ConstipationPhase 3XHRTNCT06740422
Xuanhuang Runtong Tablet in the Treatment of Constipation (Yin-deficiency Type)
A Phase 3 study testing Xuanhuang Runtong Tablet and Xuanhuang Runtong Tablet Simulator in people with Constipation, run by Beijing Hospital of Traditional Chinese Medicine.
Trial summary
This trial is a randomized, double-blind, placebo-controlled parallel-group, multicenter Phase III clinical trial. It is to evaluate the efficacy and safety of Xuanhuang Runtong Tablets in subjects with constipation (Yin-deficiency type) after 4 weeks of treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Constipation
- What is being tested?
- Xuanhuang Runtong Tablet and Xuanhuang Runtong Tablet Simulator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2024to 15 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all of the following inclusion criteria to enter the run-in period:
- Meeting the diagnostic criteria of traditional Chinese medicine (TCM) constipation;
- Meeting the TCM syndrome differentiation criteria of constipation with yin deficiency syndrome;
- Both males and females are eligible, aged between 18 and 70 years old (including 18 and 70);
- Willing to participate in the trial and sign the informed consent form.
- At the end of the run-in period, subjects must meet all of the following criteria to enter the treatment period:
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- Meeting the diagnostic criteria of TCM constipation;
- Meeting the TCM syndrome differentiation criteria of constipation with yin deficiency syndrome;
- The number of spontaneous bowel movements in the last week of the run-in period is less than 3.
Who cannot join
- Subjects with any of the following items cannot enter the run-in period/treatment period:
- Subjects with constipation or severe anal diseases causing defecation disorders diagnosed by researchers due to rectal, colonic organic diseases (such as tumors, inflammatory bowel diseases, intestinal adhesions, colon tuberculosis, etc.);
- Subjects with constipation caused by central nervous system diseases (such as multiple sclerosis, Parkinson's disease, spinal cord injury, etc.) or muscle diseases (such as amyloidosis, dermatomyositis, etc.) known or identified as being caused by drugs;
- Subjects with colonoscopy results showing intestinal polyps > 0.5 cm or quantity > 3 (subjects with removed intestinal polyps are not excluded, but those with tubular adenoma accompanied by high-grade intraepithelial neoplasia or those who need to re-examine colonoscopy in the near future are excluded);
- Subjects who have taken drugs for treating constipation within 1 week before screening or within 5 half-lives (calculated according to the longer time);
- Subjects with severe heart, liver, kidney, brain, blood, metabolic and endocrine system diseases and unstable conditions requiring drug adjustment at any time, and patients with malignant tumors;
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- Subjects who are evaluated by researchers as unable to cooperate with clinical trialists in terms of psychological, mental status or cognitive ability, language expression ability, etc. or have a history of severe mental illness, such as patients with severe depression and severe anxiety.
- Subjects who have had abdominal surgery within 3 months before screening or plan to have abdominal surgery during the trial period;
- Subjects with HbA1c > 8.5% at screening;
- Subjects with ALT or AST ≥ 1.5 times the upper limit of the normal value, or Scr > the upper limit of the normal value;
- Subjects with known or suspected allergies or severe adverse reactions to the components of Xuanhuang Runtong Tablets or Bisacodyl Enteric-coated Tablets, or with an allergic constitution (such as allergies to two or more drugs or foods);
- Subjects who have participated in other clinical trials and taken trial drugs within the past 3 months;
- Subjects with suspected or confirmed history of alcohol or drug abuse;
- Pregnant or lactating women; or female and male subjects of childbearing potential who are unwilling or unable to take effective contraceptive measures during the trial period;
- Subjects with other conditions that researchers consider inappropriate to participate in this trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase Ⅲ Clinical Trial on the Efficacy and Safety of Xuanhuang Runtong Tablet in Treating Constipation (Yin-deficiency Type).
