Irritable Bowel Syndrome With DiarrheaPhase 1/2NCT02822118
Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea
A Phase 1/2 study testing Chang'an I Recipe in people with Irritable Bowel Syndrome With Diarrhea, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 5 sites in China.
Trial summary
To evaluate the efficacy and safety of TCM decoction Chang'an I Recipe in the treatment of IBS-D. A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome With Diarrhea
- What is being tested?
- Chang'an I Recipe
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 5 sitesChina
- Study dates
- Jan 2013to May 2016
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meeting the diagnostic criteria of Western medicine for IBS-D;
- aged 18-70 years old; with a baseline IBS-SSS score over 75 points;
- voluntarily signed the informed consent;
- local resident who could ensure follow-ups, with basic reading ability.
Who cannot join
- Patients with IBS-C, -M, and uncertain forms;
- accompanied with serious lesions in major organs including heart, liver, and kidney, hematopoietic system diseases, and tumors;
- gastrointestinal organic disease (e.g., chronic pancreatitis), or systemic diseases affecting the digestive tract motion (e.g., hyperthyroidism, diabetes, chronic renal insufficiency, and nervous system diseases);
- undergoing or requiring constant use of drugs that may affect gastrointestinal functions (e.g., anti-cholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonist, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics, and intestinal flora regulating drugs);
- with history of abdominal surgery (e.g., cholecystectomy);
- with an allergy history of tested drugs or severe allergy history of food;
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- pregnant and lactating female;
- with a history of neurological or psychiatric disorders;
- or participating in other clinical trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Xiyuan Hospital
Beijing, Beijing Municipality, 100091
Wangjing Hospital
Beijing, Beijing Municipality, 100102
Dongzhimen Hospital
Beijing, Beijing Municipality, 100700
Zhejiang Provincial Hospital of TCM
Hangzhou, Zhejiang, 310006
Longhua Hospital
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial
To evaluate the efficacy and safety of TCM decoction Chang'an I Recipe in the treatment of IBS-D. A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Patients were applied for central random number and were given corresponding treatment according to inclusion sequences.The treatment group was administered the Chang'an I Recipe, 150ml/bag, 3 times/day; while the control group was administered the placebo, 150ml/bag, 3 times/day. Both courses of treatment were 8 weeks.
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Being tested
- Chang'an I Recipe, Placebo
- Keywords
- IBS-D; Chang'an I Recipe; Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chang'an I RecipeDrug
Also called The treatment group
Patients in this group were administered the Chang'an I Recipe, 150ml/bag, 3 times/day for 8 weeks.
PlaceboDrug
Also called The control group
Patients in this group were administered the placebo, 150ml/bag, times/day for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Chang'an I Recipe | Experimental | Patients in this group were administered the Chang'an I Recipe for 8 weeks. Receives: Drug: Chang'an I Recipe |
| Placebo | Placebo comparator | Patients in this group were administered the placebo for 8 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
Score less than 75 points was considered as in remission, 75~175 as mild, 175~300 as moderate, and over 300 as severe.
Measured: IBS-SSS was evaluated by patients at 0, 2, 4 ,6 and 8 weeks.
Secondary outcomes (1)
Serum markers regarding liver and kidney function
Measured: at baseline and 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2016 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel Syndrome With DiarrheaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xudong Tang, Ph.D, Study chair, XiYuan Hospital of China Academy of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822118
- Sponsor's protocol ID
- Digestion-03
- Status last verified
- Jun 2016
- First submitted
- 27 Jun 2016
- Last updated
- 5 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02822118
- Acronym / sponsor ID
- Digestion-03
- Conditions
- Irritable Bowel Syndrome With Diarrhea
- Keywords
- IBS-D; Chang'an I Recipe; Placebo
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Xiyuan Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 4 Jul 2016 (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.
To evaluate the efficacy and safety of TCM decoction Chang'an I Recipe in the treatment of IBS-D. A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Patients were applied for central random number and were given corresponding treatment according to inclusion sequences.The treatment group was administered the Chang'an I Recipe, 150ml/bag, 3 times/day; while the control group was administered the placebo, 150ml/bag, 3 times/day. Both courses of treatment were 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chang'an I Recipe | Experimental | Drug: Chang'an I RecipePatients in this group were administered the Chang'an I Recipe for 8 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPatients in this group were administered the placebo for 8 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients meeting the diagnostic criteria of Western medicine for IBS-D;
- aged 18-70 years old; with a baseline IBS-SSS score over 75 points;
- voluntarily signed the informed consent;
- local resident who could ensure follow-ups, with basic reading ability.
Key exclusion criteria (9 listed)
- Patients with IBS-C, -M, and uncertain forms;
- accompanied with serious lesions in major organs including heart, liver, and kidney, hematopoietic system diseases, and tumors;
- gastrointestinal organic disease (e.g., chronic pancreatitis), or systemic diseases affecting the digestive tract motion (e.g., hyperthyroidism, diabetes, chronic renal insufficiency, and nervous system diseases);
- undergoing or requiring constant use of drugs that may affect gastrointestinal functions (e.g., anti-cholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonist, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics, and intestinal flora regulating drugs);
- with history of abdominal surgery (e.g., cholecystectomy);
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 |
|---|---|---|
| Chang'an I RecipeAlso: The treatment groupPatients in this group were administered the Chang'an I Recipe, 150ml/bag, 3 times/day for 8 weeks. | Drug | Chang'an I Recipe |
| PlaceboAlso: The control groupPatients in this group were administered the placebo, 150ml/bag, times/day for 8 weeks. | Drug | Placebo |
Primary outcome
change of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)
Time frame: IBS-SSS was evaluated by patients at 0, 2, 4 ,6 and 8 weeks.
Score less than 75 points was considered as in remission, 75~175 as mild, 175~300 as moderate, and over 300 as severe.
1 secondary outcome
Serum markers regarding liver and kidney function
Time frame: at baseline and 8 weeks.
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 5 Sep 2016.
- Individual participant dataSharing planned: Yes
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Not yet recruitingPhase 2
Huanghou Zhixie Diwan in the Treatment of Irritable Bowel Syndrome With Diarrhea (IBS-D)
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Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome
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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.
xudong Tang, Ph.D study chair
XiYuan Hospital of China Academy of Traditional Chinese Medicine
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chang'an I Recipe in people with Irritable Bowel Syndrome With Diarrhea, run by Xiyuan Hospital of China Academy of Chinese Medical Sciences at 5 sites 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 9 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 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
change of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) (time frame: IBS-SSS was evaluated by patients at 0, 2, 4 ,6 and 8 weeks.). 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 5 Sep 2016.