Pinaverium and Herbs for Irritable Bowel Syndrome Treatment: an Onset and Offset Study (PHIBEST)
Study Details
Study Description
Brief 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). 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: TCM (Traditional Chinese medicine) 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. |
Device: Atractylodes
Atractylodes (~10-15g)
Other Names:
Device: Paeonia Lactiflora
Paeonia Lactiflora (~15-30g)
Other Names:
Device: Tangerine Peel
Tangerine Peel (~10g)
Other Names:
Drug: Ledebouriella Root
Ledebouriella Root (~10g)
Other Names:
Drug: Radix codonopsitis
Radix codonopsitis (~10-15g)
Other Names:
Drug: Radix curcumae
Radix curcumae (~10g)
Other Names:
Drug: Fingered citron
Fingered citron (~10g)
Other Names:
Drug: Tuckahoe
Tuckahoe (15g)
Other Names:
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| Active Comparator: Pinaverium
|
Drug: Pinaverium
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.
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| Placebo Comparator: Placebo Placebo is blindly given to patients |
Drug: Placebo
Placebo is blindly given to patients.
|
Outcome Measures
Primary Outcome Measures
- Abdominal pain [2 years]
0 = no pain, 10 worst pain
- Primary endpoint --- vi) Form (appearance) of stool [2 years]
Use Bristol stool scale.
Secondary Outcome Measures
- Frequency of the pain [2 year]
0 = no pain; 1 = 1 pain/day; 2 = 2 pains/day; 3 = 3 pains/day; ................... 9 = 9 pains/day; 10 = ≥ 10 pains/day.
- # of stools per day [2 years]
0 = no stool; 1 = 1 stool/day; 2 = 2 stools/day; 3 = 3 stools/day; ............... 9 = 9 stools/day; 10 = ≥ 10 stools/day.
- Abdominal discomfort [2 years]
0 = no discomfort...... 10 = Worst possible, unbearable unbearable discomfort
- Frequency of discomfort [2 years]
0 = no discomfort; 1 = 1 discomfort/day; 2 = 2 discomforts/day; 3 = 3 discomforts /day; ................... 9 = 9 discomforts/day; 10 = ≥ 10 discomforts/day.
Other Outcome Measures
- IBS global symptom relief [2 years]
IBS global symptom relief was evaluated by each patient at the end of the therapy as "improved", "stayed the same", or "worsened"
- Treatment-emergent adverse effect (TEAE) profiles. [2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 to 70 years old age group, male and female
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In accordance with the above Western medicine Rome III standards.
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In accordance with the above description of Deficient Spleen Qi and Liver Qi Stagnation
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Informed consent for treatment
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No change in appetite during treatments periods
Exclusion Criteria:
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Pregnant or lactation female patients, and Fertility male patients
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Present digestive system disease within current three months
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Take IBS medicines within ten days prior to treatment or during treatment
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Take depression medicine within ten days prior to treatment or during treatment
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Take pain reliever medicine within ten days prior to treatment or during treatment
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Have serious primary heart, liver, kidney, lung and blood system diseases, asthma, and Lung and liver dysfunction patients
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If an emergency occurs; a physician terminates the treatment
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Cannot comply with the rules and cannot cooperate
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine | Nanjing | Jiangsu | China | 210017 |
| 2 | Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine | Nanjing | Jiangsu | China | 210029 |
| 3 | Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University. | Beijing | China | 100050 | |
| 4 | Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University | Shanghai | China | 200240 |
Sponsors and Collaborators
- Macrohard Institute of Health
Investigators
- Principal Investigator: Baiwen Li, MD, Department of Gastroenterology, Shanghai First People's Hospital, Shanghai Jiao Tong University, 100 Haining Rd. Hongkou, Shanghai 200280, China.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- D00320141210