Irritable Bowel SyndromeNCT02330029
Pinaverium and Herbs for Irritable Bowel Syndrome Treatment: an Onset and Offset Study (PHIBEST)
A study testing Pinaverium, Atractylodes and Paeonia Lactiflora in people with Irritable Bowel Syndrome, run by Macrohard Institute of Health at 4 sites in China.
Trial summary
The purpose of this study is to test the onset of action, offset of action, efficacy, and safety of pinaverium and an herbal medication for irritable bowel syndrome (IBS) for a long term (over one year). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Pinaverium, Atractylodes and Paeonia Lactiflora
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 4 sitesChina
- Study dates
- Aug 2012to May 2017
- Phase
- Interventional
- 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
- 18 to 70 years old age group, male and female
- In accordance with the above Western medicine Rome III standards.
- In accordance with the above description of Deficient Spleen Qi and Liver Qi Stagnation
- Informed consent for treatment
- No change in appetite during treatments periods
Who cannot join
- Pregnant or lactation female patients, and Fertility male patients
- Present digestive system disease within current three months
- Take IBS medicines within ten days prior to treatment or during treatment
- Take depression medicine within ten days prior to treatment or during treatment
- Take pain reliever medicine within ten days prior to treatment or during treatment
- Have serious primary heart, liver, kidney, lung and blood system diseases, asthma, and Lung and liver dysfunction patients
- If an emergency occurs; a physician terminates the treatment
- Cannot comply with the rules and cannot cooperate
Trial locations and contacts
4 sites in 1 country.
China4 sites
Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.
Beijing, 100050
Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
Nanjing, Jiangsu, 210017
Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
Nanjing, Jiangsu, 210029
Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University
Shanghai, 200240
About this study
Official title: A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome
The purpose of this study is to test the onset of action, offset of action, efficacy, and safety of pinaverium and an herbal medication for irritable bowel syndrome (IBS) for a long term (over one year). Pinaverium has been in many countries, but there is no randomized, double-blind, large sample size, and placebo-controlled study on this medication yet. Tong Xie Yao Fang (Formula for pain and diarrhea) is a historically and contemporarily used traditional Chinese medicine that can be used for IBS. The hypothesis is that the two remedies are effective and safe for IBS treatment with no significant different onset and offset of actions when tested by modern clinical standards and criteria.
Read the detailed description
Pinaverium bromide (pinaverium), an antispasmodics, is one of the most commonly used IBS medication worldwide. However, original clinical studies on pinaverium are scarce. Only five original clinical studies from Europe, one from Latin America, and one from Asian were found. These studies were single-centered and small sample sized (19 - 53 IBS patients) studies.
Tong Xie Yao Fang has long been used in China. Its efficacy and safety has not been evaluated by modern scientific method.
Effectiveness, onset and offset of actions are the most considered factors when physicians choose medications for IBS. Yet, to our knowledge, there are no clinical studies studied the onset and offset of actions of pinaverium, which remains one of the most transcribed IBS medications, and herbs, which are becoming more popular for treating IBS.
This study is designed to evaluate onset and offset of actions, efficacy, and safety over a long term (>1 year) of pinaverium and Tong Xie Yao Fang for IBS treatment in a double-blind, randomized, and large sample size clinical trial using placebo as a control.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Pinaverium, Atractylodes, Paeonia Lactiflora, Tangerine Peel, Ledebouriella Root
- Keywords
- Irritable bowel syndrome,, Pinaverium, Herbal medication for IBS,, Tong Xie Yao Fang (Formula for pain and diarrhea)
- Medical subject headings
- Irritable Bowel Syndrome, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PinaveriumDrug
To test the effectiveness and safety of the formula for pain and diarrhea, we will randomly assign patients into one 3 groups: Pinaverium, TCM (Formula for pain and diarrhea) group, and placebo group, and treat them accordingly.
AtractylodesDevice
Also called One of active ingredients in TCM group
Atractylodes (~10-15g)
Paeonia LactifloraDevice
Also called One of active ingredients in TCM group
Paeonia Lactiflora (~15-30g)
Tangerine PeelDevice
Also called One of active ingredients in TCM group
Tangerine Peel (~10g)
Ledebouriella RootDrug
Also called One of active ingredients in TCM group
Ledebouriella Root (~10g)
Radix codonopsitisDrug
Also called One of active ingredients in TCM group
Radix codonopsitis (~10-15g)
Radix curcumaeDrug
Also called One of active ingredients in TCM group
Radix curcumae (~10g)
Fingered citronDrug
Also called One of active ingredients in TCM group
Fingered citron (~10g)
TuckahoeDrug
Also called One of active ingredients in TCM group
Tuckahoe (15g)
PlaceboDrug
Placebo is blindly given to patients.
| Study group | Role | What they receive |
|---|---|---|
| TCM (Traditional Chinese medicine) | Active comparator | Formula for pain and diarrhea, Atractylodes (~10-15g), Paeonia Lactiflora (~15-30g), Tangerine Peel (~10g), Ledebouriella Root (~10g), Radix codonopsitis (~10-15g), Radix curcumae (~10g), Fingered citron (~10g), Tuckahoe (~15g), etc. Receives: Device: Atractylodes; Device: Paeonia Lactiflora; Device: Tangerine Peel; Drug: Ledebouriella Root; Drug: Radix codonopsitis; Drug: Radix curcumae; Drug: Fingered citron; Drug: Tuckahoe |
| Pinaverium | Active comparator | Not described Receives: Drug: Pinaverium |
| Placebo | Placebo comparator | Placebo is blindly given to patients Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal pain
0 = no pain, 10 worst pain
Measured: 2 years
Primary endpoint --- vi) Form (appearance) of stool
Use Bristol stool scale.
Measured: 2 years
Secondary outcomes (4)
Frequency of the pain
0 = no pain; 1 = 1 pain/day; 2 = 2 pains/day; 3 = 3 pains/day; ................... 9 = 9 pains/day; 10 = ≥ 10 pains/day.
Measured: 2 year
# of stools per day
0 = no stool; 1 = 1 stool/day; 2 = 2 stools/day; 3 = 3 stools/day; ............... 9 = 9 stools/day; 10 = ≥ 10 stools/day.
Measured: 2 years
Abdominal discomfort
0 = no discomfort...... 10 = Worst possible, unbearable unbearable discomfort
Measured: 2 years
Frequency of discomfort
0 = no discomfort; 1 = 1 discomfort/day; 2 = 2 discomforts/day; 3 = 3 discomforts /day; ................... 9 = 9 discomforts/day; 10 = ≥ 10 discomforts/day.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startAug 2012
- Primary completionNov 2014
- Study completionMay 2017 (estimated)
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Macrohard Institute of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baiwen Li, MD, Principal investigator, Department of Gastroenterology, Shanghai First People's Hospital, Shanghai Jiao Tong University, 100 Haining Rd. Hongkou, Shanghai 200280, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330029
- Sponsor's protocol ID
- D00320141210
- Status last verified
- Nov 2016
- First submitted
- 29 Dec 2014
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zheng L, Lu W, Xiao Q, Lai Y, Fan H, Sun Y, Huang D, Wang Y, Li Z, Jiang Z, Liu X, Zhang L, Zuo D, Shou Z, Tang Q, Huang H, Yang Y, Tang Z, Xiao J. Assessing the post-treatment therapeutic effect of pinaverium in irritable bowel syndrome: a randomized controlled trial. Sci Rep. 2021 Jul 6;11(1):13894. doi: 10.1038/s41598-021-92990-7.
PubMed 34230526
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT02330029
- Acronym / sponsor ID
- D00320141210
- Conditions
- Irritable Bowel Syndrome
- Keywords
- Irritable bowel syndrome,, Pinaverium, Herbal medication for IBS,, Tong Xie Yao Fang (Formula for pain and diarrhea)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Macrohard Institute of HealthUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- May 2017 (estimated)
- First posted
- 1 Jan 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 onset of action, offset of action, efficacy, and safety of pinaverium and an herbal medication for irritable bowel syndrome (IBS) for a long term (over one year). Pinaverium has been in many countries, but there is no randomized, double-blind, large sample size, and placebo-controlled study on this medication yet. Tong Xie Yao Fang (Formula for pain and diarrhea) is a historically and contemporarily used traditional Chinese medicine that can be used for IBS. The hypothesis is that the two remedies are effective and safe for IBS treatment with no significant different onset and offset of actions when tested by modern clinical standards and criteria.
Detailed description
Pinaverium bromide (pinaverium), an antispasmodics, is one of the most commonly used IBS medication worldwide. However, original clinical studies on pinaverium are scarce. Only five original clinical studies from Europe, one from Latin America, and one from Asian were found. These studies were single-centered and small sample sized (19 - 53 IBS patients) studies.
Tong Xie Yao Fang has long been used in China. Its efficacy and safety has not been evaluated by modern scientific method.
Effectiveness, onset and offset of actions are the most considered factors when physicians choose medications for IBS. Yet, to our knowledge, there are no clinical studies studied the onset and offset of actions of pinaverium, which remains one of the most transcribed IBS medications, and herbs, which are becoming more popular for treating IBS.
