ND-12 Combined With H-6 for Adults With Chronic Inflammatory Diarrhea
Tests ND-12 with H-6 in adults with long-lasting inflammatory diarrhea.
Plain-language title generated from the registry record
Registry title: ND-12 Combined With H-6 for Adult Chronic Inflammatory Diarrhea
Key facts
- Where
- Nanjing, ChinaSee the site
- Phase
- Early phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07767370, who can take part
Where in China
- The Second Affiliated Hospital of Nanjing Medical UniversityNanjing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- The Second Hospital of Nanjing Medical University
- Trial code
- NCT07767370
- Record updated
- 17 August 2026
- Original description
This is a randomized controlled trial to explore the efficacy and safety of ND-12 combined with H-6 for patients with chronic inflammatory diarrheaRead full original descriptionShow less
A Randomised, Controlled, Double-blind Exploratory Study of ND-12 Combined With H-6 in the Treatment of Adult Chronic Inflammatory Diarrhea
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
Inclusion: Subjects aged 18-75 years (inclusive), of any gender; Meet any one of the following conditions:; 1） Previously diagnosed ulcerative colitis, currently in the active phase; 2） Diagnosis of chronic diarrhoea: stool frequency ≥3 times per day or markedly higher than the subject's usual baseline; disease duration >4 weeks; recurrent diarrhoea with an interval of 2-4 weeks between episodes; loose stools (Bristol Stool Form Scale type 5, 6, or 7); Faecal calprotectin >150 μg/g. 4.The subject or their legal representative provides informed consent by voluntarily signing the informed consent form, fully understands the study objectives, maintains effective communication with investigators, and is capable of understanding and complying with all requirements specified in this study protocol.
Exclusion: Suspected drug-induced diarrhoea (e.g., long-term use of laxatives, antibiotics, chemotherapeutic agents, etc.) where discontinuation of the offending drug is not feasible; Anticipated need for prohibited medications during the study (e.g. antibiotics, antidiarrhoeals, antiemetics, antispasmodics, etc.); Use of any investigational drug within 30 days prior to enrolment into this study; Other gastrointestinal exclusion criteria; Underlying diseases that may trigger diarrhoea, including hyperthyroidism, gastrointestinal autonomic nervous dysfunction, gastrointestinal malignancy, Crohn's disease, history of colectomy (appendectomy, haemorrhoid surgery and fistula-in-ano surgery excluded), history of small-bowel resection (>20 cm of resected intestinal segment), etc; Drug-related exclusion criteria; History of allergy to any component of mesalazine capsules, ND-12 capsules or H-6 capsules; History of gastrectomy or vagotomy; Known malabsorptive disorders include coeliac disease; Any suspected condition requiring abdominal surgery. Other exclusion criteria; Confirmed human immunodeficiency virus (HIV) positive status, known or suspected immunosuppression; Known severe hepatic or renal insufficiency; Past or current history of alcohol abuse and/or known substance abuse (cocaine, heroin, cannabis, etc.); Any psychiatric condition impairing the subject's ability to understand the nature, scope and potential consequences of the study, and/or documented evidence of non-cooperation; Presence of any of the following symptoms:; 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.); Known lactose intolerance; Pregnant or lactating women.