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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01641224
First received: May 23, 2012
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to test the efficacy and safety of pinaverium and an herbal medication for irritable bowel syndrome (IBS). 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 when tested by modern clinical standards and criteria.


Condition Intervention
Irritable Bowel Syndrome
Drug: Pinaverium
Device: Atractylodes
Device: Paeonia Lactiflora
Device: Tangerine Peel
Drug: Ledebouriella Root
Drug: Radix codonopsitis
Drug: Radix curcumae
Drug: Fingered citron
Drug: Tuckahoe
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • The relief of irritable bowel syndrome symptoms was used to measure the effectiveness of the drugs [ Time Frame: TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks. ] [ Designated as safety issue: No ]
    The parameters used to evaluate the effectiveness of the drugs included i) Abdominal pain (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain); ii) Frequency of the pain (# of pains per day); iii) Abdominal discomfort (0 = No discomfort,1 = mild,2 = moderate,3 = severe); iv) Frequency of discomfort (# of discomfort per day); v) # of stools per day; vi) Form (appearance) of stool (0 = Normal,1 = soft pieces with clear-cut edges,2 = mushy,3 = watery)


Secondary Outcome Measures:
  • The side effect associated with the treatments [ Time Frame: TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks. ] [ Designated as safety issue: No ]
    The following will be documented: constipation, headache, dizzy, hypertension, chest pain, abdominal pain, flatus, anxiety, insomnia, nausea, fever, fatigue, muscle pain, urinary infection, respiratory tract infection, Others.


Estimated Enrollment: 800
Study Start Date: May 2012
Estimated Study Completion Date: May 2014
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: One of active ingredients in TCM group
Device: Paeonia Lactiflora
Paeonia Lactiflora (~15-30g)
Other Name: One of active ingredients in TCM group
Device: Tangerine Peel
Tangerine Peel (~10g)
Other Name: One of active ingredients in TCM group
Drug: Ledebouriella Root
Ledebouriella Root (~10g)
Other Name: One of active ingredients in TCM group
Drug: Radix codonopsitis
Radix codonopsitis (~10-15g)
Other Name: One of active ingredients in TCM group
Drug: Radix curcumae
Radix curcumae (~10g)
Other Name: One of active ingredients in TCM group
Drug: Fingered citron
Fingered citron (~10g)
Other Name: One of active ingredients in TCM group
Drug: Tuckahoe
Tuckahoe (15g)
Other Name: One of active ingredients in TCM group
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.
Placebo Comparator: Placebo
Placebo is blindly given to patients
Drug: Placebo
Placebo is blindly given to patients.

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.

This study is designed to evaluate the efficacy and safety 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01641224

Locations
China, Jiangsu
Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
Nanjing, Jiangsu, China, 210017
Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
Nanjing, Jiangsu, China, 210029
China
Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.
Beijing, China, 100050
Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University
Shanghai, China, 200240
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Jun Xiao, Ph.D. University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01641224     History of Changes
Other Study ID Numbers: 1106E00524
Study First Received: May 23, 2012
Last Updated: May 9, 2014
Health Authority: United States: Institutional Review Board
China: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Irritable bowel syndrome,
Pinaverium
Herbal medication for IBS,
Tong Xie Yao Fang (Formula for pain and diarrhea)

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pinaverium
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 26, 2014