This study is designed to evaluate onset and offset of actions, efficacy, and safety over a long term (>1 year) of pinaverium and Tong Xie Yao Fang for IBS treatment in a double-blind, randomized, and large sample size clinical trial using placebo as a control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TCM (Traditional Chinese medicine) | Active comparator | Device: Atractylodes, Device: Paeonia Lactiflora, Device: Tangerine Peel, Drug: Ledebouriella Root, Drug: Radix codonopsitis, Drug: Radix curcumae, Drug: Fingered citron, Drug: TuckahoeFormula for pain and diarrhea, Atractylodes (~10-15g), Paeonia Lactiflora (~15-30g), Tangerine Peel (~10g), Ledebouriella Root (~10g), Radix codonopsitis (~10-15g), Radix curcumae (~10g), Fingered citron (~10g), Tuckahoe (~15g), etc. |
| Pinaverium | Active comparator | Drug: Pinaverium |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is blindly given to patients |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 70 years old age group, male and female
- In accordance with the above Western medicine Rome III standards.
- In accordance with the above description of Deficient Spleen Qi and Liver Qi Stagnation
- Informed consent for treatment
- No change in appetite during treatments periods
Key exclusion criteria (8 listed)
- Pregnant or lactation female patients, and Fertility male patients
- Present digestive system disease within current three months
- Take IBS medicines within ten days prior to treatment or during treatment
- Take depression medicine within ten days prior to treatment or during treatment
- Take pain reliever medicine within ten days prior to treatment or during treatment
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 |
|---|---|---|
| PinaveriumTo test the effectiveness and safety of the formula for pain and diarrhea, we will randomly assign patients into one 3 groups: Pinaverium, TCM (Formula for pain and diarrhea) group, and placebo group, and treat them accordingly. | Drug | Pinaverium |
| AtractylodesAlso: One of active ingredients in TCM groupAtractylodes (~10-15g) | Device | TCM (Traditional Chinese medicine) |
| Paeonia LactifloraAlso: One of active ingredients in TCM groupPaeonia Lactiflora (~15-30g) | Device | TCM (Traditional Chinese medicine) |
| Tangerine PeelAlso: One of active ingredients in TCM groupTangerine Peel (~10g) | Device | TCM (Traditional Chinese medicine) |
| Ledebouriella RootAlso: One of active ingredients in TCM groupLedebouriella Root (~10g) | Drug | TCM (Traditional Chinese medicine) |
| Radix codonopsitisAlso: One of active ingredients in TCM groupRadix codonopsitis (~10-15g) | Drug | TCM (Traditional Chinese medicine) |
| Radix curcumaeAlso: One of active ingredients in TCM groupRadix curcumae (~10g) | Drug | TCM (Traditional Chinese medicine) |
| Fingered citronAlso: One of active ingredients in TCM groupFingered citron (~10g) | Drug | TCM (Traditional Chinese medicine) |
| TuckahoeAlso: One of active ingredients in TCM groupTuckahoe (15g) | Drug | TCM (Traditional Chinese medicine) |
| PlaceboPlacebo is blindly given to patients. | Drug | Placebo |
Primary outcome
Abdominal pain
Time frame: 2 years
0 = no pain, 10 worst pain
Primary endpoint --- vi) Form (appearance) of stool
Time frame: 2 years
Use Bristol stool scale.
4 secondary outcomes
Frequency of the pain
Time frame: 2 year
# of stools per day
Time frame: 2 years
Abdominal discomfort
Time frame: 2 years
Frequency of discomfort
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Derived from this study: PubMed 34230526Zheng L, Lu W, Xiao Q, Lai Y, Fan H, Sun Y, Huang D, Wang Y, Li Z, Jiang Z, Liu X, Zhang L, Zuo D, Shou Z, Tang Q, Huang H, Yang Y, Tang Z, Xiao J. Assessing the post-treatment therapeutic effect of pinaverium in irritable bowel syndrome: a randomized controlled trial. Sci Rep. 2021 Jul 6;11(1):13894. doi: 10.1038/s41598-021-92990-7.
Related trials for Irritable Bowel Syndrome
RecruitingObservational study
Abdominal Symptoms and Rosacea: An Observational Study on the Association Between Irritable Bowel Syndrome (IBS) and the Gut-Skin Axis
IBS (Irritable Bowel Syndrome), Rosacea
Recruiting
Stress Reduction and Lifestyle Modification in Irritable Bowel Syndrome Patients
Irritable Bowel Syndrome
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
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.
Baiwen Li, MD principal investigator
Department of Gastroenterology, Shanghai First People's Hospital, Shanghai Jiao Tong University, 100 Haining Rd. Hongkou, Shanghai 200280, China.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pinaverium, Atractylodes and Paeonia Lactiflora in people with Irritable Bowel Syndrome, run by Macrohard Institute of Health at 4 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
Are results available for this study?
Results are not available in the source record.
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?
Abdominal pain (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT02330029, 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 22 Nov 2016.