Diarrhea-predominant Irritable Bowel SyndromePhase 2/3NCT02538692
Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome
A Phase 2/3 study testing Tong-Xie-Yao-Fang in people with Diarrhea-predominant Irritable Bowel Syndrome, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to test the efficacy and safety of a traditional Chinese medication Tong-Xie-Yao-Fang for patients with diarrhea-predominant irritable bowel Syndrome (IBS-D). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diarrhea-predominant Irritable Bowel Syndrome
- What is being tested?
- Tong-Xie-Yao-Fang
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Dec 2015to Mar 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed as IBS according to the Rome III criteria;
- Diarrhea was present for at least 75% of the time;
- With a TCM differentiation as "liver stagnation and spleen defficiency"
- Had a colonoscopy within a year to rule out other bowel diseases.
Who cannot join
- Organic gastrointestinal disease, such as colorectal cancer, inflammatory bowel disease, advanced colonic polyp;
- Had gastrointestinal surgery within a year;
- Used durgs that affect gastrointestinal motility;
- Had psychological disorder;
- Serious disease in other system, which may bias the outcome measures.
Trial locations and contacts
1 site in 1 country.
China1 site
Teaching Hospital of Chengdu University of TCM
Chengdu, Sichuan, 610075
About this study
Official title: Traditional Chinese Medicine Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome: a Randomized Placebo-controlled Trial and a Mechanistic Study
The purpose of this study is to test the efficacy and safety of a traditional Chinese medication Tong-Xie-Yao-Fang for patients with diarrhea-predominant irritable bowel Syndrome (IBS-D).
Read the detailed description
Participants: The sample size of this trial is 118, to test an odds ratio of 3.5 at a significance of 0.05 and power of 0.8.
Intervention: Tong-Xie-Yao-Fang versus placebo Data collection: Standard operation procedure will be developed for how to interviewing the participants, how to use the IBS diary, how to enter the data into the electronic case report forms.
- Being tested
- Tong-Xie-Yao-Fang, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tong-Xie-Yao-FangDrug
Also called Tongxieyaofang
Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management.
PlaceboDrug
The placebo is the same as Tong-Xie-Yao-Fang in appearance.
| Study group | Role | What they receive |
|---|---|---|
| Tong-Xie-Yao-Fang | Experimental | Tong-Xie-Yao-Fang is a classic formula of traditional Chinese medicine for IBS-D. It is composed of 4 herbs: Radix Paeoniae Alba, Ledebouriella seseloides Wolff, pericarpium citri reticulatae and Rhizoma Atractylodis Macrocephalae. The granules will be administrated for thrice daily at a dose of 15g per time. The total duration of treatment is 4 weeks. Receives: Drug: Tong-Xie-Yao-Fang |
| Placebo | Placebo comparator | It is a placebo that made with similar appearance and taste as the Tong-Xie-Yao-Fang granules. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients who had adequate relief of global IBS-D symptoms for at least 2 of the 4 weeks.
Measured: 4 weeks after initiation of treatment
Secondary outcomes (3)
Stool frequency per week
Measured: baseline(week 0), week 4, week 8, week 12
An visual scale rating the degree of IBS-D symptoms
The scale ranges from 0 to 10. The score 0 indicates the mildest degree, while the 10 indicates the most serious degree.
Measured: baseline(week 0), week 4, week 8, week 12
Proportion of adverse events
Measured: week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2015 (estimated)
- Study startDec 2015
- Primary completionJan 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diarrhea-predominant Irritable Bowel SyndromeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02538692
- Sponsor's protocol ID
- 81373644
- Status last verified
- Apr 2017
- First submitted
- 30 Aug 2015
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen M, Tang TC, Wang Y, Shui J, Xiao XH, Lan X, Yu P, Zhang C, Wang SH, Yao J, Zheng H, Huang DQ. Randomised clinical trial: Tong-Xie-Yao-Fang granules versus placebo for patients with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2018 Jul;48(2):160-168. doi: 10.1111/apt.14817. Epub 2018 Jun 1.
PubMed 29856472
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Chinese Medicine Tong-Xie-Yao-Fang Granules for Diarrhea-predominant Irritable Bowel Syndrome: a Randomized Placebo-controlled Trial and a Mechanistic Study
- ClinicalTrials.gov ID
- NCT02538692
- Acronym / sponsor ID
- 81373644
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Chengdu University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 2 Sep 2015 (estimated)
- 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.
The purpose of this study is to test the efficacy and safety of a traditional Chinese medication Tong-Xie-Yao-Fang for patients with diarrhea-predominant irritable bowel Syndrome (IBS-D).
Detailed description
Participants: The sample size of this trial is 118, to test an odds ratio of 3.5 at a significance of 0.05 and power of 0.8.
Intervention: Tong-Xie-Yao-Fang versus placebo Data collection: Standard operation procedure will be developed for how to interviewing the participants, how to use the IBS diary, how to enter the data into the electronic case report forms.
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 |
|---|---|---|
| Tong-Xie-Yao-Fang | Experimental | Drug: Tong-Xie-Yao-FangTong-Xie-Yao-Fang is a classic formula of traditional Chinese medicine for IBS-D. It is composed of 4 herbs: Radix Paeoniae Alba, Ledebouriella seseloides Wolff, pericarpium citri reticulatae and Rhizoma Atractylodis Macrocephalae. The granules will be administrated for thrice daily at a dose of 15g per time. The total duration of treatment is 4 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboIt is a placebo that made with similar appearance and taste as the Tong-Xie-Yao-Fang granules. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being diagnosed as IBS according to the Rome III criteria;
- Diarrhea was present for at least 75% of the time;
- With a TCM differentiation as "liver stagnation and spleen defficiency"
- Had a colonoscopy within a year to rule out other bowel diseases.
Key exclusion criteria (5 listed)
- Organic gastrointestinal disease, such as colorectal cancer, inflammatory bowel disease, advanced colonic polyp;
- Had gastrointestinal surgery within a year;
- Used durgs that affect gastrointestinal motility;
- Had psychological disorder;
- Serious disease in other system, which may bias the outcome measures.
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 |
|---|---|---|
| Tong-Xie-Yao-FangAlso: TongxieyaofangTong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management. | Drug | Tong-Xie-Yao-Fang |
| PlaceboThe placebo is the same as Tong-Xie-Yao-Fang in appearance. | Drug | Placebo |
Primary outcome
the proportion of patients who had adequate relief of global IBS-D symptoms for at least 2 of the 4 weeks.
Time frame: 4 weeks after initiation of treatment
3 secondary outcomes
Stool frequency per week
Time frame: baseline(week 0), week 4, week 8, week 12
An visual scale rating the degree of IBS-D symptoms
Time frame: baseline(week 0), week 4, week 8, week 12
Proportion of adverse events
Time frame: week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
- Derived from this study: PubMed 29856472Chen M, Tang TC, Wang Y, Shui J, Xiao XH, Lan X, Yu P, Zhang C, Wang SH, Yao J, Zheng H, Huang DQ. Randomised clinical trial: Tong-Xie-Yao-Fang granules versus placebo for patients with diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2018 Jul;48(2):160-168. doi: 10.1111/apt.14817. Epub 2018 Jun 1.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tong-Xie-Yao-Fang in people with Diarrhea-predominant Irritable Bowel Syndrome, run by Chengdu University of Traditional Chinese Medicine at 1 site in China.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of patients who had adequate relief of global IBS-D symptoms for at least 2 of the 4 weeks. (time frame: 4 weeks after initiation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02538692, which also lists 1 linked publication.
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 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.