Functional Dyspepsia Clinical Trial
Official title:
A Multi-center, Randomized, Double-Blind, Placebo-Controlled Parallel Group Clinical Trial of Zhizhu Kuanzhong Capsule in Treating Patients With Postprandial Distress Syndrome of Functional Dyspepsia
This trial aims to evaluate the clinical efficacy and safety of Zhizhu Kuanzhong Capsule in the treating patients with functional dyspepsia postprandial distress syndrome(FD PDS). Half of participants will receive Zhizhu Kuanzhong Capsule,while the other will receive a placebo.
Status | Recruiting |
Enrollment | 480 |
Est. completion date | December 2023 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Meeting the Rome IV diagnostic criteria for functional dyspepsia-postprandial distress syndrome; 2. * At least 3 days during the one-week run-in period with VAS score = 4 for major symptoms (at least one of postprandial fullness discomfort and early satiety) . 3. Age between 18 and 65 years old (including 18 and 65 years old), male or female, outpatients; 4. **Be able to discontinue prohibited medications that may affect the evaluation of the effectiveness, such as acid inhibition/antacids, prokinetic agents, non-steroidal anti-inflammatory drugs, anticholinergic agents, glucocorticoids, and therapeutic medication for H. pylori eradication. 5. Each subject is informed and voluntarily signed the informed consent form(ICF). - Subjects who entered the one-week run-in period are self-rated on the Visual Analogue Score (VAS) for the degree of discomfort with both symptoms of postprandial fullness and early fullness, with subjects indicating the degree of discomfort on a 10 cm ruler marked 0- "Asymptomatic or No Discomfort"and 10- "Extreme Severe or Extreme Discomfort"at its head and tail, respectively. The rating was made once a day and 7 days a week with scores of 0 to 10. - A 2-week wash-out period is required for patients taking prohibited medications prior to screening. Exclusion Criteria: 1. Gastroscopic findings of gastric cancer, peptic ulcer, erosive gastritis (grade 2 or higher), moderate to severe atrophic gastritis, dysplasia, or other organ gastrointestinal disease. 2. Patients with a history of abdominal surgery (except for appendectomy and cesarean section). 3. Patients with immune system defects (such as leukaemia or cancer), or those who have been administered immunosuppressive agents or glucocorticoids within the past 3 months. 4. Patients who combined severe cardiac and pulmonary insufficiency, insufficiency of liver (ALT/AST > 1.5 times the upper limit of the normal value) and kidney insufficiency (BUN/Serum Creatinine > the upper limit of the normal value), abnormal of endocrine system( such as diabetes and thyroid dysfunction), abnormal hematopoietic system, and iron deficiency anemia as indicated on hematological examination. 5. Patients with severe anxiety and depression. 6. Patients with psychosis and mental retardation as well as language disorder precluding the ability of filling scales or recording symptoms. 7. Pregnant (a female of childbearing potential with a positive pregnancy test) or lactating females; or patients of childbearing potential without effective contraception. 8. Patients who are known to be allergic to the ingredients of this drug. 9. Patients who are suspected to have or indeed have a history of alcohol or drug abuse. 10. Patients who have participated in a clinical trial in the past 3 months. 11. Patients who are deemed by the investigator as being not suitable for participation in the clinical trial. |
Country | Name | City | State |
---|---|---|---|
Australia | Princess Alexandra Hospital | Brisbane | Queensland |
China | Beijing Jishuitan Hospital | Beijing | Beijing |
China | Peking Union Medical College Hospital of Chinese Academy of Medical Sciences | Beijing | Beijing |
China | Xiyuan Hospital of China Academy of Chinese Medical Sciences | Beijing | Beijing |
China | Fujian Provincial Hospital | Fuzhou | Fujian |
China | Peking Union Medical College Hospital of Chinese Academy of Medical Sciences | Guangzhou | Guangdong |
China | The First Affiliated Hospital of Guangzhou University of Chinese Medicine | Guangzhou | Guangdong |
China | Hong Kong Baptist University | Hong Kong | Hongokng |
China | Jiangsu Province Hospital | Nanjing | Jiangsu |
China | Ruijin Hospital | Shanghai | Shanghai |
China | Shengjing Hospital Affiliated to China Medical University | Shenyang | Liaoning |
China | Kulun Qimeng Hospital | Tongliao | Neimenggu |
China | Wuhan Union Hospital | Wuhan | Hubei |
China | Affiliated Hospital of Shaanxi University of traditional Chinese medicine | Xi'an | Shanxi |
China | Shaanxi Academy of Traditional Chinese Medicine | Xi'an | Shanxi |
China | The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shanxi |
Lead Sponsor | Collaborator |
---|---|
Xiyuan Hospital of China Academy of Chinese Medical Sciences |
