Clinical trial NCT02330029: Pinaverium and Herbs for Irritable Bowel Syndrome Treatment: an Onset and Offset Study (PHIBEST)
Official title: A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome,
Pinaverium
Herbal medication for IBS,
Tong Xie Yao Fang (Formula for pain and diarrhea)
Lead sponsor: Macrohard Institute of Health
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Abdominal pain
timeFrame: 2 years
measure: Primary endpoint --- vi) Form (appearance) of stool
timeFrame: 2 years
Secondary outcomes:
measure: Frequency of the pain
timeFrame: 2 year
measure: # of stools per day
timeFrame: 2 years
measure: Abdominal discomfort
timeFrame: 2 years
measure: Frequency of discomfort
timeFrame: 2 years
Other outcomes:
measure: IBS global symptom relief
timeFrame: 2 years
measure: Treatment-emergent adverse effect (TEAE) profiles.
timeFrame: 2 years
Locations:
city: Nanjing
country: China
facility: Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
state: Jiangsu
city: Beijing
country: China
facility: Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.
city: Shanghai
country: China
facility: Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University
Study officials:
affiliation: Department of Gastroenterology, Shanghai First People's Hospital, Shanghai Jiao Tong University, 100 Haining Rd. Hongkou, Shanghai 200280, China.
name: Baiwen Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zheng L, Lu W, Xiao Q, Lai Y, Fan H, Sun Y, Huang D, Wang Y, Li Z, Jiang Z, Liu X, Zhang L, Zuo D, Shou Z, Tang Q, Huang H, Yang Y, Tang Z, Xiao J. Assessing the post-treatment therapeutic effect of pinaverium in irritable bowel syndrome: a randomized controlled trial. Sci Rep. 2021 Jul 6;11(1):13894. doi: 10.1038/s41598-021-92990-7.