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New treatment option for Postprandial Distress Syndrome
Official title A Study of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome
ClinicalTrials.gov ID: NCT06696261
What this study is testing
What is Lianxiaxiaopi Granules?
Lianxiaxiaopi Granules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for postprandial distress syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is evaluating the efficacy and safety of Lianxiaxiaopi Granules in participant population. The main questions it aims to answer are: 1.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Age 18 to 65 years old (including boundary value), gender is not limited;
- meet the diagnostic criteria for postprandial distress syndrome (Rome IV.);
- Meet the syndrome differentiation standards of Traditional Chinese Medicine for cold and heat miscellaneous syndromes;
- NRS score of at least one symptom of postprandial distress syndrome (postprandial fullness, discomfort, early satiety) in the screening period and...
- Those who did not have organic abnormal changes in the results of gastroscopy (including no abnormalities in gastroscopy, chronic non-atrophic...
You likely can't join if
- Those who have undergone Helicobacter pylori eradication treatment within 6 months before screening;
- Gastric mucosal erythema grade II or above, erosion is bulge or grade II or above, or accompanied by bleeding, bile reflux, ≥ 3 inflammatory polyps...
- Those who have been diagnosed with systemic diseases that seriously affect the function of the digestive tract, such as hyperthyroidism or...
- Patients with severe cardiovascular and cerebrovascular, liver, lung, kidney, blood or systemic diseases that affect their survival; or patients with...
- Those who have a history of major abdominal surgery in the past, which may affect gastrointestinal function (except for appendectomy, cesarean...
- Patients with abnormal liver function (ALT or AST \>1.5 times the upper limit of normal) or abnormal renal function test (Cr\> upper limit of normal);
See the full eligibility criteria
- Age 18 to 65 years old (including boundary value), gender is not limited;
- meet the diagnostic criteria for postprandial distress syndrome (Rome IV.);
- Meet the syndrome differentiation standards of Traditional Chinese Medicine for cold and heat miscellaneous syndromes;
- NRS score of at least one symptom of postprandial distress syndrome (postprandial fullness, discomfort, early satiety) in the screening period and baseline period≥ 4 points; and did not have moderate/severe epigastric...
- Those who did not have organic abnormal changes in the results of gastroscopy (including no abnormalities in gastroscopy, chronic non-atrophic gastritis/chronic superficial gastritis with erythema grade I and/or erosion...
- Negative Helicobacter pylori test in 13C/14C breath test during the screening period;
- Voluntarily participate in clinical trials, sign informed consent, and understand and comply with research procedures.
- Those who have undergone Helicobacter pylori eradication treatment within 6 months before screening;
- Gastric mucosal erythema grade II or above, erosion is bulge or grade II or above, or accompanied by bleeding, bile reflux, ≥ 3 inflammatory polyps and other manifestations, or combined with pathological diagnosis of...
- Those who have been diagnosed with systemic diseases that seriously affect the function of the digestive tract, such as hyperthyroidism or hypothyroidism, diabetes, chronic renal insufficiency, connective tissue...
- Patients with severe cardiovascular and cerebrovascular, liver, lung, kidney, blood or systemic diseases that affect their survival; or patients with severe mental illness in the past, such as moderate or severe...
- Those who have a history of major abdominal surgery in the past, which may affect gastrointestinal function (except for appendectomy, cesarean section, endoscopic colon polyp resection and other surgeries that do not...
- Patients with abnormal liver function (ALT or AST \>1.5 times the upper limit of normal) or abnormal renal function test (Cr\> upper limit of normal);
- Glycosylated hemoglobin ≥ 6.5% or fasting blood glucose ≥7mmol/L during the screening period;
- Use of drugs or treatments that may have an impact on the how well it works assessment of the trial drug within 2 weeks before screening (such as acid/antacids, gastrointestinal motility drugs, digestive enzymes...
- Pregnant and lactating women, who have a birth plan within one month after enrollment and the end of the trial;
- Those who suspect or have a history of alcohol or drug abuse;
- Participated in other clinical trials within 1 month before screening;
- Those who are suspected or known to be allergic to the ingredients of this medicine;
- According to the judgment of the investigator, it is not suitable to participate in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Lanzhou, Gansu, China
- Guiyang, Guizhou, China
- Shijiazhuang, Hebei, China
- Xingtai, Hebei, China
- Baoding, Heibei, China
- Luoyang, Henan, China
- Changchun, Jilin, China
- Shenyang, Liaoning, China
- Shanghai, Shanghai Municipality, China
- Xianyang, Shanxi, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Kunming, Yunnan, China
- Hangzhou, Zhejiang, China
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Lanzhou, Gansu, China; Guiyang, Guizhou, China; Shijiazhuang, Hebei, China; Xingtai, Hebei, China; Baoding, Heibei, China and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.