This trial is a randomized, double-blind, placebo-controlled parallel-group, multicenter Phase III clinical trial. It is to evaluate the efficacy and safety of Xuanhuang Runtong Tablets in subjects with constipation (Yin-deficiency type) after 4 weeks of treatment.
- Conditions
- Constipation
- Being tested
- Xuanhuang Runtong Tablet, Xuanhuang Runtong Tablet Simulator
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xuanhuang Runtong TabletDrug
A synthetic tablet is mainly composed of Radix Rehmanniae, Radix Scrophulariae, Radix Angelicae Sinensis, Semen Persicae, Herba Cistanches, Fructus Cannabis, Semen Cassiae, Fructus Aurantii Immaturus and Aloe.
Xuanhuang Runtong Tablet SimulatorDrug
Xuanhuang Runtong Tablet Simulator
| Study group | Role | What they receive |
|---|---|---|
| Xuanhuang Runtong Tablet group | Experimental | Xuanhuang Runtong Tablet, 4 tablets (1.84 g herb per tablet) per dose, three times a day Receives: Drug: Xuanhuang Runtong Tablet |
| Placebo group | Placebo comparator | Xuanhuang Runtong Tablet Simulator, 4 tablets (0 g herb content per bottle) per dose, three times a day Receives: Drug: Xuanhuang Runtong Tablet Simulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Spontaneous Bowel Movement (CSBM) response rate after 4 weeks of treatment.
CSBM: The number of spontaneous bowel movements with a complete sense of evacuation without taking rescue laxatives or with the assistance of manipulation. (Taking rescue medications within 24 hours before defecation is not counted as CSBM).
Weekly response: If a patient has at least 3 CSBMs in a week and an increase of at least 1 CSBM compared to the baseline, it is considered a weekly response.
CSBM response: The patient meets the CSBM weekly response for at least 50% of the weeks during drug treatment (e.g., 3 out of 4 weeks).
Overall CSBM response rate = Number of CSBM responders / Total number of observed patients × 100%.
Measured: Examination will be performed 4 weeks of treatment.
Secondary outcomes (11)
Complete Spontaneous Bowel Movement (CSBM) response rate after 2 weeks of treatment.
Overall CSBM response rate = Number of CSBM responders / Total number of observed patients × 100%.
Measured: Examination will be performed 2 weeks of treatment.
The change in the number of bowel movements (BM) at the last week compared to baseline
The patient recorded the number of BMs every day using a diary card.
Measured: Evaluation will be performed at baseline and 4 weeks of treatment.
The change in the number of spontaneous bowel movements (SBM) at the last week compared to baseline .
The patient recorded the number of SBMs every day using a diary card.
Measured: Evaluation will be performed at baseline and 4 weeks of treatment.
The change in the fecal characteristics score (using the Bristol Stool Form Scale) at the last week compared to baseline.
Bristol Stool Form Scale： Type 1 Separate hard lumps, like nuts. Type 2 Sausage-shaped but lumpy. Type 3 Like a sausage or snake but with cracks on its surface. Type 4 Like a sausage or snake, smooth and soft. Type 5 Soft blobs with clear-cut edges. Type 6 Fluffy pieces with ragged edges, a mushy stool.Type 7 Watery, no solid pieces. The 1-7 types correspond to scores of 1-7 respectively.
Measured: Evaluation will be performed at baseline and 4 weeks of treatment.
The change in the degree of difficulty in passing stools score (using the Likert scale) at the last week compared to baseline.
The Patient Assessment of Constipation Symptoms (PAC-SYM) questionnaire uses a Likert scale grading system for rating the severity of constipation symptoms, which is divided into five levels of severity: 0, 1, 2, 3, and 4.
Measured: Evaluation will be performed at baseline and 4 weeks of treatment.
The proportion of subjects with fecal characteristics of type 4 or 5 in the last spontaneous bowel movement (SBM) during the treatment period.
