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Pinaverium and Herbs for Irritable Bowel Syndrome Treatment: an Onset and Offset Study (PHIBEST)

Not Applicable
Conditions
Irritable Bowel Syndrome
Interventions
Device: Atractylodes
Drug: Placebo
Drug: Pinaverium
Device: Paeonia Lactiflora
Device: Tangerine Peel
Drug: Ledebouriella Root
Drug: Radix codonopsitis
Drug: Radix curcumae
Drug: Fingered citron
Drug: Tuckahoe
Registration Number
NCT02330029
Lead Sponsor
Macrohard Institute of Health
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
800
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
TCM (Traditional Chinese medicine)Fingered citronFormula 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.
TCM (Traditional Chinese medicine)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.
TCM (Traditional Chinese medicine)Tangerine PeelFormula 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.
TCM (Traditional Chinese medicine)Paeonia LactifloraFormula 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.
TCM (Traditional Chinese medicine)AtractylodesFormula 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.
TCM (Traditional Chinese medicine)Ledebouriella RootFormula 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.
TCM (Traditional Chinese medicine)Radix codonopsitisFormula 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.
TCM (Traditional Chinese medicine)Radix curcumaeFormula 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.
PlaceboPlaceboPlacebo is blindly given to patients
PinaveriumPinaverium-
Primary Outcome Measures
NameTimeMethod
Primary endpoint --- vi) Form (appearance) of stool2 years

Use Bristol stool scale.

Abdominal pain2 years

0 = no pain, 10 worst pain

Secondary Outcome Measures
NameTimeMethod
Frequency of the pain2 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 day2 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 discomfort2 years

0 = no discomfort...... 10 = Worst possible, unbearable unbearable discomfort

Frequency of discomfort2 years

0 = no discomfort; 1 = 1 discomfort/day; 2 = 2 discomforts/day; 3 = 3 discomforts /day; ................... 9 = 9 discomforts/day; 10 = ≥ 10 discomforts/day.

Trial Locations

Locations (4)

Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine

🇨🇳

Nanjing, Jiangsu, China

Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.

🇨🇳

Beijing, China

Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University

🇨🇳

Shanghai, China

Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine

🇨🇳

Nanjing, Jiangsu, China

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