Trial Registered

Chinese herbal formula enters Phase 2 test for IBS-D in China

Lei Yunshang Group registers a randomized, double-blind Phase 2 trial of the traditional formula Huanghou Zhixie Diwan, entering a China-heavy IBS-D field with no approved drugs yet cleared for the disease there.

Lei Yunshang Group registered a randomized, double-blind Phase 2 trial (NCT07721012) testing the oral traditional Chinese medicine formula Huanghou Zhixie Diwan against a matched comparator in 120 adults with diarrhea-predominant irritable bowel syndrome (IBS-D) in China.

By AppliedXLJuly 22, 2026Trial NCT07721012

Executive Summary

Lei Yunshang Group has registered a Phase 2, randomized, double-blind trial testing an oral traditional Chinese medicine formula in adults with diarrhea-predominant irritable bowel syndrome, with sites in China.
The trial is built around a defined weekly responder threshold combining abdominal pain reduction and stool-consistency improvement, a composite that lets the readout be judged against a clear bar rather than a vague symptom impression.
IBS-D has no drug in this dataset holding the same target as the new formula; the closest comparators are other small-molecule and prebiotic programs tested on distinct mechanisms, and one approved option, eluxadoline, is scoped to opioid-receptor activity rather than the traditional-medicine approach here.
Because the study has not started enrolling, the trial establishes design and intent now, with the actual responder rate the first thing a future readout will need to show.

The trial

The study, listed under NCT07721012, will test Huanghou Zhixie Diwan against a comparator arm in patients diagnosed with IBS-D under Rome IV criteria and, distinctively, under a traditional Chinese medicine syndrome pattern called Large Intestinal Damp-heat. It has not yet started recruiting, with a start date of July 31, 2026, and enrollment set at 120 participants across sites in China. The design is randomized with double masking and two arms, a structure that can support a controlled read on efficacy rather than an open-label impression. NCT07721012

The endpoint bar

The primary outcome measures the proportion of patients who achieve, for at least half the four-week treatment period, both a 30% reduction from baseline in weekly average abdominal pain and a 50% reduction in the number of days per week with Type 6 or 7 stool consistency on the Bristol Stool Scale. That composite bar mirrors the standard regulatory framework used in prior IBS-D programs and gives the eventual readout a defined pass/fail threshold rather than a soft symptom summary. Secondary measures track IBS Symptom Severity Score, a TCM syndrome score requiring a 30% reduction to count as clinically effective, and daily pain and stool frequency changes through eight weeks after treatment ends. NCT07721012

The competitive setting

The IBS-D field carries eight trials using small-molecule interventions, and none in this set share the new formula's target or mechanism, since that mechanism is not characterized. The nearest comparators by modality are AbbVie's eluxadoline, a peripheral opioid-receptor agent already in a Phase 2 pediatric IBS-D study and a Phase 3 study tracking toward December 2032, and Tasly Pharmaceutical's Changkang Granules, another Chinese herbal formula in a Phase 3 IBS-D-predominant-diarrhea trial completing around November 2026. Dicyclomine, an antispasmodic, and lubiprostone, a chloride-channel activator with an on-label irritable bowel syndrome with constipation indication, are approved for IBS-related conditions in the United States, but neither is approved for IBS-D itself and lubiprostone's approved use runs to the constipation-predominant form. No drug in this landscape has an approval specific to IBS-D.

The sponsor

Lei Yunshang Group's disclosed pipeline consists of two trials, both listed as not yet recruiting, with this IBS-D study as the only one identified by indication. The trial carries no prior amendment history beyond its initial registration and no enrollment or timeline changes on record, consistent with a newly filed study. NCT07721012

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