An exploratory clinical study on the safety and efficacy of aurantii fructus immaturus flavonoid extract tablets (Aolanti) in the treatment of functional dyspepsia
| ISRCTN | ISRCTN10266781 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10266781 |
- Submission date
- 24/02/2025
- Registration date
- 09/03/2025
- Last edited
- 06/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
This study aimed to evaluate the safety and effectiveness of Aurantii Fructus Immaturus Flavonoid Extract Tablets (Aolanti) in treating functional dyspepsia (FD), a chronic digestive disorder that causes pain and discomfort in the upper abdomen. The goal was to determine the optimal dosage for Phase III clinical trials.
Who can participate?
Patients aged 18 to 65 years with functional dyspepsia
What does the study involve?
Participants were divided into four groups: high-dose, medium-dose, low-dose, and placebo groups. The treatment duration was 28 days, with a follow-up period of 28 days for participants whose symptoms resolved.
What are the possible benefits and risks of participating?
Potential benefits included the alleviation of FD symptoms. Potential risks involved possible adverse drug reactions, although the study results indicated that the drug was well-tolerated with a favorable safety profile.
Where is the study run from?
Jiangxi Qingfeng Pharmaceutical Co., Ltd (China)
When is the study starting and how long is it expected to run for?
June 2011 to December 2012
Who is funding the study?
Jiangxi Qingfeng Pharmaceutical Co., Ltd (China)
Who is the main contact?
Xiaonan Yang, yangxxnan@163.com
Contact information
Public
10th Floor, Block A, Building 2
Shenzhen Bay Science and Technology Ecological Park
Nanshan District
Shenzhen
518063
China
| Phone | +86 (0)18588477550 |
|---|---|
| qitiancheng@qfyy.com.cn |
Scientific
9th Floor, Building 3
Kunsha Center
No. 16 Xinyuanli
Chaoyang District
Beijing
100027
China
| Phone | +86 (0)13811657829 |
|---|---|
| bixiaolei@qfyy.com.cn |
Principal Investigator
West China Hospital of Sichuan University
No. 37, Guoxue Alley
Wuhou District
Chengdu
610041
China
| Phone | +86 (0)13608000318 |
|---|---|
| yangxxnan@163.com |
Study information
| Study design | Stratified block randomized double-blind placebo-parallel-controlled multicenter clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment, Safety, Efficacy |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet” |
| Scientific title | A multicenter, randomized, double-blind, placebo-controlled, dose-exploratory clinical study on the safety and efficacy of aurantii fructus immaturus flavonoid extract tablets (Aolanti) in the treatment of functional dyspepsia |
| Study objectives | A placebo-controlled study to evaluate the efficacy and safety of high, medium, and low doses of Aurantii Fructus Immaturus Flavonoid Extract Tablets (Aolanti) in the treatment of functional dyspepsia, and to explore the optimal dosage for Phase III clinical trials. |
| Ethics approval(s) |
Approved 28/07/2011, Clinical Trial Ethics Committee of West China Hospital of Sichuan University (No. 37 Guoxue Alley, Wuhou District, Chengdu, 610041, China; +86 (0)28 85422114; hxjj@cd120.com), ref: 2008L04094 |
| Health condition(s) or problem(s) studied | Functional dyspepsia |
| Intervention | Patients were divided into one of the experimental groups (high-dose group, medium-dose group, low-dose group) or the control group. A central block randomization method was employed. Using the SAS statistical analysis system, a random arrangement of treatments (experimental drug and control drug) for 400 subjects was generated. Specifically, a sequence of serial numbers from 001 to 400 was created, with each number corresponding to a treatment allocation. Each center was assigned a continuous block of drug codes (exceptions may occur due to case reallocation caused by progress-related reasons). Experimental Drug: Aurantii Fructus Immaturus Flavonoid Extract Tablets (Aolanti), specification: 0.29 g/tablet, provided by Jiangxi Qingfeng Pharmaceutical Co., Ltd., batch number: 20110605. Control Drug: Aurantii Fructus Immaturus Flavonoid Extract Tablets (Aolanti) placebo, specification: 0.29 g/tablet, provided by Jiangxi Qingfeng Pharmaceutical Co., Ltd., batch number: 20110605. Dosage and Administration: High-dose group: four tablets of Aurantii Fructus Immaturus Flavonoid Extract Tablets (Aolanti) per dose, taken with warm water half an hour before meals, three times a day. Medium-dose group: three tablets of Aurantii Fructus Immaturus Flavonoid Extract Tablets (Aolanti) + one placebo tablet per dose, taken with warm water half an hour before meals, three times a day. Low-dose group: two tablets of Aurantii Fructus Immaturus Flavonoid Extract Tablets (Aolanti) + two placebo tablets per dose, taken with warm water half an hour before meals, three times a day. Placebo group: four placebo tablets per dose, taken with warm water half an hour before meals, three times a day. Observation Period: Treatment Duration: 28 days. Follow-up: 28 days (only patients with all four symptoms resolved will undergo follow-up after discontinuation of the medication). |
