Effect of Herbal Extract Granules Combined With Probiotics on Irritable Bowel Syndrome With Diarrhea

NCT01342718 | Completed DMC

• 1 other identifier: KHNMC-OH-IRB 2010-011
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study are to investigate the effect of famous herbal formula extract and probiotics on irritable bowel syndrome with diarrhea, and to determine whether these two experimental items affect intestinal permeability and the composition of intestinal microbiota.

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndrome; Herbal medicine; Probiotics

Outcome Measures

Primary Outcomes (2)

• Adequate relief (AR) of IBS pain & discomfort

  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.

  Weekly (during run-period [2 wks], administarion period [8 wks] and follow-up period [2 wks])

• Proportion of responders

  The proportion of responders who answer "Yes" to more than half of AR questions in each period (\>50%)

  Once in each period (run-period [2 wks], administarion period [8 wks] and follow-up period [2 wks])

Secondary Outcomes (4)

• Daily assessment of bowel function scores

  Daily (during run-period [2 wks], administarion period [8 wks] and follow-up period [2 wks])

• Daily assessment of severity of individual symptoms related to defecation

  Daily (during run-period [2 wks], administarion period [8 wks] and follow-up period [2 wks])

• Changes on population of intestinal microbes

  Two times in administration period (0 and 8 wks)

• Intestinal permeability test

  Two times in administration period (0 and 8 wks)

Study Arms (4)

GJS/Duolac7S

EXPERIMENTAL

GJS: Real herbal extract granule/Duolac7S: Real probiotics

Dietary Supplement: Herbal extract granule and probiotics

GJS-P/Duolac7S

PLACEBO COMPARATOR

GJS-P: Placebo herbal extract granule/Duolac7S: Real probiotics

Dietary Supplement: Placebo herbal extract granule and probiotics

GJS/Duolac7S-P

PLACEBO COMPARATOR

GJS: Real herbal extract granule/Duolac7S-P: Placebo probiotics

Dietary Supplement: Herbal extract granule and placebo probiotics

GJS-P/Duolac7S-P

PLACEBO COMPARATOR

GJS-P: Placebo herbal extract granule/Duolac7S-P: Placebo probiotics

Dietary Supplement: Placebo herbal extract granule and placebo probiotics

Interventions

Herbal extract granule and probiotics DIETARY_SUPPLEMENT

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)

Also known as: Gwakhyangjeonggisan granule and Duolac7S

GJS/Duolac7S

Herbal extract granule and placebo probiotics DIETARY_SUPPLEMENT

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).

Also known as: Gwakhyangjeonggisan granule and placebo Duolac7S

GJS/Duolac7S-P

Placebo herbal extract granule and probiotics DIETARY_SUPPLEMENT

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)

Also known as: Placebo Gwakhyangjeonggisan granule and Duolac7S

GJS-P/Duolac7S

Placebo herbal extract granule and placebo probiotics DIETARY_SUPPLEMENT

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).

Also known as: Placebo Gwakhyangjeonggisan granule and placebo Duolac7S

GJS-P/Duolac7S-P

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kyunghee University Medical Center: lead

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, Gangdong-gu, 130-701, South Korea

Location

Related Publications (1)

• Ko SJ, Ryu B, Kim J, Hong BG, Yeo I, Lee BJ, Lee JM, Park JW. Effect of herbal extract granules combined with probiotic mixture on irritable bowel syndrome with diarrhea: study protocol for a randomized controlled trial. Trials. 2011 Oct 6;12:219. doi: 10.1186/1745-6215-12-219.

  PMID: 21978382 DERIVED

Related Links

• This is the URL of the site in which the clinical trial will be conducted.

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, Department of Internal Medicine

Study Record Dates

• First Submitted: April 25, 2011
• First Posted: April 27, 2011
• Study Start: April 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

KR (1)