MYRRH, COFFEE CHARCOAL, DRY EXTRACT FROM CHAMOMILE FLOWER (4-6:1): EXTRACTION SOLVENT: ETHANOL 60% (M/M) for Irritable bowel syndrome with diarrhoea (IBS-D)

Inclusion criteria

• {"criterion_text":"- Patients of both sexes aged ≥ 18 and ≤ 75 years\n- Negative pregnancy test for persons of childbearing potential\n- Confirmed IBS-D diagnosis at visit 1\n- Colon examination (colonoscopy) performed on patients > 55 years of age within the past 5 years prior to participation in the study\n- Stool frequency: Before visit 1 (screening) in the last 7 days on at least 3 days 1 watery bowel movement/day.\n- Assessment of IBS-D symptoms: a) NRS pain > 3 points on visit 1 and visit 2 b) Stool consistency documented by the patient using the Bristol stool form scale on visits 1 and 2\n- Stool samples for testing for the absence of blood in the stool (occult blood test) and the absence of a Clostridioides (formerly Clostridium) difficile infection by means of glutamate dehydrogenase (GDH) ELISA upon inclusion in the study (result available at visit 2)\n- Presence of a declaration of consent signed by the patient\n- Consent that changes in lifestyle and dietary habits during the dietary habits will be avoided for the duration of the study\n- Willingness to keep a patient diary in accordance with the protocol"}

Exclusion criteria

• {"criterion_text":"- Confirmed diagnosis of microscopic colitis, ulcerative colitis or Crohn's disease\n- past or suspected pancreatitis, ileus or gastrointestinal haemorrhage\n- female patients with known endometriosis\n- patients with gastroesophageal reflux disease (GERD) greater than or equal to 2b\n- known or suspected other causes of diarrhoea: coeliac disease, fructose, lactose, lactose, sorbitol intolerance or other intolerances that lead to diarrhoea symptoms diarrhoea\n- patients with malignant diseases or cancer treatments of the gastrointestinal tract in the last the last 5 years, as well as all other areas of the body in the last 2 years before Inclusion in the study with continued risk potential\n- known autoimmune diseases in the area of the gastrointestinal tract\n- immunocompromised patients (patients with organ transplants, patients with known HIV infection, etc.)\n- condition after partial colon resection\n- known diabetes mellitus, type I and/or type II\n- inappropriate medication for known hyper- or hypothyroidism, Hashimoto's thyroiditis or signs of thyroid dysfunction according to the blood values from Visit 1 and at the discretion of the investigator.\n- Confirmed diagnosis of IBS of the constipation subtype (IBS-C), mixed IBS (IBS-M), or undefined IBS (IBS-U) according to Rome IV criteria\n- Hypersensitivity to camomile, other compositae, myrrh, coffee charcoal or any other component of the test medication MYRRHINIL-INTEST® or the placebo\n- patients with the rare hereditary fructose/galactose intolerance, glucose/galactose malabsorption or sucrase malabsorption. malabsorption or sucrase-isomaltase insufficiency\n- diagnosed severe somatic/psychosomatic, neurological and/or psychiatric disorders psychiatric disorders that make it difficult for the patient to make an informed decision about consent to participate in the clinical trial. The judgement is at the discretion of the treating investigator\n- Intake of neuroleptics up to 1 month before the start of the study and during participation in the study\n- Intake of antibiotics within the last 10 days before the start of the study and/or during study participation\n- Intake of systemic corticosteroids up to 1 month before the start of the study and during study participation participation in the study\n- Intake of medication for the treatment of IBS-D (including herbal and probiotic medication) at the time of visit 1 and during participation in the study (with the exception of study medication and emergency medication)\n- Continuous intake of NSAIDs (non-steroidal anti-inflammatory drugs, e.g. ibuprofen) for a period of more than 14 days (with the exception of NSAIDs used as medication to prevent thrombosis [e.g. ASA] or for the treatment of adverse events).\n- Intake of opioids (e.g. morphine, tilidine, tramadol, etc.) up to 1 month before the start of the study and during participation in the study\n- Intake of cardiac glycosides\n- present since the onset of the disease a) Weight loss within the past 6 months (clinically significant, at the discretion of the investigator's judgement) b) Nocturnal symptoms (e.g. abdominal pain, diarrhoea) c) History of 1st degree relatives with colon carcinoma\n- Patients who participated or are participating in other drug trials (screening) 30 days prior to initial enrolment, or have previously participated in the same study (including randomisation)\n- Patients with a medical condition or in a situation which, in the opinion of the investigator, exposes the patient to a significant risk, interfere with the study results or significantly influence the study results\n- Signs or symptoms of an incipient bacterial or viral infection associated with fever (> 38.5 °C)\n- Abnormal laboratory values (clinically significant, i.e. more than threefold deviation of the upper or lower normal limit of the laboratory or significant at the discretion of the investigator)\n- Deviating forms of food intake: a) Need for artificial nutrition b) Use of formula diets c) parenteral nutrition\n- Existing alcohol abuse or abuse of medication or drugs\n- Pregnant women, nursing mothers or persons of childbearing potential who are unable to use a reliable method of contraception (Pearl Index < 1)\n- Legal incapacity and/or other circumstances that prevent the patient from understanding the nature, aim and effects of the study\n- Persons who have been institutionalised on the basis of an official or court order\n- Uncooperative patients\n- If faecal tests were performed in the 6 months prior to inclusion in the study were performed: a) Positive test for blood in faeces except: (Impurities due to haemorrhoids documented by a digital rectal examination or proctoscopy/ Traces of blood due to local irritation caused by frequent defecation (detected by local inspection inspection or a digital rectal examination) b) Positive test for parasites and worm eggs c) Clinically relevant elevated calprotectin levels (> 50 μg/g) in the stool\n- Diagnosed infectious gastroenteritis\n- known abnormalities of the gastrointestinal tract (e.g. megacolon) or known diseases diseases that result in an altered gastrointestinal passage (e.g. colon polyps)\n- functional disorders of the liver or kidneys (serum creatinine, serum AST or ALT at least 3-fold above the specified reference value in the last 12 months before inclusion in the study)\n- patients with known or suspected gallbladder inflammation (cholecystitis), gallstones, bile acid leakage syndrome, obstruction of the bile ducts or other diseases of the gallbladder gallbladder, dysfunction of the sphincter of Oddi or abdominal adhesions"}

