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Trial record 13 of 40 for:    Citrus reticulata

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

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ClinicalTrials.gov Identifier: NCT02330029
Recruitment Status : Unknown
Verified November 2016 by Macrohard Institute of Health.
Recruitment status was:  Active, not recruiting
First Posted : January 1, 2015
Last Update Posted : November 22, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome
Study Start Date : August 2012
Actual Primary Completion Date : November 2014
Estimated Study Completion Date : May 2017

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 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.




Primary Outcome Measures :
  1. Abdominal pain [ Time Frame: 2 years ]
    0 = no pain, 10 worst pain

  2. Primary endpoint --- vi) Form (appearance) of stool [ Time Frame: 2 years ]
    Use Bristol stool scale.


Secondary Outcome Measures :
  1. Frequency of the pain [ Time Frame: 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.

  2. # of stools per day [ Time Frame: 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.

  3. Abdominal discomfort [ Time Frame: 2 years ]
    0 = no discomfort...... 10 = Worst possible, unbearable unbearable discomfort

  4. Frequency of discomfort [ Time Frame: 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:
  1. IBS global symptom relief [ Time Frame: 2 years ]
    IBS global symptom relief was evaluated by each patient at the end of the therapy as "improved", "stayed the same", or "worsened"

  2. Treatment-emergent adverse effect (TEAE) profiles. [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330029


Locations
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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
Macrohard Institute of Health
Investigators
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Principal Investigator: Baiwen Li, MD Department of Gastroenterology, Shanghai First People's Hospital, Shanghai Jiao Tong University, 100 Haining Rd. Hongkou, Shanghai 200280, China.

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Responsible Party: Macrohard Institute of Health
ClinicalTrials.gov Identifier: NCT02330029     History of Changes
Other Study ID Numbers: D00320141210
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: November 22, 2016
Last Verified: November 2016

Keywords provided by Macrohard Institute of Health:
Irritable bowel syndrome,
Pinaverium
Herbal medication for IBS,
Tong Xie Yao Fang (Formula for pain and diarrhea)

Additional relevant MeSH terms:
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Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pinaverium
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents