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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
mesalazine
DrugTake 4 melesalazine capsules each time, 3 times a day. Continue for 14 days.
ND-12
DrugTake 1 ND-12 capsule and 3 blank capsules each time, 3 times a day. Continue for 14 days
ND-12/H-6
DrugTake 1 ND-12 capsule and 3 H-6 capsules each time, 3 times a day. Continue for 14 days
Treatment groups
36 Participants
are divided into 3 treatment groupsGroup A: MesalazineExperimental treatment 1 intervention
Group B: ND-12Experimental treatment 1 intervention
Group C: ND-12/H-6Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fecal calprotectin of patients 14 days after treatment compared to the baseline level
The rate of change in fecal calprotectin levels of the subjects at 14 days compared to the baseline level
Time frame
baseline, 14 days post-drug administrationSecondary outcomes
1
The proportion of subjects who achieved a clinical response on the 14th day
The proportion of subjects who achieved a clinical response on the 14th day(Fecal calprotectin decreased by ≥50% compared to the baseline or returned to normal \<150 μg/g)
Time frame
14 days post-drug administration2
The proportion of subjects achieving deep remission on the 14th day
The proportion of subjects achieving deep remission on the 14th day (Fecal calprotectin \< 100 μg/g)
Time frame
14 days post-drug administration3
Serum inflammatory factors after treatment
The changes in inflammatory factors (IL-1β, IL-10, TNF-α) in the blood of the subjects at 14 days compared to the baseline level
Time frame
baseline, 14 days post-drug administration4
The frequency of defecation after treatment
The situation of the subjects' defecation frequency on the 7th, 14th, and 28th days compared to the baseline;
Time frame
baseline, 7 days post-drug administration, 14 days post-drug administration, and 28 days post-drug administrationSponsors and contacts
Click on the lead sponsor to view all of their trials.
The Second Hospital of Nanjing Medical University
Lead sponsor
Neurodawn Pharmaceutical Co., Ltd.
Collaborator
Source ClinicalTrials.gov