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Not yet recruiting NCT07061184

Fengliao Changweikang for Diarrhea-predominant Irritable Bowel Syndrome: N-of-1 Trial

Phase IV Interventional Irritable Bowel Syndrome - Diarrhoea Traditional Chinese Medicine (TCM) N of 1 Study Design Efficacy and Safety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: FLCWK, Placebo.
Who it may be relevant to
Registry conditions: Irritable Bowel Syndrome - Diarrhoea, Traditional Chinese Medicine (TCM), N of 1 Study Design, Efficacy and Safety. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Efficacy of Fengliao Changweikang Keli for Patients With Diarrhea-predominant Irritable Bowel Syndrome: Study Protocol for a Multicenter, Randomized, Placebo-controlled N-of-1 Trial

Overview

Irritable bowel syndrome with diarrhea (IBS-D) is a functional gastrointestinal disorder, with characteristics of defecation related abdominal pain and diarrhea. Routine treatment strategy for IBS-D is symptom-based with unsatisfactory results, while there is a growing interest in complementary and alternative medicine such as Traditional Chinese Medicine. However, lack of high-quality evidences being the obstacle for its development. This study aims to evaluate the efficacy of Fengliao Changweikang Keli (FLCWK) on symptoms and health-related quality of life in mild to moderate IBS-D patients. After 2-week run-in period, each participant will be randomized to a sequence of six 4-week double-blind treatment periods of FLCWK 8 g three times daily or placebo, separated by 2-week washout periods.

Interventions

  • Drug FLCWK
    FLCWK and matching placebo to be taken in a randomised order for 9 months
  • Drug Placebo
    FLCWK and matching placebo to be taken in a randomised order for 9 months

Primary outcome measures

  • IBS-SSS score [Time frame: At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).]
Secondary outcome measures (2)
  • IBS-QOL score [Time frame: At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).]
  • self-reported symptoms including abdominal pain and diarrhea [Time frame: At the end of run-in period (week 2) and at the end of each washout period (week 8, 14, 20, 26, 32) and during each treatment period (week 6, 12, 18, 24, 30, 36).]

Eligibility criteria

Inclusion criteria

  • Aged between 18 and 75 years.
  • Mild to moderate IBS-D patients, with IBS Severity Scoring System (IBS-SSS) scores of 75 to 300 points\[14\].
  • Ability to complete questionnaires and provide written informed consent.
  • Current use of IBS medications (probiotics, antibiotics, antispasmodic, antidiarrheal and neuromodulators) should be prescribed on a stable dose at least 30 days prior to enrollment, and have no plan to change the dose, diet or lifestyle.
  • Normal blood cell count, liver function, creatinine and urea levels within the last 2 weeks.

Exclusion criteria

  • History of organic gastrointestinal diseases such as inflammatory bowel disease, celiac disease and malignancy.
  • Scores of IBS-SSS > 300 points or IBS-SSS < 75 points.
  • History of severe heart, kidney or liver diseases.
  • Pregnant or breastfeeding.
  • Current alcohol or drug abuse.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT07061184 · I-25PJ1478 · 2022YFC2504006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