Acute unspecific diarrhea MedDRA version: 14.1 Level: LLT Classification code 10000706 Term: Acute diarrhea System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Arhama-Tinktur N
Product Name: Arhama-Tinktur N
Product Code: A185
Pharmaceutical Form: Oral solution
CAS Number: 8022-56-8
Other descriptive name: SALVIA OFFICINALIS
Concentration unit: g
Sponsors
Bombastus-Werke AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Acute, uncomplicated diarrhea as a consequence of gastroenteritis Men and women from 18 –70 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 420 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Hemorrhagic diarrhea with severe general symptoms and high fever Bad general condition (apathy, middle to strong exsiccosis) Patients with indication of standardised rehydratation or antibiotic use at screening visit Duration of diarrhea symtoms longer than 48 hours Suspicion of an exacerbation of a known chronic inflammatory bowel disease Suspicion of intestinal cancer Intake of anti-diarrheal agents during the last 8 hours before randomisation Suspicion of parasitical diarrhea Suspicion of hormonal induced diarrhea Severe systemic diseases (e.g. carcinoma) Patients with other severe organic or systemic diseases (e.g. HIV, multiple sclerosis) Patients with severe psychiatric diseases (e.g. major depression, schizophrenic disorder) Pregnancy and nursing Women with child-bearing potential without safe contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Superiority of oral treatment with Arhama®-Tinktur N (7,5 ml oral per 48 hours) compared to placebo;Secondary Objective: Safety and Tolerability of Arhama®-Tinktur N;Primary end point(s): Duration of diarrhea (time form start of medication to last unformed stool);Timepoint(s) of evaluation of this end point: Maximum duration of 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Maximum of 14 days;Secondary end point(s): Total duration of disease (time form first unformed stool to last unformed stool) Responder rate regarding symptoms of diarrhea Responder rate regarding healed patients (no diluted and =<2 unformed stools in the last 24 hours in comparison to 24 hours before randomisation) Rate of patients with aggravation of symptoms at day 2 Rate of patients with persisting symptoms at day 14 Rate of patients with need of standardised rehydratation or antibiotic treatment Change of abdominal pain and/or cramps Change of stool frequency Assessment of treatment success by the investigator Frequency and severity of adverse events Acceptance of study medication by the patient Asseessment of tolarability by the investigator Change of standard laboratory parameters Change of immunological lab parameters | — |
Countries
Germany
Contacts
Public ContactProject manager
CardioSec Clinical Research GmbH
Outcome results
None listed