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Dry Extract From Chamomile Flower (4-6:1): Extraction Solvent: Ethanol 60% (M/M)

This article discusses clinical trials investigating the use of a drug containing dry extract from chamomile flower, along with myrrh and coffee charcoal, for treating irritable bowel syndrome (IBS). The trials focus on patients with diarrhea-predominant IBS (IBS-D) and mixed-type IBS (IBS-M), evaluating the drug’s efficacy, safety, and tolerability compared to a placebo.

Table of Contents

What is Chamomile Extract?

Chamomile extract is a natural substance derived from chamomile flowers. In the context of this article, we’re focusing on a specific formulation called “DRY EXTRACT FROM CHAMOMILE FLOWER (4-6:1): EXTRACTION SOLVENT: ETHANOL 60% (M/M)”. This extract is one of the active ingredients in a medication called MYRRHINIL-INTEST®, which also contains myrrh and coffee charcoal[1].

Medical Uses

MYRRHINIL-INTEST®, which contains chamomile extract, is primarily used to treat Irritable Bowel Syndrome (IBS), particularly the diarrhea-predominant (IBS-D) and mixed (IBS-M) subtypes[1]. IBS is a common digestive disorder characterized by abdominal pain, bloating, and changes in bowel habits.

Specifically, this medication is being studied for its effectiveness in:

  • Reducing abdominal pain associated with IBS
  • Improving stool consistency in patients with diarrhea-predominant IBS
  • Enhancing overall bowel health in patients with mixed-type IBS

How It Works

While the exact mechanism of action is not fully understood, chamomile extract is believed to have several beneficial properties:

  • Anti-inflammatory effects: Chamomile may help reduce inflammation in the digestive tract.
  • Antispasmodic properties: It may help relax the smooth muscles of the intestines, potentially reducing cramping and pain.
  • Calming effects: Chamomile is known for its mild sedative properties, which might help reduce stress-related digestive symptoms.

The combination with myrrh and coffee charcoal in MYRRHINIL-INTEST® is thought to provide a synergistic effect in managing IBS symptoms[2].

Clinical Trials

Two clinical trials are currently investigating the efficacy and safety of MYRRHINIL-INTEST® for IBS:

  1. A study focusing on patients with diarrhea-predominant IBS (IBS-D)[1].
  2. A study including both diarrhea-predominant (IBS-D) and mixed-type IBS (IBS-M) patients[2].

These trials aim to assess:

  • The medication’s effectiveness in reducing abdominal pain
  • Improvements in stool consistency and frequency
  • Overall changes in IBS symptoms and quality of life
  • The safety and tolerability of the medication

Dosage and Administration

MYRRHINIL-INTEST® is typically administered as coated tablets. In the clinical trials, the maximum daily dose is 12 tablets, with a total treatment period of up to 8 weeks[2]. However, the exact dosage may vary depending on individual patient needs and should be determined by a healthcare professional.

Potential Side Effects

While the full safety profile is still being investigated in the clinical trials, potential side effects may include:

  • Allergic reactions, especially in people with known sensitivities to chamomile or related plants
  • Gastrointestinal discomfort
  • Interactions with other medications

It’s important to note that the clinical trials are designed to carefully monitor and assess any adverse events that may occur during treatment[1].

Precautions and Contraindications

Based on the clinical trial exclusion criteria, MYRRHINIL-INTEST® may not be suitable for:

  • Patients with inflammatory bowel diseases like ulcerative colitis or Crohn’s disease
  • Individuals with known hypersensitivity to chamomile, myrrh, or coffee charcoal
  • Patients with certain liver or kidney dysfunctions
  • Pregnant or breastfeeding women
  • Patients with certain other medical conditions or taking specific medications

Always consult with a healthcare professional before starting any new medication, including herbal supplements like chamomile extract[2].