Primary endpoints

• {"endpoint_text":"- Efficacy will be assessed by a co-primary endpoint defined by the responder criteria: Responder rate (decrease in abdominal pain by at least 30%, decrease in days with at least one stool of consistency 6 or 7 by at least 50%)","definition_or_measurement_approach":"Responder rate defined by decrease in abdominal pain by at least 30% and decrease in days with at least one stool of consistency 6 or 7 by at least 50%."}

Secondary endpoints

• {"endpoint_text":"- Change in stool frequency in the last 14 days of the treatment phase compared to the 14 days of the screening phase, each measured as the total number of stools. The target parameter is the reduction: Frequency pre-treatment - Frequency post-treatment.","definition_or_measurement_approach":"Measured as total number of stools; reduction computed as pre-treatment frequency minus post-treatment frequency over 14-day windows."}
• {"endpoint_text":"- Number of spontaneous defecations, recorded daily based on the entries in the patient's diary.","definition_or_measurement_approach":"Daily patient diary entries of spontaneous defecations."}
• {"endpoint_text":"- Stool consistency on individual days measured using the Bristol Stool Form Scale, recorded daily in the patient's diary, assessed during visits 1 to 6 at the study center.","definition_or_measurement_approach":"Daily Bristol Stool Form Scale entries in patient diary; assessed at visits 1-6."}
• {"endpoint_text":"- Number of occurrences of the feeling of incomplete defecation, recorded daily in the patient's diary.","definition_or_measurement_approach":"Daily patient diary recording of incomplete evacuation instances."}
• {"endpoint_text":"- Assessment of the severity of IBS-D symptoms using the IBS-Severity Scoring System (IBS-SSS) during visits 1 to 6 (assessed by the patient).","definition_or_measurement_approach":"IBS-SSS questionnaire completed by patient at visits 1-6."}
• {"endpoint_text":"- Occurrence of mucus and/or blood in the stool on individual days, recorded daily in the patient's diary, assessed during visits 1 to 6 at the study center.","definition_or_measurement_approach":"Daily patient diary entries for mucus and/or blood; queried at visits 1-6."}
• {"endpoint_text":"- Determination of quality of life using the IBS-QoL questionnaire during visits 1 to 6 (assessed by the patient).","definition_or_measurement_approach":"IBS-QoL questionnaire completed by patient at visits 1-6."}
• {"endpoint_text":"- Global assessment of efficacy by the investigator and the patient during visits 3 to 6 (4-point scale).","definition_or_measurement_approach":"4-point global efficacy assessment by investigator and patient at visits 3-6."}
• {"endpoint_text":"- Reduced use of rescue medication (Buscopan®) over the period from day 0 to 28 for the treatment of IBS-D symptoms and over the period of treatment phase 2.","definition_or_measurement_approach":"Use of rescue medication (Buscopan®) tracked over day 0-28 and during treatment phase 2; reduction measured versus baseline/expected usage."}
• {"endpoint_text":"- Compliance (amount of study medication consumed) on visits 3 - 6, based on documentation in the patient diary","definition_or_measurement_approach":"Patient diary documentation of medication consumption assessed at visits 3-6."}
• {"endpoint_text":"- Compliance (amount of study medication consumed) via drug accountability at visits 4 and 6","definition_or_measurement_approach":"Drug accountability checks at visits 4 and 6 to determine amount consumed."}
• {"endpoint_text":"- Adverse events (AEs) throughout the course of the study (V2 - V6)","definition_or_measurement_approach":"Collection and reporting of adverse events during visits V2-V6."}
• {"endpoint_text":"- Vital parameters (blood pressure, pulse, body temperature) on V1 - V6","definition_or_measurement_approach":"Measurement of blood pressure, pulse, and body temperature at visits V1-V6."}
• {"endpoint_text":"- Clinical chemistry and haematology on V1, V4 and V6","definition_or_measurement_approach":"Laboratory clinical chemistry and haematology assessments at V1, V4 and V6."}
• {"endpoint_text":"- Assessment of tolerability by investigator and patient at visits 3 - 6","definition_or_measurement_approach":"Investigator and patient assessments of tolerability at visits 3-6."}

Germany

Earliest CTIS Part Ii Submission Date

17-09-2024

Latest Decision Or Authorization Date

13-03-2026

Processing Time Days

542

Number Of Sites

10

Number Of Participants

220

Primary sponsor

Full Name

REPHA GmbH Biologische Arzneimittel

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Contract research organisations

Name

Velocity Clinical Research Germany GmbH

Name

Siteworks GmbH

Third parties

• {"country":"Germany","full_name":"Mediconomics GmbH","duties_or_roles":"1,10,11,2,5,6,7","organisation_type":"Pharmaceutical company"}