Efficacy and safety of Hou Gu Mi Xi rice paste on improving the symptoms of indigestion
| ISRCTN | ISRCTN17174559 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17174559 |
- Submission date
- 30/06/2022
- Registration date
- 06/07/2022
- Last edited
- 08/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
Functional dyspepsia (FD), a kind of chronic indigestion, is defined by symptoms that are centered in the upper abdomen (the gastroduodenal region) without any underlying disease that might explain these symptoms. Jiangzhong Hou Gu Mi Xi® (HGMX) rice paste, a dietary traditional Chinese medicine (TCM) formula, is modified from the classic TCM Shen Ling Bai Zhu San formula. This study aims to explore the efficacy and safety of HGMX rice paste on the clinical symptoms of FD and to put forward some suggestions on dietary therapy with HGMX rice paste.
Who can participate?
Adults with FD
What does the study involve?
Participants are given health education and guidance on the use, dose, and precautions to take when consuming the rice paste. Rice paste is distributed at the beginning of the first month. Without affecting their normal diet, the participants will consume either one complete packet (30g) per day of HGMX or one complete packet (30g) per day of a dummy (placebo) product for 2 months under the supervision of the researcher's WeChat. Using WeChat, participants are asked to answer questions about their FD symptoms and quality of life, and other physical measurement indicators on the 15th, 30th, and 60th days after treatment, and at follow-up at 1 month after the expiration of the intervention. Participants are also asked for feedback and their feelings about the entire trial. The reasons for dropouts or withdrawals of participants are recorded in the case report form there is monitoring for any adverse events (AEs) and severe AEs (SAEs) throughout the entire trial period using a standard adverse event case report form.
What are the possible benefits and risks of participating?
Participants will benefit from HGMX and may get some compensation. There are risks associated with drawing blood.
Where is the study run from?
Beijing Shijitan Hospital, Capital Medical University (China)
When is the study starting and how long is it expected to run for?
January 2019 to April 2023
Who is funding the study?
Chinese Institute of Food Science and Technology, Food Science and Technology Fund (China)
Who is the main contact?
Dr Xin Wang (China)
winsun2011@163.com
Contact information
Principal Investigator
Beijing Shijitan Hospital
Capital Medical University
10 Tieyi Road
Yangfangdian Haidian District
Beijing
100038
China
 ORCID ID |
0000-0003-0431-8211 |
|---|---|
| Phone | +86 15717517447 |
| winsun2011@163.com |
Study information
| Study design | Single-center single-dose prospective randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Efficacy and Safety of Hou Gu Mi Xi Rice Paste on Improving the Symptoms of Functional Dyspepsia: A Randomized, Placebo-Controlled, Clinical Trial |
| Study objectives | Hou Gu Mi Xi rice paste will provide an effective and safe method to improve the symptoms and quality of life in patients with functional dyspepsia |
| Ethics approval(s) | Approved 26/05/2022, Clinical Research Ethics Committee of Beijing Shijitan Hospital (10 Tieyi Road, Yangfangdian Haidian District, Beijing, China; +86 (0)10 63926603; sjtkyll@126.com), ref: sjtkyll-lx-2020 (1) |
| Health condition(s) or problem(s) studied | Functional dyspepsia |
| Intervention | Before starting the intervention, researchers will provide health education to the subjects and give face-to-face guidance on the usage, dosage, and precautions of rice paste. Rice paste will be distributed at the beginning of the first month. Without affecting the normal diet, subjects would complete either one packet (30g) /day HGMX or one packet (30g)/day placebo, taken orally for a 2-month intervention under the supervision of the researcher's WeChat. Participants attend investigations, including global overall symptom scale (GOSS), 36-Item Short Form Survey (SF-36), body mass index (BMI), and other physical measurement indicators on the 15th, 30th, and 60th days after treatment, and follow-up at 1 month after the expiration of the intervention including GOSS, SF-36, BMI, other physical