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Not yet recruitingNCT07534995Updated Apr 27, 2026

A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Trial

A Phase 3 interventional study of the Shouhui Tongbian Capsule and Lactulose in OIC, sponsored by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine. Not yet recruiting. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-04-27.

Sponsored by First Teaching Hospital of Tianjin University of Traditional Chinese Medicine · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
270
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study summary

This study intends to design and conduct a prospective, multicenter, randomized, parallel-controlled, superiority trial to evaluate the symptom-relieving effects of Shouhui Tongbian Capsule on opioid-induced constipation (OIC) in cancer patients, including defecation frequency, stool consistency, symptom scores, quality of life and other indicators, and to systematically observe its safety in clinical application. Through analysis of intestinal flora, the mechanism of Shouhui Tongbian Capsule in regulating intestinal function will be revealed. By screening the optimal population for Shouhui Tongbian Capsule in the treatment of OIC, evidence will be provided for optimizing individualized medication.

The primary efficacy endpoint is the proportion of responders at week 2 of treatment, defined as an increase of ≥1 in the average weekly number of spontaneous bowel movements (SBMs) compared with baseline and at least one SBM during that week. Secondary endpoints include weekly number of SBMs, weekly number of complete spontaneous bowel movements (CSBMs), Bristol Stool Form Scale score, straining score, Patient Assessment of Constipation-Symptoms (PAC-SYM) score, and Patient Assessment of Constipation-Quality of Life (PAC-QOL) score.

Safety endpoints mainly include the incidence of adverse events and changes in vital signs, electrocardiography, routine blood and urine tests, as well as liver and renal function before and after treatment. Meanwhile, based on clinical study data, the characteristics of the optimal population for Shouhui Tongbian Capsule in treating OIC will be identified to further enrich the application scenarios of this capsule for OIC.

02

Conditions studied

  • OIC
03

In context

Lead sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine is the lead sponsor of 15 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Must meet the diagnostic criteria for **opioid-induced constipation (OIC) according to the Rome IV Criteria**.
  2. Patients enrolled in the trial must have a history of OIC symptoms for at least 1 week.
  3. Patients must be aged ≥ 18 years and ≤ 85 years.
  4. Patients must have stable cancer status with a of more than 6 months.
  5. Patients must have an (ECOG) performance status of 0-2.
  6. Patients must be on a relatively stable maintenance regimen of opioids, including a daily morphine-equivalent dose of 30 mg to 1000 mg for at least 2 weeks prior to the screening period. In addition, opioid therapy is expected to continue for at least 10 weeks.
  7. Patients must have a spontaneous bowel movement (SBM) frequency of ≤ 2 times per week without laxative use.
  8. Patients must be able to take medications, food, and fluids orally.
  9. Voluntarily participate in the trial and have signed the form.
  10. No use of any prokinetic agents for at least 1 week prior to randomization.

Exclusion criteria

Exclusion Criteria:

  1. Patients diagnosed with defecation disorders at enrollment caused by structural abnormalities of the gastrointestinal tract and other gastrointestinal-related tissues (excluding OIC): inflammatory bowel disease, rectal prolapse, gastrointestinal obstruction, peritoneal or peritoneal tumors.
  2. Patients with a history of gastrointestinal surgery, abdominal surgery or abdominal adhesions within 1 month before screening; or a history of intestinal obstruction within 3 months before screening.
  3. Diagnosis of active diverticular disease; or severe hemorrhoids; or anal fissure; or artificial rectum or anus.
  4. Patients with intra-abdominal catheters or feeding tubes.
  5. Diagnosis of pelvic diseases considered to significantly affect intestinal transit of feces (e.g., uterine prolapse ≥ grade 2, uterine fibroids [located posteriorly with diameter ≥ 5 cm] affecting defecation).
  6. Patients who received a new chemotherapy regimen never used before within 14 days after screening, or who planned to receive such treatment during the study period.
  7. Patients who received radiotherapy within 28 days after screening or planned to receive such treatment during the study period.
  8. Patients who underwent surgery or intervention considered to significantly affect gastrointestinal function within 28 days after screening, or planned to undergo such surgery or intervention during the study period, or planned to undergo surgery or intervention expected to prevent completion of the trial.
  9. Patients with uncontrolled hyperthyroidism, severe hypertension, heart disease, systemic infection or coagulation disorders (hypercoagulable state or bleeding tendency) at study enrollment.
  10. Patients who took >4 additional opioid doses per day for breakthrough pain for more than 3 days during the baseline period, or who modified the maintenance opioid dosing regimen during this period.
  11. Patients with severe cancer pain unresponsive to opioid therapy at regular doses and frequencies (e.g., typical mean daily pain intensity rating of 7 to 10 on the Numerical Rating Scale (NRS; 0 [no pain] to 10 [worst possible pain])).
  12. Patients with a history of opioid discontinuation due to serious adverse events, or for whom opioid discontinuation is anticipated due to potential risk of adverse events.
  13. Patients treated with opioid receptor antagonists within 1 month before screening.
  14. Unconsciousness, psychosis, or inability to express subjective symptoms.
  15. Patients who have participated in or are participating in other clinical trials within the past 3 months.
  16. Other patients considered ineligible for the study by the investigator based on concomitant treatments and medical findings.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
270 participants (estimated)

Study arms

  • Experimental
    the Shouhui Tongbian Capsule group

    Drug: the Shouhui Tongbian Capsule

  • Active comparator
    the lactulose group

    Drug: Lactulose

Interventions

  • Drugthe Shouhui Tongbian Capsule

    Administered orally: Shouhui Tongbian Capsule (specification: 0.35 g per capsule), 2 capsules each time, 3 times daily

  • Lactulose Oral Solution (specification: 100mL: 66.7 g), administered orally, 15 mL each time, twice daily.

06

What researchers measure

Primary outcomes

  1. SBM

    Responders were defined as having at least three spontaneous bowel movements (SBMs) per week and an increase of at least one SBM from baseline for at least 6 out of the 8 treatment weeks. An SBM was defined as a bowel movement occurring within the preceding 24 hours without any medications or interventions to facilitate defecation. Bowel movements occurring within 24 hours of using rescue laxatives or other adjunctive defecation methods were not considered SBMs.

    Time frame: 2 weeks

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for May 2026; primary completion for Dec 2027, 19 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 10, 2026
First posted
Apr 16, 2026
StartEst.
May 30, 2026
Primary completionEst.
Dec 30, 2027
CompletionEst.
Dec 30, 2027
Last update
Apr 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07534995
Lead sponsor
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Responsible party
Kong Fanming (Professor, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine) — Principal investigator
First posted
Apr 16, 2026
Start date
May 30, 2026 (estimated)
Primary completion
Dec 30, 2027 (estimated)
Completion
Dec 30, 2027 (estimated)
Last update
Apr 27, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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