Actively Recruiting
A Study of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome
Led by Tasly Pharmaceutical Group Co., Ltd · Updated on 2026-01-20
342
Participants Needed
18
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. Based on the Response rate of postprandial distress syndrome participants, evaluate whether the efficacy of Lianxiaxiaopi Granules is superior to placebo. 2. Evaluate the efficacy of Lianxiaxiaopi Granules in improving symptom of postprandial distress syndrome. 3. Evaluating the safety of Lianxiaxiaopi Granules in postprandial distress syndrome participants.
CONDITIONS
Official Title
A Study of Lianxiaxiaopi Granules in the Treatment of Postprandial Distress Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years old (including boundary values), any gender
- Diagnosis meeting Rome IV criteria for postprandial distress syndrome
- Traditional Chinese Medicine diagnosis of cold and heat miscellaneous syndromes
- Symptom severity score (NRS) of at least 4 for one postprandial distress symptom at screening and baseline
- No moderate or severe epigastric pain syndrome with scores below 4
- No significant organic abnormalities found by gastroscopy or only mild gastritis/erythema grade I or erosion grade I
- Negative Helicobacter pylori breath test during screening
- Voluntary participation with informed consent and understanding of study procedures
You will not qualify if you...
- Helicobacter pylori eradication treatment within 6 months before screening
- Gastric mucosal erythema grade II or above, bulging or grade II erosion, bleeding, bile reflux, or 3 or more inflammatory polyps
- Diagnosed digestive diseases causing dyspepsia such as tumors, hepatobiliary or pancreatic diseases, inflammatory bowel disease
- Other illnesses affecting dyspepsia evaluation including reflux esophagitis, peptic ulcer, gastrointestinal bleeding, intestinal obstruction
- Serious systemic diseases affecting digestive function such as hyperthyroidism, hypothyroidism, diabetes, chronic kidney failure, connective tissue diseases
- Severe cardiovascular, liver, lung, kidney, blood, or mental illnesses such as moderate/severe depression, anxiety, or bipolar disorder
- History of major abdominal surgery affecting digestion, except appendectomy, cesarean section, or specific minor surgeries
- Abnormal liver function (ALT or AST >1.5x normal) or abnormal kidney function
- High blood sugar or glycosylated hemoglobin (HbA1c ≥ 6.5%, fasting glucose ≥ 7 mmol/L) during screening
- Use of drugs or treatments impacting study evaluation within 2 weeks before screening
- Pregnant or breastfeeding women, or planning pregnancy within one month after enrollment and trial end
- History or suspicion of alcohol or drug abuse
- Participation in other clinical trials within 1 month before screening
- Known or suspected allergy to study medicine ingredients
- Investigator judgment deeming participation unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
Not Yet Recruiting
2
Gansu Provincial Hospital of Traditional Chinese Medicine
Lanzhou, Gansu, China
Not Yet Recruiting
3
The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Guiyang, Guizhou, China
Not Yet Recruiting
4
Hebei Provincial Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China
Not Yet Recruiting
5
The Second Affiliated Hospital of Xingtai Medical College
Xingtai, Hebei, China
Not Yet Recruiting
6
Baoding No. 1 Hospital of Traditional Chinese Medicine
Baoding, Heibei, China
Not Yet Recruiting
7
The First People's Hospital of Luoyang City
Luoyang, Henan, China
Actively Recruiting
8
The Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, China
Not Yet Recruiting
9
General Hospital of the Northern Theater of the Chinese People's Liberation Army
Shenyang, Liaoning, China
Not Yet Recruiting
10
The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Shenyang, Liaoning, China
Not Yet Recruiting
11
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
12
The Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine
Xianyang, Shanxi, China
Not Yet Recruiting
13
The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China
Actively Recruiting
14
West China Hospital Sichuan University
Chengdu, Sichuan, China
Not Yet Recruiting
15
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China
Not Yet Recruiting
16
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, China
Not Yet Recruiting
17
Zhejiang Provincial Hospital of Traditional Chinese Medicine
Hangzhou, Zhejiang, China
Not Yet Recruiting
18
Wenzhou Hospital of Traditional Chinese Medicine
Wenzhou, Zhejiang, China
Not Yet Recruiting
Research Team
P
Peimin Feng, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here