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

Irritable Bowel Syndrome Clinical Trial

Official title:

A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02330029
• Other study ID #: D00320141210
• Status: Active, not recruiting
• Phase: N/A
• First received: December 29, 2014
• Last updated: November 18, 2016
• Start date: August 2012
• Est. completion date: May 2017

Study information

• Verified date: November 2016
• Source: Macrohard Institute of Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardChina: Food and Drug Administration
• Study type: Interventional

Clinical 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). 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: May 2017
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

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.

Device:
• Atractylodes
Atractylodes (~10-15g)
• Paeonia Lactiflora
Paeonia Lactiflora (~15-30g)
• Tangerine Peel
Tangerine Peel (~10g)

Drug:
• Ledebouriella Root
Ledebouriella Root (~10g)
• Radix codonopsitis
Radix codonopsitis (~10-15g)
• Radix curcumae
Radix curcumae (~10g)
• Fingered citron
Fingered citron (~10g)
• Tuckahoe
Tuckahoe (15g)
• Placebo
Placebo is blindly given to patients.

Locations

Country	Name	City	State
China	Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.	Beijing
China	Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine	Nanjing	Jiangsu
China	Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine	Nanjing	Jiangsu
China	Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Macrohard Institute of Health

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	IBS global symptom relief	IBS global symptom relief was evaluated by each patient at the end of the therapy as "improved", "stayed the same", or "worsened"	2 years	No
Other	Treatment-emergent adverse effect (TEAE) profiles.		2 years	No
Primary	Abdominal pain	0 = no pain, 10 worst pain	2 years	No
Primary	Primary endpoint --- vi) Form (appearance) of stool	Use Bristol stool scale.	2 years	No
Secondary	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.	2 year	No
Secondary	# 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.	2 years	No
Secondary	Abdominal discomfort	0 = no discomfort...... 10 = Worst possible, unbearable unbearable discomfort	2 years	No
Secondary	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.	2 years	No