Acute diarrhoea
Conditions
Interventions
Test group:Fengliao Changweikang Keli, boiled water, 1 sachet, 3 times a day
Montmorillonite Powder simulation, poured into 50 mL of warm water, shaking well and then take, 1 sachet, 3 times a day.
Control group:Montmorillonite Powder, poured into 50 mL of warm water, shaken well and taken, 1 sachet at a time, 3 times a day
Fengliao Changweikang Keli simulation, boiled water, 1 sachet at a time, 3 times a day.
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for acute diarrhoea; 2. Meet the TCM diagnostic criteria for diarrhoea - violent ejaculation - damp-heat syndrome; 3. Age 18-65 years old (including endpoint value), gender is not limited; 4. Duration of illness = 3 days; 5. Stool frequency =3 times/day and =10 times/day, with thin or watery, yellowish-brown faeces, without pus and blood; 6. Body temperature <38?; 7. Stool routine WBC =5/HPF, blood routine WBC =10×10^9/L and NEUT% =75%; 8. Have not taken drugs or health products for acute diarrhoea in the last 3 days (the list of drugs or health products is the same as Annex 2); 9. Understand and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Acute diarrhoea caused by bacterial and parasitic infections; 2. Diarrhoea caused by specific pathogens (e.g. cholera, dysentery, typhoid fever), anatomical defects or congenital factors (e.g. malabsorption syndrome), other diseases (e.g. inflammatory bowel disease, endocrine disorders), allergic diarrhoea, irritable bowel syndrome, antibiotic-associated diarrhoea, food poisoning, etc.; 3. Combination of severe dehydration, severe malnutrition or oedema, as well as frequent vomiting that prevents food intake; 4. Combination of serious primary diseases of the heart, liver, kidneys, digestive and haematopoietic systems, etc.; 5. History of diabetes mellitus and random blood glucose =11.1 mmol/L before enrolment; or no previous history of diabetes mellitus and random blood glucose =11.1 mmol/L before enrolment and diagnosed with diabetes mellitus; 6. Allergy to the study drug and its components; 7. Women of childbearing age who are pregnant, breastfeeding, planning to have a child within six months, and unable to use effective contraception during the trial period; 8. Those who have regularly taken Feng Polygonum Gastrointestinal Kang Granules or Chinese herbal tonics or proprietary Chinese medicines with similar therapeutic effects within the last 3 days.; 9. Those who have participated in other clinical trials within the last 3 months; 10. Those deemed by the investigator to be unsuitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diarrhoea efficiency at 5 days post-dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diarrhoea efficiency at 1 day after use of the dru;Diarrhoea efficiency at 3 days after use of the drug;Duration of diarrhoea (h);Time to stop diarrhoea onset (h);Disappearance rate of secondary symptoms at 1, 3 and 5 days;Chinese medicine symptom score; | — |
Countries
China
Contacts
Public ContactTang Xudong
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed