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Efficacy and safety of Sishen Granules in the treatment of patients with diarrhea-predominant irritable bowel syndrome and functional diarrhea: a randomized, double-blind, placebo-controlled trial

Efficacy and safety of Sishen Granules in the treatment of patients with diarrhea-predominant irritable bowel syndrome and functional diarrhea: a randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096863
Enrollment
Unknown
Registered
2025-02-07
Start date
2024-02-27
Completion date
Unknown
Last updated
2025-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diarrhea-predominant irritable bowel syndrome&

Interventions

SSG Group:Sishen granules 5g/ packet, 1 packet each time, once a day for 2 weeks.
Placebo group:Placebo was administered 1 packet once a day for 2 weeks

Sponsors

Tianjin Xiqing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-75 years old; (2) Meet the diagnostic criteria of IBS-D and FDr; (3) TCM syndrome differentiation is spleen-kidney Yang deficiency syndrome; (4) The general situation is good; Within 3 months, the blood, urine, stool routine (-), liver and kidney function was normal. (5) The subject fully understands the research content and signs the informed consent.

Exclusion criteria

Exclusion criteria: (1) Previously diagnosed celiac disease, inflammatory bowel disease, bowel cancer or bowel resection, other gastrointestinal diseases that cause diarrhea, unexplained weight loss, or rectal bleeding; (2) The use of probiotic supplements, intestinal adsorbents, slow-release drugs, analgesics or powerful opioids; (3) Patients receiving stable doses of antidepressants for less than 6 weeks; (4) Pregnant women, lactating women or women of childbearing age who have fertility requirements; (5) Mental patients, or cognitive dysfunction; (6) Patients with active infections, inflammatory diseases, hematological disorders and/or malignancies, and chronic kidney and liver diseases; (7) Drug allergy; (8) History of alcohol or drug abuse; (9) The investigator considers that there are other circumstances that are not suitable for participation in the trial.

Design outcomes

Primary

MeasureTime frame
Abdominal pain daily response;Daily response to diarrhea;The Patient Health Questionnaire 12 Somatic Symptom scale;Evaluation of Traditional Chinese Medicine Syndrome Efficacy;

Secondary

MeasureTime frame
Blood routine examination;Urine routine ;Liver function test;Kidney function test;Stool consistency and frequency;Abdominal distension and urgency score;IBS symptom severity scale;Irritable Bowel Syndrome-Quality of Life Measure;

Countries

China

Contacts

Public ContactLi Hai

Tianjin Xiqing Hospital

15202265600@163.com+86 152 0226 5600

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026