Australia, China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The proportion of the response at 8 weeks after randomization | Subjects with the functional dyspepsia-postprandial distress syndrome are self-rated on the Visual Analogue Score (VAS) which is a scale of 0-10, with subjects indicating the degree of discomfort on a 10 cm ruler marked 0- "Asymptomatic or No Discomfort "to 10- "Extreme Severe or Extreme Discomfort "at its head and tail, respectively. The record is made once a day and 7 days a week via a diary card. For VAS scores for postprandial fullness discomfort and early satiety, the integral average for both symptoms over the past week is evaluated, and a 50% decrease from baseline in the integral average at 8 Weeks is recorded as a response. | up to 8 weeks | |
Secondary | The change of VAS score of each symptom of functional dyspepsia | On the diary cards, subjects recorded the Visual Analogue Score (VAS) of each symptom of the functional dyspepsia daily. VAS is scored on a scale of 0-10 which the higher the score, the severer the symptom is. The record is made once a day and 7 days. The investigators use the average of the weekly VAS scores as the symptom intensity score for this week, with one VAS score per week. The change in the score of each symptom at 8 weeks after randomization relative to the baseline is evaluated. | Up to 8 weeks | |
Secondary | Overall treatment response rate | The overall treatment efficacy is evaluated using a 7-point Likert Overall Evaluation Scale (OTE). The clinical investigators asked the subjects the following questions weekly: "In the last week, how much have your dyspeptic symptoms been alleviated as compared to pre-treatment? " There are 7 options: ? the symptoms improved significantly, ? the symptoms improved, ? the symptoms improved slightly, ? the symptoms did not change, ? the symptoms aggravated slightly, ? the symptoms aggravated, ? the symptoms aggravated significantly. At the last visit time point of the treatment cycle, patients who selected ? and ? were defined as treatment responders, and those who selected ?-? were defined as non-responders. The response rate at 8 weeks after randomization between the groups are compared for differences. | Up to 8 weeks | |
Secondary | Short Form Nepean Dyspepsia Index (SFNDI) | Short Form-Nepean Dyspepsia Index (SFNDI) is a reliable and valid measure of quality of life in functional dyspepsia with 10 items which questions are about how subjects stomach pain, discomfort, or other epigastric symptoms over the last 14 days affect their lives. Add up the ten items for each of the five sub-scale scores (range of each sub-scale 2-10). The changes of SFNDI score at 4 weeks and 8 weeks after randomization relative to the baseline are calculated. | Up to 8 weeks | |
Secondary | Hospital Anxiety and Depression Scale score | The Hospital Anxiety and Depression Scale (HAD) is mainly used in patients in general hospitals which provides two sets of tests to assess the state of anxiety and depression, respectively. Among them, A stands for anxiety items, D stands for depression items, and each item is scored at four levels. Each of the two sets of items are superimposed to obtain their respective total score. A total score of 0 to 7 indicates normal, 8 to 10 indicates borderline abnormal, and 11 to 21 indicates abnormal. The changes of HAD score at 4 weeks and 8 weeks after randomization relative to the baseline are calculated. | Up to 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04656730 -
Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas
|
Phase 4 | |
Completed |
NCT04464369 -
Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial
|
Phase 4 | |
Completed |
NCT01671670 -
Acupuncture for Patients With Function Dyspepsia
|
Phase 2/Phase 3 | |
Completed |
NCT00987805 -
Efficacy of Banhasasim-tang on Functional Dyspepsia
|
Phase 4 | |
Completed |
NCT00761358 -
To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia
|
Phase 3 | |
Completed |
NCT00693407 -
Study of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation
|
N/A | |
Recruiting |
NCT01240096 -
Mirtazapine Versus Placebo in Functional Dyspepsia
|
Phase 4 | |
Recruiting |
NCT04540549 -
Effects of Exercise on Functional Dyspepsia Based on Rome IV
|
N/A | |
Recruiting |
NCT03652571 -
Nortriptyline for the Treatment of Functional Dyspepsia
|
Phase 3 | |
Recruiting |
NCT06068114 -
Gastric Pathophysiology in Diabetes
|
||
Not yet recruiting |
NCT04548011 -
Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia
|
N/A | |
Terminated |
NCT02567578 -
A Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia
|
Phase 2 | |
Completed |
NCT03007433 -
Assessment of GI Function to a Large Test Meal by Non-invasive Imaging
|
N/A | |
Active, not recruiting |
NCT00990405 -
Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia
|
Phase 4 | |
Completed |
NCT00404534 -
Helicobacter Eradication Relief of Dyspeptic Symptoms
|
Phase 3 | |
Completed |
NCT03043625 -
Visceral Manipulation Treatment to Patients With Non-specific Neck Pain With Functional Dyspepsia
|
N/A | |
Completed |
NCT03225248 -
Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia
|
Phase 3 | |
Recruiting |
NCT05587127 -
Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia
|
N/A | |
Recruiting |
NCT01021475 -
Does Visceral Manipulation Works in Treating Functional Dyspepsia?
|
Phase 1 | |
Completed |
NCT00599677 -
Randomized Controlled Trial of Acupuncture for Functional Dyspepsia
|
N/A |