measurement indicators, feedback, and feelings about the entire trial. The form of the questionnaire is a WeChat answer sheet. Participants do not need to come to the hospital to complete the investigation at the time points except for baseline investigation. At the end of the test, it is necessary to take pictures of the remaining packaging bags of rice paste for two months to understand the completion of the test. The reasons for dropouts or withdrawals of participants would be recorded in the case report form. We will monitor any adverse events (AEs) and severe AEs (SAEs) throughout the entire trial period using a standard adverse event case report form. |
| Intervention type | Supplement |
| Primary outcome measure | Overall severity of dyspepsia symptoms measured using the 7-point global overall symptom scale (GOSS) at baseline (0 day), 15th, 30th, and 60th days after treatment, and follow-up at 1 month after the expiration of the intervention |
| Secondary outcome measures | Quality-of-life, adverse reactions and other indicators measured using the 36-Item Short Form Survey (SF-36) at baseline (0 day), 15th, 30th, and 60th days after treatment, and follow-up at 1 month after the expiration of the intervention |
| Overall study start date | 08/01/2019 |
| Completion date | 08/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 64 |
| Key inclusion criteria | 1. Aged 18 to 80 years old with no gender restrictions 2. Meet the diagnostic criteria for functional dyspepsia in Rome III (the absence of organic dyspepsia confirmed by endoscope) 3. Normal gastroscopy results in the past 1 year, and no other organic lesions in the gastrointestinal tract 4. No mental illness (Mini Mental State Questionnaire, MMSE ≥ 20) 5. Able to take food orally 6. Volunteered to accept intervention and signed the informed consent 7. Compliance with treatment completion and follow-up |
| Key exclusion criteria | 1. Severe cognitive impairment 2. Abnormal electrocardiogram 3. Organic digestive tract disease 4. History of gastrointestinal surgery 5. Diabetes 6. Malignant tumors 7. Other diseases 8. Taking traditional Chinese medicine preparations 9. Pregnancy and breast-feeding or planning to become pregnant within 6 months 10. History of allergic reactions related to Chinese medicine or rice paste 11. Impairment of liver and kidney function: 11.1 Total bilirubin, alanine aminotransferase or aspartate aminotransferase> 2 times the upper limit of normal 11.2. Serum creatinine> 2 times the upper limit of normal 12. Drugs that affect digestive function taken within the past month and during the study period: 12.1. Gastrointestinal motility drugs 12.2. Anti-Helicobacter pylori drugs 12.3. Antidepressants 12.4. Antianxiety drugs 12.5. Acid-suppressing drugs (PPIs and H2 receptor blockers) 13. A place of residence that is too far, unwilling or unable to complete the return visit 14. H. pylori positive by Carbon-13 urea breath test at the time of screening. |
| Date of first enrolment | 08/01/2022 |
| Date of final enrolment | 08/01/2023 |
Locations
Countries of recruitment
- China
Study participating centre
10 Tieyi Road
Yangfangdian Haidian District
Beijing
100038
China
Sponsor information
Hospital/treatment centre
Capital Medical University
10 Tieyi Road
Yangfangdian Haidian District
Beijing
100038
China
| Phone | +86 010 63926603 |
|---|---|
| sjtkyll@126.com | |
| Website | https://www.bjsjth.cn/ |
"ROR" |
https://ror.org/0569k1630 |
Funders
Funder type
Research organisation
Government organisation / Universities (academic only)
- Alternative name(s)
- 中国农业科学院, 中國農業科學院, CAAS
- Location
- China
Results and Publications
| Intention to publish date | 04/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 07/01/2024 | 08/03/2024 | Yes | No |
Editorial Notes
08/03/2024: Publication reference and total final enrolment added.
07/03/2024: The following changes were made to the trial record:
1. The recruitment end date was changed from 05/01/2024 to 08/01/2023.
2. The overall end date was changed from 05/04/2024 to 08/04/2023.
3. The intention to publish date was changed from 08/01/2025 to 04/01/2024.
4. The plain English summary was updated to reflect these changes.
05/07/2022: Trial's existence confirmed by the Clinical Research Ethics Committee of Beijing Shijitan Hospital.
