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This clinical trial was designed to evaluate the functional and safety effects on dyspeptic symptoms compared to the placebo when ingested with EDL (Extract of Dolichos lablab Linne) in adults who complain of dyspeptic symptoms.
Dyspepsia is a common disease and accounts for about 5% of all patients visiting primary care. Of these, about 70~90% of dyspeptic patients who visit the tertiary medical institution have functional digestion, considering that about 8~20% of dyspeptic patients who are referred from the primary medical institution to the tertiary medical institution are found. It is estimated to be bad. Functional dyspepsia is not life-threatening, but its symptoms persist throughout life and are not easily cured, which can limit social life and reduce the quality of life.
Therefore, this clinical trial was designed to evaluate the functional and safety effects on dyspeptic symptoms compared to the placebo when ingested with EDL (Extract of Dolichos lablab Linne) in adults who complain of dyspeptic symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDL(Extract of Dolichos lablab Linne) | Experimental | The randomly assigned target was given a Extract of Dolichos lablab Linne (EDL) 715 mg/day for 12 weeks. |
|
| Placebo comparator | Placebo Comparator | The randomly assigned target was given a placebo for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extract of Dolichos lablab Linne (EDL) | Dietary Supplement | Investigational product (EDL): once a day, 2 tablets orally intake (Extract of Dolichos lablab Linne 715 mg/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| GSRS(Gastrointestinal Symptom Rating Scale) Stomach symptom score | GSRS (Gastrointestinal Symptom Rating Scale) Stomach symptom score change after 12 weeks of administration, compared to Baseline.
| 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| GSRS(Gastrointestinal Symptom Rating Scale) Stomach symptom score | GSRS (Gastrointestinal Symptom Rating Scale) Stomach symptom score change after 6 weeks of administration, compared to Baseline.
| 6 weeks |
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Inclusion Criteria:
Those over the age of 19
Those diagnosed with functional dyspepsia (Rome IV*)
* One or more of the following symptoms are diagnosed when there is no organic cause in the test including the upper gastrointestinal endoscopy(if symptoms begin 6 months prior to Visit 1, and the symptoms are present in the past 3 months).
A person who has 4 or more of the 10 symptoms in the GIS (Gastrointestinal Symptom) questionnaire and has a total score of 12 or more (5-point Likert scale)
When there is no organic disease in the gastroscopy performed at Visit 1 (however, it can be replaced by the test results within 3 months from Visit 1)
A person who consented to participate in this clinical trial and signed a Informed consent form before the trail began.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nayoung Kim, M.D., Ph. D. | Contact | 82-31-787-7008 | nayoung49@empas.com |
| Name | Affiliation | Role |
|---|---|---|
| Nayoung Kim, M.D., Ph. D. | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
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Subjects are randomly assigned to either the test group or the control group according to the registered order. Subjects take investigational product or placebo for 12 weeks.
Investigational product (EDL): once a day, 2 tablets orally intake (Extract of Dolichos lablab Linne 715 mg/day) Placebo: consumed in the same way as the investigational product
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| Placebo oral tablet | Other | Placebo: consumed in the same way as the investigational product |
|
| GSRS(Gastrointestinal Symptom Rating Scale) Total score | GSRS (Gastrointestinal Symptom Rating Scale) Total score change after 6 weeks, 12 weeks of administration, compared to Baseline.
| 6 weeks, 12 weeks |
| GIS(Gastrointestinal Symptom) | GIS(Gastrointestinal Symptom) score change after 6 weeks, 12 weeks of administration, compared to Baseline.
| 6 weeks, 12 weeks |
| FD-QoL(Functional Dyspepsia-Related Quality of Life) | FD-QoL(Functional Dyspepsia-Related Quality of Life) score change after 12 weeks of administration, compared to Baseline.
| 12 weeks |
| ESR(Erythrocyte Sedimentation Rate) | ESR(Erythrocyte Sedimentation Rate) change after 6 weeks, 12 weeks of administration, compared to Baseline. | 6 weeks, 12 weeks |
| CRP(C-Reactive Protein) | CRP(C-Reactive Protein) change after 6 weeks, 12 weeks of administration, compared to Baseline. | 6 weeks, 12 weeks |
| IFN-γ(Interferon) | IFN-γ(Interferon) change after 12 weeks of administration, compared to Baseline. | 12 weeks |
| TNF-α(Tumor necrosis factors) | TNF-α(Tumor necrosis factors) change after 12 weeks of administration, compared to Baseline. | 12 weeks |
| 8-OhdG(8-Oxo-2'-deoxyguanosine) | 8-OhdG(8-Oxo-2'-deoxyguanosine) change after 12 weeks of administration, compared to Baseline. | 12 weeks |
| TAS(total antioxidnat status) | TAS(total antioxidnat status) change after 12 weeks of administration, compared to Baseline. | 12 weeks |