| Intervention type | Drug |
| Pharmaceutical study type(s) | Pharmacodynamic, Dose response |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Aurantii Fructus Immaturus Flavonoid Extract Tablets (Aolanti) |
| Primary outcome measure | The percentage of disappearance of the four Western medical symptoms of functional dyspepsia (postprandial fullness, early satiation, epigastric burning, and epigastric pain) after 4 weeks of medication. 1. Functional dyspepsia symptoms (postprandial fullness, early satiation, epigastric burning) are scored as follows: 0 points: No symptoms 1 point: Mild symptoms that do not affect daily life 2 points: Moderate symptoms that do not significantly affect daily life 3 points: Persistent symptoms that significantly affect daily life 2. For epigastric pain, the Visual Analog Scale (VAS) is used: A 10-cm straight line is employed, where the 0 cm end represents "no pain" and the 10 cm end represents "the most severe pain." Patients mark the point on the line that corresponds to their level of pain. |
| Secondary outcome measures | Gastric emptying assessed using radionuclide imaging: for selected centers (West China Hospital of Sichuan University and Xiangya Hospital of Central South University), radionuclide imaging is used to assess gastric emptying function. The 2-hour gastric emptying rate and half-emptying time are observed. The test is conducted and recorded once before medication and once after 28 days of medication. The 2-hour gastric emptying rate and half-emptying time (radionuclide imaging) are compared between groups. |
| Overall study start date | 01/06/2011 |
| Completion date | 31/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 400 |
| Total final enrolment | 399 |
| Key inclusion criteria | 1. Age ≥18 years and ≤65 years, regardless of gender 2. Voluntarily participate and sign the written informed consent form 3. Meet the diagnostic criteria for functional dyspepsia 4. Discontinuation of other prokinetic agents, gastroprotective agents, or acid-suppressing drugs for at least 4 weeks prior to enrollment |
| Key exclusion criteria | 1. Individuals with organic diseases such as esophagitis, atrophic gastritis, gastric and duodenal ulcers, erosions, bleeding, tumors, etc 2. Individuals with organic diseases of the liver, gallbladder, or pancreas 3. Individuals with diabetes, kidney disease, connective tissue disease, or psychiatric disorders 4. Individuals with severe primary diseases of the heart, brain, lungs, kidneys, hematopoietic system, or endocrine system 5. Individuals with a history of abdominal surgery 6. Individuals with renal insufficiency, with creatinine (Cr) levels above the upper limit of normal 7. Individuals with hepatic insufficiency, with AST and/or ALT levels 1.5 times the upper limit of normal 8. Pregnant women, those with pregnancy intentions, or women who are breastfeeding 9. Individuals with mental or legal disabilities 10. Individuals who have participated in other drug clinical trials within the 3 months prior to this trial |
| Date of first enrolment | 19/10/2011 |
| Date of final enrolment | 25/09/2012 |
Locations
Countries of recruitment
- China
Study participating centres
Wuhou District
Chengdu
610041
China
Jinniu District
Chengdu
610072
China
Furong District
Changsha
410007
China
Kaifu District
Changsha
410008
China
Xihu District
Nanchang
330006
China
Nankai District
Tianjin
300193
China
Hebei District
Tianjin
300150
China
Sponsor information
Industry
Shahe Industrial Park
Ganzhou
341000
China
| Phone | +86 (0)797 5560800 |
|---|---|
| yxpv@qfyy.com.cn | |
| Website | https://www.qfyy.com.cn/ |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The aggregated research data will be stored by the sponsor as required. The original research data will be retained at each research center in accordance with regulations. Interested parties may submit a request to the sponsor as needed, and the sponsor will provide relevant content based on actual circumstances.(Contact: Qi,qitiancheng@qfyy.com.cn) |
Editorial Notes
25/02/2025: Study's existence confirmed by the Clinical Trial Ethics Committee of West China Hospital of Sichuan University.
