GJS: Real herbal extract granule/Duolac7S: Real probiotics

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

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

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

Irritable Bowel Syndrome

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)

Herbal extract granule and 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).

Herbal extract granule and 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).
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)

Placebo herbal extract granule and 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).

Placebo herbal extract granule and placebo probiotics

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

Kyung Hee University Hospital at Gangdong

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

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.

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

The patients should write diaries of stool's frequency, consistency and ease of passage
Frequency (number of defecation in a day)
Consistency (judged by Bristol scale)
Ease of passage

Abdominal pain, abdominal discomfort, bloating, flatulence, urgency, mucus in stool and overall symptom would be evaluated through visual analog scale (100mm)

To investigate the changes of intestinal microbes before and after experiment, feces should be collected.
The feces will be analyzed by the method of DGGE (denaturing gradient gel electrophoresis - PCR of DNA).

In order to evaluate intesinal permeability, the urine should be collected after orally administration of lactulose and mannitol.

naringin/vomissement

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

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