ND-12 Combined With H-6 for Adult Chronic Inflammatory Diarrhea
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Second Hospital of Nanjing Medical University
About this trial
This is a randomized controlled trial to explore the efficacy and safety of ND-12 combined with H-6 for patients with chronic inflammatory diarrhea
Eligibility criteria
Qualifiers
Subjects aged 18-75 years (inclusive), of any gender.
Disqualifiers
Fever ≥37.5°C;
Moderate-to-severe dehydration requiring intravenous fluid replacement;
Recurrent vomiting.
Diarrhoea caused by enteric pathogens (e.g., Clostridioides difficile, Salmonella typhi, etc.).
Trial design
Treatments tested in this trial
- mesalazine
- ND-12
- ND-12/H-6
Treatment groups
36 Participants
are divided into 3 treatment groupsSponsors and collaborators
The Second Hospital of Nanjing Medical University
Lead sponsor
Neurodawn Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov