry extract from chamomile flower. These ingredients are known for their potential to help with digestive issues.

The purpose of the study is to evaluate how effective and safe MYRRHINIL-INTEST® is compared to a placebo, which looks like the treatment but does not contain any active ingredients. Participants in the study will take either the treatment or the placebo for a period of up to eight weeks. During this time, they will be asked to keep a diary to record their symptoms, such as stool frequency and consistency, and any feelings of incomplete bowel movements. The study will also assess the overall quality of life and any changes in the severity of IBS-D symptoms.

Throughout the study, participants will have regular visits to the study center to monitor their progress and ensure their safety. These visits will include assessments of vital signs like blood pressure and pulse, as well as checks on clinical chemistry and hematology, which are tests that look at blood and other bodily fluids. The study aims to provide valuable information on whether MYRRHINIL-INTEST® can be a helpful treatment option for those suffering from IBS-D.

1 Initial Visit and Screening

Upon joining the study, an initial visit is conducted to confirm eligibility. This includes a diagnosis of diarrhoea-dominant irritable bowel syndrome (IBS-D) and a negative pregnancy test for those of childbearing potential.

A colon examination is required for participants over 55 years of age, performed within the last five years.

Stool samples are collected to test for the absence of blood and Clostridioides difficile infection.

Participants are required to document stool consistency using the Bristol Stool Form Scale and assess IBS-D symptoms.

2 Consent and Lifestyle Agreement

Participants must provide a signed declaration of consent.

Agreement to avoid changes in lifestyle and dietary habits during the study is required.

Participants must commit to maintaining a patient diary as per the study protocol.

3 Treatment Phase

Participants receive either MYRRHINIL-INTEST® or a placebo. The active medication contains 100 mg of myrrh, 50 mg of coffee charcoal, and 70 mg of chamomile flower extract.

The medication is administered in the form of a coated tablet for oral use.

Participants are required to document daily stool frequency, consistency, and any occurrences of incomplete defecation in their diary.

4 Regular Assessments

Throughout the study, participants attend visits to assess the severity of IBS-D symptoms using the IBS-Severity Scoring System.

Quality of life is evaluated using the IBS-QoL questionnaire.

Vital parameters such as blood pressure, pulse, and body temperature are monitored.

5 End of Study Evaluation

At the end of the study, a global assessment of efficacy is conducted by both the investigator and the participant.

Compliance with the study medication is evaluated based on the patient diary and drug accountability.

Adverse events and any changes in clinical chemistry and hematology are reviewed.

Who Can Join the Study?

Patients of both sexes aged between 18 and 75 years.
A negative pregnancy test is required for individuals who can become pregnant.
A confirmed diagnosis of diarrhoea-dominant irritable bowel syndrome (IBS-D) at the first visit.
For patients older than 55 years, a colon examination, known as a colonoscopy, must have been performed within the last 5 years before joining the study.
Before the first visit, patients must have had at least one watery bowel movement per day on at least 3 days in the last week.
Assessment of IBS-D symptoms includes:
- Pain score greater than 3 points at the first and second visits.
- Stool consistency recorded by the patient using the Bristol stool form scale at the first and second visits.
Stool samples must show no blood and no infection with Clostridioides difficile, a type of bacteria, using a specific test called glutamate dehydrogenase (GDH) ELISA at the second visit.
The patient must sign a consent form agreeing to participate in the study.
The patient must agree not to change their lifestyle and eating habits during the study.
The patient must be willing to keep a diary according to the study’s instructions.

Who Cannot Join the Study?

Individuals who do not have diarrhea-predominant irritable bowel syndrome (IBS-D) cannot participate. IBS-D is a condition where a person often experiences diarrhea along with stomach pain or discomfort.
Participants must be within the specified age range for the study. If you are outside this age range, you cannot participate.
Both males and females can participate, but if you do not identify as either, you may not be eligible.
If you belong to a group considered vulnerable, such as those unable to give informed consent, you cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Eugastro GmbH	Leipzig	Germany
Siteworks GmbH	Hanover	Germany
KRH Klinikum Siloah	Hanover	Germany
Klinische Forschung Berlin GbR	Berlin	Germany
Sozialstiftung Bamberg Medizinisches Versorgungszentrum am Bruderwald gGmbH	Bamberg	Germany
Centrum Gastroenterologie Bethanien	Frankfurt	Germany
Praxis Dr. Joachim Weimer	Reinfeld	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	07.07.2020

Trial locations

Investigated drugs:

MYRRHINIL-INTEST is a medication being studied for its effectiveness and safety in treating patients with irritable bowel syndrome that is mainly characterized by diarrhea (IBS-D). The trial aims to determine how well this medication works in reducing symptoms and how safe it is for patients to use.

Diarrhea-predominant irritable bowel syndrome – This condition is a type of irritable bowel syndrome (IBS) where diarrhea is the main symptom. It involves frequent, loose, or watery stools, often accompanied by abdominal pain or discomfort. The pain is typically relieved after a bowel movement. People with this condition may also experience bloating and an urgent need to have a bowel movement. The symptoms can vary in intensity and may fluctuate over time. It is a chronic condition that can significantly impact daily life and quality of life.

Trial ID:

2024-514383-61-00

Protocol code:

Repha_1439

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effectiveness and Safety of Myrrh, Coffee Charcoal, and Chamomile Extract for Patients with Diarrhea-Predominant Irritable Bowel Syndrome

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?