Study on the Effectiveness and Safety of Myrrh, Coffee Charcoal, and Chamomile Extract for Patients with Diarrhea-Dominant or Mixed-Type 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 two types of irritable bowel syndrome: diarrhea-dominant irritable bowel syndrome (IBS-D) and mixed-type irritable bowel syndrome (IBS-M). MYRRHINIL-INTEST® is a coated tablet that contains natural ingredients such as myrrh, coffee charcoal, and a dry extract from chamomile flower. The purpose of the study is to evaluate how effective and safe this treatment is compared to a placebo, which looks like the treatment but does not contain the active ingredients.

Participants in the study will take either the MYRRHINIL-INTEST® tablets 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 abdominal pain, stool consistency, and frequency of bowel movements. The study will involve several visits to the study center, where participants will have their symptoms assessed and their overall gut health evaluated. The study aims to see if the treatment can help reduce symptoms like abdominal pain and improve the quality of life for those with IBS-D and IBS-M.

Throughout the study, participants’ health will be monitored closely, including checking vital signs like blood pressure and pulse, and conducting blood tests. The study will also track any side effects that may occur. The goal is to determine if MYRRHINIL-INTEST® is a safe and effective option for managing symptoms of irritable bowel syndrome.

1 initial visit and assessment

The initial visit involves a comprehensive assessment to confirm eligibility for the study. This includes a review of medical history and symptoms related to irritable bowel syndrome (IBS).

A stool sample is collected to rule out other conditions. The patient is required to provide a signed informed consent form.

2 baseline measurements

Baseline measurements are taken, including the severity of IBS symptoms using the IBS-Severity Scoring System (IBS-SSS) and the quality of life using the IBS-QoL questionnaire.

Vital signs such as blood pressure, pulse, and body temperature are recorded.

3 medication administration

The patient receives either MYRRHINIL-INTEST® or a placebo. The medication is in the form of a coated tablet containing 100 mg of myrrh, 50 mg of coffee charcoal, and 70 mg of chamomile extract.

The dosage and frequency of administration are determined by the study protocol.

4 daily diary entries

The patient is required to maintain a daily diary to record symptoms such as abdominal pain, stool consistency, and frequency of bowel movements.

The diary also includes entries on the occurrence of mucus or blood in the stool and the feeling of incomplete bowel evacuation.

5 follow-up visits

Follow-up visits are scheduled to monitor progress and assess the efficacy and safety of the treatment. These visits occur at specified intervals throughout the study.

During these visits, the patient completes assessments of symptom severity and quality of life, and vital signs are checked.

6 final assessment

At the end of the study, a final assessment is conducted to evaluate the overall changes in gut health using the Patient Global Impression of Improvement Scale (PGI-I).

The investigator and the patient provide a global assessment of the treatment’s efficacy.

Who Can Join the Study?

The patient must not have experienced weight loss in the past 6 months.
No symptoms during the night, such as abdominal pain or diarrhea.
No family history of colon cancer in first-degree relatives.
Assessment of symptoms related to Irritable Bowel Syndrome (IBS) with diarrhea (IBS-D) or mixed type (IBS-M) using specific scales and criteria.
The patient must have a signed informed consent form.
The patient agrees not to change their lifestyle or diet during the study.
No chronic inflammatory bowel diseases, such as ulcerative colitis or Crohn’s disease, confirmed by a colon examination in the last 5 years for those over 55 years old.
The patient must be willing to keep a detailed diary during the study.
A negative pregnancy test is required for individuals who can become pregnant.
Stool samples must be provided, with no significant blood or signs of infection, except for minor issues like hemorrhoids.
Patients must be between 18 and 75 years old.
A confirmed diagnosis of IBS-D or IBS-M according to specific criteria, including recurrent abdominal pain associated with bowel movements or changes in stool.

Who Cannot Join the Study?

Patients who have other serious health conditions that might interfere with the study.
Patients who are currently participating in another clinical trial.
Patients who have had recent surgery or plan to have surgery during the study period.
Patients who are pregnant or breastfeeding.
Patients who have a history of alcohol or drug abuse.
Patients who are unable to follow the study procedures or instructions.
Patients who have allergies to the study medication or its ingredients.
Patients who have been diagnosed with certain other digestive disorders.
Patients who are taking medications that might interfere with the study treatment.
Patients who have a history of severe mental health issues.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Klinische Forschung Karlsruhe GmbH	Karlsruhe	Germany

Other Sites

Site Name	City	Country
Klinische Forschung Berlin-Mitte GmbH	Berlin	Germany
Klinische Forschung Hamburg GmbH	Hamburg	Germany
medicoKIT GmbH	Goch	Germany
Charite Research Organisation GmbH	Berlin	Germany
Praxisgemeinschaft Jerichow Schulze	Jerichow	Germany
Klinische Forschung Schwerin GmbH	Schwerin	Germany
Centrum Gastroenterologie Bethanien	Frankfurt	Germany
Kfrhgstmk Ffmbmazkq Dxfsgrd Gmeu	Dresden	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	06.05.2020

Trial locations

Investigated drugs:

MYRRHINIL-INTEST® is a medication being studied for its effectiveness and safety in treating irritable bowel syndrome, specifically the types that cause diarrhea (IBS-D) and a mix of symptoms (IBS-M). This medication aims to help manage the symptoms associated with these conditions, such as abdominal pain and irregular bowel movements, by potentially providing relief and improving the quality of life for patients.

Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) – This condition is a type of irritable bowel syndrome characterized by frequent diarrhea. It involves recurring abdominal pain or discomfort, often accompanied by changes in bowel habits. The pain is typically relieved after a bowel movement. Patients may experience an urgent need to have a bowel movement and may notice changes in stool consistency. Symptoms can vary in intensity and may be triggered by certain foods or stress. The condition is chronic, with periods of symptom flare-ups and remissions.

Mixed-type Irritable Bowel Syndrome (IBS-M) – This form of irritable bowel syndrome involves alternating episodes of diarrhea and constipation. Individuals with IBS-M experience abdominal pain or discomfort that is associated with changes in bowel habits. The pain may be relieved by defecation, and the stool consistency can vary significantly. Symptoms can be unpredictable and may be influenced by diet, stress, or other factors. The condition is ongoing, with symptoms that can fluctuate over time.

Trial ID:

2024-514892-16-00

Protocol code:

Repha_1436

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-Dominant or Mixed-Type Irritable Bowel Syndrome

What is this study about?

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