Irritable Bowel Syndrome
Conditions
Keywords
Irritable bowel syndrome,, Pinaverium, Herbal medication for IBS,, Tong Xie Yao Fang (Formula for pain and diarrhea)
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.
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.
Interventions
DRUGPinaverium
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.
DEVICEAtractylodes
Atractylodes (\ 10-15g)
DEVICEPaeonia Lactiflora
Paeonia Lactiflora (\ 15-30g)
DEVICETangerine Peel
Tangerine Peel (\ 10g)
Ledebouriella Root (\ 10g)
Radix codonopsitis (\ 10-15g)
DRUGRadix curcumae
Radix curcumae (\ 10g)
DRUGFingered citron
Fingered citron (\ 10g)
DRUGTuckahoe
Tuckahoe (15g)
DRUGPlacebo
Placebo is blindly given to patients.
Sponsors
Macrohard Institute of Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abdominal pain | 2 years | 0 = no pain, 10 worst pain |
| Primary endpoint --- vi) Form (appearance) of stool | 2 years | Use Bristol stool scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| # 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. |
| 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. |
| Abdominal discomfort | 2 years | 0 = no discomfort...... 10 = Worst possible, unbearable unbearable discomfort |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Outcome results
None listed