- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01342718
Effect of Herbal Extract Granules Combined With Probiotics on Irritable Bowel Syndrome With Diarrhea
Study Overview
Status
Conditions
Detailed Description
Irritable bowel syndrome (IBS), a common chronic gastrointestinal disorder characterized by abdominal pain and alteration of bowel habits in the absence of structural abnormality, has a prevalence of approximately 15% in western populations1,2. Patients with IBS can be classified by their predominant bowel habits: diarrhea-predominant IBS (D-IBS), constipation-predominant IBS, or IBS with alternating bowel movements3. Although smooth-muscle relaxants, bulking agents, and anti-diarrheal agents are commonly used as conventional IBS treatments, many IBS patients turn to alternative treatments because of the lack of therapeutic advantages of these treatments4. Therefore, the development of a new therapy is necessary for IBS patients.
Gwakhyangjeonggisan (GJS; Kkako-shoki-san in Kampo Medicine; Huoxiang-zhengqi-san in Traditional Chinese Medicine), which was recorded originally in the famous ancient herbal formula literature "Formularies of the Bureau of people's Welfare Pharmacies", consists of 13 common crude herbs. GJS contains the chemical ingredients naringin, hesperidin, thymol, honokiol and magnolol5. GJS has been shown to protect intestinal barrier function6, contract the colonic muscle7, and regulate infectious diarrhea8 in vivo. In traditional Korean medicine, this herbal formula has long been used for relieving abdominal pain, diarrhea, and vomiting as an over-the-counter or prescribed medicine9-11. However, there have been no clinical trials to investigate the efficacy of GJS in IBS.
Probiotics are defined as viable microorganisms, which confer potential health benefits on the host when taken in proper amounts12. They are easily available, do not require a prescription, and are administered extensively for the relief of abdominal symptoms13. According to a recent systematic review and meta-analysis study, probiotics caused a modest improvement in the overall IBS symptoms14. The rationale for using probiotics for IBS is based on the assumption that they modify the composition of the intestinal microflora15 and regulate intestinal permeability by modulating the epithelial tight junctions16. Duolac7S (DUO), a probiotic mixture, contains 7 bacterial species including Bifidobacterium, Lactobacillus, and Streptococcus. Each of these bacterial species is reportedly beneficial for IBS17. DUO has been approved by the Korean Food and Drug Administration for restoring the ecological balance of intestinal microflora and improving intestinal symptoms18. Although DUO has been widely used as an over-the-counter product for IBS-related symptoms, no clinical trials have investigated the efficacy of DUO on IBS.
Recently, several herbal formulas and probiotics have been simultaneously administered to IBS patients for relieving abdominal symptoms19. In addition to lack of clinical evidence for the use of GJS or DUO, the efficacy of their combined treatment for IBS has not been elucidated. Thus, there is a need to evaluate the safety and efficacy of administration of GJS, DUO, or a combination therapy as a frequently used treatment for IBS. In the current trial, we identified the safety and efficacy of GJS, DUO, or a combination therapy on D-IBS by evaluating IBS symptoms and quality of life. To investigate their mechanisms in humans, intestinal permeability and composition of intestinal microbiota were assessed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Gangdong-gu
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Seoul, Gangdong-gu, Korea, Republic of, 130-701
- Kyung Hee University Hospital at Gangdong
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age of 18 - 75, with a elementary-school diploma or higher, must be literate
- One who meet Rome Ⅲ IBS-D criteria
- One who agree on not taking other therapies during experimental period
- During the past 5 yrs, no history of organic lesion proven by colonoscopy
- One who agree on consent form
Exclusion Criteria:
- Patients who have abdominal operation in the past(exception: appendectomy, caesarean section, tubal ligation, laparoscopic cholecystectomy, hysterectomy and abdominal wall hernia repair)
- No history of non-functional bowel disease(cholangitis, pancreatitis, enteritis, ulcer, bleeding, cancer, etc.)
- Before participation clinical trial, one who took over-the-count medication affecting GI motility
- One who takes antibiotics during run-in period (2 wks)
- One who takes probiotics within 2 wks before experiment
- Pregnant woman
- One who disagree on the consent form
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: GJS/Duolac7S
GJS: Real herbal extract granule/Duolac7S: Real probiotics
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The herbal extract granule, Gwakhyangjeonggisan granule, consists of 11 herbs. Ingredients: Agastachis, Perillae Folium, Angelicae Radix, Arecae Pericarpium, Hoelen, Magnoliae officinalis Cortex, Atractylis Rhizoma, Aurantii nobilis Percarpium, Pinelliae Rhizoma, Platycodi Radix, Glychrrhizae Radix. Dosage and frequency: 1 pack (3g), 3 packs per day (2 hours after morning, afternoon and evening meal) The probiotics, Duolac7S, consist of 7 bacteria. Ingredients: Lactobacillus acidophilus, L. plantarum, L. rhamnosus, Bifidobacterium breve, B. lactis, B. longum, Streptococcus thermophilus. Dosage and frequency: 1 capsule (5✕1,000,000,000 bacteria/capsule [7✕100,000,000 viable cells/strain]), 2 capsules per day (2 hours after morning and evening meal)
Other Names:
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PLACEBO_COMPARATOR: GJS-P/Duolac7S
GJS-P: Placebo herbal extract granule/Duolac7S: Real probiotics
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The Gwakhyangjeonggisan placebo has the same form, color and flavor as experimental intervention (Gwakhyangjeonggisan). The dosage, frequency and duration is also the same as experimental intervention (Gwakhyangjeonggisan). The probiotics, Duolac7S, consist of 7 bacteria. Ingredients: Lactobacillus acidophilus, L. plantarum, L. rhamnosus, Bifidobacterium breve, B. lactis, B. longum, Streptococcus thermophilus. Dosage and frequency: 1 capsule (5✕1,000,000,000 bacteria/capsule [7✕100,000,000 viable cells/strain]), 2 capsules per day (2 hours after morning and evening meal)
Other Names:
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PLACEBO_COMPARATOR: GJS/Duolac7S-P
GJS: Real herbal extract granule/Duolac7S-P: Placebo probiotics
|
The herbal extract granule, Gwakhyangjeonggisan granule, consists of 11 herbs. Ingredients: Agastachis, Perillae Folium, Angelicae Radix, Arecae Pericarpium, Hoelen, Magnoliae officinalis Cortex, Atractylis Rhizoma, Aurantii nobilis Percarpium, Pinelliae Rhizoma, Platycodi Radix, Glychrrhizae Radix. Dosage and frequency: 1 pack (3g), 3 packs per day (2 hours after morning, afternoon and evening meal). Duolac7S placebo has the same form, color and flavor as experimental intervention (Duolac7S). The dosage, frequency and duration is also the same as experimental intervention (Duolac7S).
Other Names:
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PLACEBO_COMPARATOR: GJS-P/Duolac7S-P
GJS-P: Placebo herbal extract granule/Duolac7S-P: Placebo probiotics
|
The Gwakhyangjeonggisan placebo has the same form, color and flavor as experimental intervention (Gwakhyangjeonggisan). The dosage, frequency and duration is also the same as experimental intervention (Gwakhyangjeonggisan). Duolac7S placebo has the same form, color and flavor as experimental intervention (Duolac7S). The dosage, frequency and duration is also the same as experimental intervention (Duolac7S).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adequate relief (AR) of IBS pain & discomfort
Time Frame: Weekly (during run-period [2 wks], administarion period [8 wks] and follow-up period [2 wks])
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As the participants answer the question "in the past seven days have you had adequate relief of your irritable bowel syndrome pain and discomfort?" in the form of "Yes" or "No", the effect can be assessed.
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Weekly (during run-period [2 wks], administarion period [8 wks] and follow-up period [2 wks])
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Proportion of responders
Time Frame: Once in each period (run-period [2 wks], administarion period [8 wks] and follow-up period [2 wks])
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The proportion of responders who answer "Yes" to more than half of AR questions in each period (>50%)
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Once in each period (run-period [2 wks], administarion period [8 wks] and follow-up period [2 wks])
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Daily assessment of bowel function scores
Time Frame: Daily (during run-period [2 wks], administarion period [8 wks] and follow-up period [2 wks])
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Daily (during run-period [2 wks], administarion period [8 wks] and follow-up period [2 wks])
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Daily assessment of severity of individual symptoms related to defecation
Time Frame: Daily (during run-period [2 wks], administarion period [8 wks] and follow-up period [2 wks])
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Abdominal pain, abdominal discomfort, bloating, flatulence, urgency, mucus in stool and overall symptom would be evaluated through visual analog scale (100mm)
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Daily (during run-period [2 wks], administarion period [8 wks] and follow-up period [2 wks])
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Changes on population of intestinal microbes
Time Frame: Two times in administration period (0 and 8 wks)
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Two times in administration period (0 and 8 wks)
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Intestinal permeability test
Time Frame: Two times in administration period (0 and 8 wks)
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In order to evaluate intesinal permeability, the urine should be collected after orally administration of lactulose and mannitol.
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Two times in administration period (0 and 8 wks)
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Collaborators and Investigators
Investigators
- Principal Investigator: Jae-Woo Park, KMD, PhD, Department of Internal Medicine, College of Oriental Medicine, Kyung Hee University, 1 Hoegi-dong, Dongdaemun-gu, Seoul 130-701, Republic of Korea
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KHNMC-OH-IRB 2010-011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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