Calculate the proportion of subjects whose fecal consistency of the last spontaneous bowel movement (SBM) during the treatment period is Type 4 or Type 5 among all subjects.
Measured: Evaluation will be performed at baseline and 4 weeks of treatment.
The changes inTraditional Chinese Medicine (TCM) syndrome scores at the last week compared to baseline.
The TCM syndrome score of constipation consists of 8 questions, and the total scores are ranging from 0 to 24 with higher scores indicating more severe disease.
Measured: Examination will be performed at baseline and 4 weeks of treatment.
Efficacy of TCM syndromes
The efficacy index of TCM syndromes : (pre - treatment score - post - treatment score) / pre - treatment score × 100%. It is divided into four levels: clinical recovery, marked effectiveness, effectiveness, and ineffectiveness.
Measured: Examination will be performed at baseline and 4 weeks of treatment.
The disappearance rate of single symptoms of TCM syndromes
The disappearance rate of single symptoms of TCM syndromes refers to the percentage of the number of cases with a single - symptom score of 0 in each single symptom among the total number of cases (when calculating the denominator, subjects with a single - symptom score of 0 at baseline need to be excluded).
Measured: Examination will be performed at baseline and 4 weeks of treatment.
The use of rescue medication.
Calculate the total number of rescue medication doses taken during the treatment period.
Measured: Examination will be performed 4 weeks of treatment.
Changes in the Patient Assessment of Constipation Quality of Life (PAC-QOL) score compared to baseline at 4 weeks of treatment
Calculate the total PAC-QOL score and the change in scores for the physiological, psychosocial, worries, and satisfaction domains compared to baseline
Measured: Examination will be performed at baseline and 4 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start15 Dec 2024 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shengsheng Zhang, Beijing Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06740422
- Sponsor's protocol ID
- XHRT-Ⅲ-2024
- Acronym
- XHRT
- Status last verified
- Dec 2024
- First submitted
- 10 Dec 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Phase Ⅲ Clinical Trial on the Efficacy and Safety of Xuanhuang Runtong Tablet in Treating Constipation (Yin-deficiency Type).
- ClinicalTrials.gov ID
- NCT06740422
- Acronym / sponsor ID
- XHRT / XHRT-Ⅲ-2024
- Conditions
- Constipation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 15 Dec 2024 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 18 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a randomized, double-blind, placebo-controlled parallel-group, multicenter Phase III clinical trial. It is to evaluate the efficacy and safety of Xuanhuang Runtong Tablets in subjects with constipation (Yin-deficiency type) after 4 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xuanhuang Runtong Tablet group | Experimental | Drug: Xuanhuang Runtong TabletXuanhuang Runtong Tablet, 4 tablets (1.84 g herb per tablet) per dose, three times a day |
| Placebo group | Placebo comparator | Drug: Xuanhuang Runtong Tablet SimulatorXuanhuang Runtong Tablet Simulator, 4 tablets (0 g herb content per bottle) per dose, three times a day |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Meeting the diagnostic criteria of traditional Chinese medicine (TCM) constipation;
- Meeting the TCM syndrome differentiation criteria of constipation with yin deficiency syndrome;
- Both males and females are eligible, aged between 18 and 70 years old (including 18 and 70);
- Willing to participate in the trial and sign the informed consent form.
- At the end of the run-in period, subjects must meet all of the following criteria to enter the treatment period:
Key exclusion criteria (15 listed)
- Subjects with constipation or severe anal diseases causing defecation disorders diagnosed by researchers due to rectal, colonic organic diseases (such as tumors, inflammatory bowel diseases, intestinal adhesions, colon tuberculosis, etc.);
- Subjects with constipation caused by central nervous system diseases (such as multiple sclerosis, Parkinson's disease, spinal cord injury, etc.) or muscle diseases (such as amyloidosis, dermatomyositis, etc.) known or identified as being caused by drugs;
- Subjects with colonoscopy results showing intestinal polyps > 0.5 cm or quantity > 3 (subjects with removed intestinal polyps are not excluded, but those with tubular adenoma accompanied by high-grade intraepithelial neoplasia or those who need to re-examine colonoscopy in the near future are excluded);
- Subjects who have taken drugs for treating constipation within 1 week before screening or within 5 half-lives (calculated according to the longer time);
- Subjects with severe heart, liver, kidney, brain, blood, metabolic and endocrine system diseases and unstable conditions requiring drug adjustment at any time, and patients with malignant tumors;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xuanhuang Runtong TabletA synthetic tablet is mainly composed of Radix Rehmanniae, Radix Scrophulariae, Radix Angelicae Sinensis, Semen Persicae, Herba Cistanches, Fructus Cannabis, Semen Cassiae, Fructus Aurantii Immaturus and Aloe. | Drug | Xuanhuang Runtong Tablet group |
| Xuanhuang Runtong Tablet SimulatorXuanhuang Runtong Tablet Simulator | Drug | Placebo group |
Primary outcome
Complete Spontaneous Bowel Movement (CSBM) response rate after 4 weeks of treatment.
Time frame: Examination will be performed 4 weeks of treatment.
CSBM: The number of spontaneous bowel movements with a complete sense of evacuation without taking rescue laxatives or with the assistance of manipulation. (Taking rescue medications within 24 hours before defecation is not counted as CSBM). Weekly response: If a patient has at least 3 CSBMs in a week and an increase of at least 1 CSBM compared to the baseline, it is considered a weekly response. CSBM response: The patient meets the CSBM weekly response for at least 50% of the weeks during drug treatment (e.g., 3 out of 4 weeks). Overall CSBM response rate = Number of CSBM responders / Total number of observed patients × 100%.
11 secondary outcomes
Complete Spontaneous Bowel Movement (CSBM) response rate after 2 weeks of treatment.
Time frame: Examination will be performed 2 weeks of treatment.
The change in the number of bowel movements (BM) at the last week compared to baseline
Time frame: Evaluation will be performed at baseline and 4 weeks of treatment.
The change in the number of spontaneous bowel movements (SBM) at the last week compared to baseline .
Time frame: Evaluation will be performed at baseline and 4 weeks of treatment.
The change in the fecal characteristics score (using the Bristol Stool Form Scale) at the last week compared to baseline.
Time frame: Evaluation will be performed at baseline and 4 weeks of treatment.
The change in the degree of difficulty in passing stools score (using the Likert scale) at the last week compared to baseline.
Time frame: Evaluation will be performed at baseline and 4 weeks of treatment.
The proportion of subjects with fecal characteristics of type 4 or 5 in the last spontaneous bowel movement (SBM) during the treatment period.
Time frame: Evaluation will be performed at baseline and 4 weeks of treatment.
The changes inTraditional Chinese Medicine (TCM) syndrome scores at the last week compared to baseline.
Time frame: Examination will be performed at baseline and 4 weeks of treatment.
Efficacy of TCM syndromes
Time frame: Examination will be performed at baseline and 4 weeks of treatment.
The disappearance rate of single symptoms of TCM syndromes
Time frame: Examination will be performed at baseline and 4 weeks of treatment.
The use of rescue medication.
Time frame: Examination will be performed 4 weeks of treatment.
Changes in the Patient Assessment of Constipation Quality of Life (PAC-QOL) score compared to baseline at 4 weeks of treatment
Time frame: Examination will be performed at baseline and 4 weeks of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Xuanhuang Runtong Tablet and Xuanhuang Runtong Tablet Simulator in people with Constipation, run by Beijing Hospital of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lu Qing Zhao, Doctor (01087906580, zhaoluqing@bjzhongyi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Spontaneous Bowel Movement (CSBM) response rate after 4 weeks of treatment. (time frame: Examination will be performed 4 weeks of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.