Aspect Details
Drug Name MYRRHINIL-INTEST®
Active Ingredients Myrrh, Coffee Charcoal, Dry Extract from Chamomile Flower
Conditions Studied Diarrhea-predominant IBS (IBS-D), Mixed-type IBS (IBS-M)
Primary Endpoints Reduction in abdominal pain, improvement in stool consistency (IBS-D), overall bowel health improvement (IBS-M)
Key Inclusion Criteria Age 18-75, confirmed IBS-D or IBS-M diagnosis, specific symptom requirements
Key Exclusion Criteria Other gastrointestinal diseases, recent antibiotic use, pregnancy/breastfeeding
Assessment Tools NRS Pain, Bristol Stool Form Scale, IBS-SSS, IBS-QoL, PGI-I
Treatment Duration Up to 8 weeks

FAQ

  • What is the main purpose of these clinical trials? The main purpose is to evaluate the effectiveness, safety, and tolerability of MYRRHINIL-INTEST® compared to a placebo in treating diarrhea-predominant irritable bowel syndrome (IBS-D) and mixed-type irritable bowel syndrome (IBS-M).
  • What are the key ingredients in the drug being tested? The drug being tested, MYRRHINIL-INTEST®, contains three main ingredients: myrrh, coffee charcoal, and dry extract from chamomile flower (4-6:1) with ethanol 60% (m/m) as the extraction solvent.
  • Who can participate in these clinical trials? Participants must be between 18 and 75 years old, diagnosed with IBS-D or IBS-M according to Rome IV criteria, and meet specific symptom requirements. They should not have certain medical conditions like inflammatory bowel diseases or diabetes.
  • How is the effectiveness of the drug measured in these trials? The effectiveness is primarily measured by assessing changes in abdominal pain and stool consistency. For IBS-D patients, improvements in both pain and stool consistency are required. For IBS-M patients, improvements in pain and overall bowel health are assessed.
  • What are some of the exclusion criteria for these trials? Exclusion criteria include having other gastrointestinal diseases like ulcerative colitis or Crohn's disease, recent use of antibiotics or certain medications, pregnancy or breastfeeding, and severe psychiatric disorders that might affect participation.

Ongoing Clinical Trials on Dry Extract From Chamomile Flower (4-6:1): Extraction Solvent: Ethanol 60% (M/M)

  • Study on the Effectiveness and Safety of Myrrh, Coffee Charcoal, and Chamomile Extract for Patients with Diarrhea-Dominant or Mixed-Type Irritable Bowel Syndrome

    Recruiting

    3 1 1
    Investigated drugs:
    Germany

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

    Recruiting

    3 1 1
    Investigated drugs:
    Germany

Glossary

  • Irritable Bowel Syndrome (IBS): A common disorder affecting the large intestine, characterized by abdominal pain and changes in bowel habits.
  • IBS-D: Diarrhea-predominant Irritable Bowel Syndrome, where loose stools are more common than constipation.
  • IBS-M: Mixed-type Irritable Bowel Syndrome, where both diarrhea and constipation occur regularly.
  • Rome IV criteria: A set of diagnostic criteria used to identify and classify functional gastrointestinal disorders, including IBS.
  • Placebo: An inactive substance or treatment used in clinical trials to compare the effects of a drug.
  • Bristol Stool Form Scale: A medical aid used to classify the form of human feces into seven categories.
  • NRS Pain: Numerical Rating Scale for Pain, used to measure pain intensity on a scale from 0 to 10.
  • IBS-SSS: IBS Severity Scoring System, a tool used to assess the severity of IBS symptoms.
  • IBS-QoL: IBS Quality of Life questionnaire, used to measure the impact of IBS on a patient's quality of life.
  • PGI-I: Patient Global Impression of Improvement scale, used to assess overall changes in a patient's condition.

References

  1. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-myrrh-coffee-charcoal-and-chamomile-extract-for-patients-with-diarrhea-predominant-irritable-bowel-syndrome/
  2. http://clinicaltrials.eu/trial/study-on-the-effectiveness-and-safety-of-myrrh-coffee-charcoal-and-chamomile-extract-for-patients-with-diarrhea-predominant-or-mixed-type-irritable-bowel-syndrome/