Functional DyspepsiaNCT04548011
Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia
A study testing Acupuncture in people with Functional Dyspepsia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
Trial summary
The objective of this trial is to assess acupuncture of different treatment frequency on improving quality of life in patients with functional dyspepsia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of FD as defined by the Roman IV Functional Dyspepsia Diagnostic criteria
- One or more of the following:
- Bothersome postprandial fullness
- Bothersome early satiation
- Bothersome epigastric pain
- Bothersome epigastric burning AND No evidence of structural disease (including at upper endoscopy) that is likely to explain the symptoms Epigastric Pain Syndrome (EPS) criteria: fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.
Show all 9Show fewer
- Postprandial Distress Syndrome Diagnostic (PDS) criteria: must include one or both of the following at least 3 days per week:
- Age 18-75 years.
- Signed informed consent and volunteered to participate in the trial.
Who cannot join
- Candidate participants with any of the following items will be excluded from this trial.
- Gastrointestinal motility drugs taken within the past 15 days; Acupuncture treatments within the past 30 days; participating in other ongoing clinical trials
- Severe heart, lung, liver, brain or kidney damage.
- Would-be mothers, pregnant or lactation;
- Progressive malignant tumor or other severe consumptive diseases, easy to be complicated with bleeding and infection;
- Cognitive impairment such as unable to express subjective symptoms of discomfort or give informed consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia: a Three-armed Randomized Controlled Trial
The objective of this trial is to assess acupuncture of different treatment frequency on improving quality of life in patients with functional dyspepsia.
Read the detailed description
The effect of treatment frequency of acupuncture on the functional dyspepsia is unclear. In this study, 60 participants with FD will be recruited and randomly allocated (using a 1:1:1 allocation ratio) into three times a week group, once a week group and waiting for treatment group. Participants will receive acupuncture treatment at bilateral Zhongwan（CV12）, Tianshu（ST25）, Neiguan（PC6）, Liangqiu（ST34）, Yanglinquan（GB34）, Zusanli（ST36）and Taichong（LR3) of different treatment frequency for 4 weeks. This trial is designed to analyze the acupuncture of different treatment frequency on improving quality of life in patients with FD and to provide evidence for the establishment of acupuncture treatment quantization standard of FD.
- Conditions
- Functional Dyspepsia
- Being tested
- Acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
The acupuncture treatment strategies in this study are based on traditional Chinese medicine theory and opinions from the acupuncture experts. The acupoints are bilateral Zhongwan（CV12）, Tianshu（ST25）, Neiguan（PC6）, Liangqiu（ST34）, Yanglinquan（GB34）, Zusanli（ST36）and Taichong（LR3）.All the acupoints will be localized according to the Nomenclature and Location of Acupuncture Points of the People's Republic of China. During the acupuncture treatment, the participants will be in supine position. After 75% alcohol pads sterilizing the skin around the acupoints routinely, the acupuncturists will use sterile disposable steel needles (0.3 mm×40 mm; Huatuo Brand, Suzhou Medical Appliance, China) to insert into the acupoints above. The acupoints will be inserted vertically at 13-40 mm with the manipulation of steady small lifting, thrusting, and twirling 3 times to induce a sensation of de qi (sourness, numbness, and heaviness).
| Study group | Role | What they receive |
|---|---|---|
| Three times a week group | Experimental | Twenty participants in three times a week group will receive acupuncture treatment 3 times per week (every other day) for 4 weeks, 12 sessions totally. The acupuncture operation as above. Participants will not be not allowed to take any other medication or accept any treatment for FD. should not be accepted during the study. In case of unbearable symptoms, the assistant researchers will detailly document. Receives: Other: Acupuncture |
| Once a week group | Experimental | Twenty participants in once a week group will receive acupuncture treatment 1 time per week for 4 weeks (Weekly fixed day), 4 sessions totally. Other inventions will be same as the Three times a week group. Receives: Other: Acupuncture |
| Waiting for treatment group | No intervention | After the health education（such as dietary adjustment for FD patients）, the participants will be followed up for 4 weeks. At the end of the follow-up, the patients could be given free acupuncture treatment (the invention will be similar with that of the Three times a week group) for 4 weeks at will. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The score change in Nepean Dyspepsia Life Quality Index compared with baseline at week 4
The primary outcome is the score change in Nepean Dyspepsia Life Quality Index （NDLQI）compared with baseline at week 4. The NDLQI is a scale of 25 items about the quality of the patients' life with a ranging score of 1-4 of each item. The higher scores indicates a worse outcome.
Measured: week 4
Secondary outcomes (5)
The score change in NDLQI compared with baseline
The score change in NDLQI compared with baseline at weeks 2, 8 and 12. The NDLQI is a scale of 25 items about the quality of the patients' life with a ranging score of 1-4 of each item. The higher scores indicates a worse outcome.
Measured: week 2, week 8 and week 12
The score of each dimension change in NDLQI compared with baseline
The score of each dimension change in NDLQI compared with baseline at weeks 4, 8 and 12. The NDLQI is a scale of 25 items about the quality of the patients' life with a ranging score of 1-4 of each item. The higher scores indicates a worse outcome.
Measured: week 4, week 8 and week 12
The total score change in Symptom Index of Dyspepsia （SID）
The total score change in Symptom Index of Dyspepsia （SID） compared with baseline at weeks 4, 8 and 12. SID is a four-rate scale with a ranging score of 0-4 of each dyspepsia symptoms (postprandial distension; early satiety; epigastric pain; and epigastric burning). The higher scores indicates a worse outcome.
Measured: week 4, week 8 and week 12
The standard score change in Self-Rating Anxiety Scale（SAS）
The standard score change in Self-Rating Anxiety Scale（SAS） compared with baseline at weeks 4, 8 and 12. SAS is a scale of 20 items about the anxiety level of patients with a ranging score of 1-4 of each question. The higher scores indicates a worse outcome.
Measured: week 4, week 8 and week 12
6. The standard score change in Self-Rating Depression Scale （SDS）
The standard score change in Self-Rating Depression Scale （SDS） compared with baseline at weeks 4, 8 and 12. SAS is a scale of 20 items about the depression level of patients with a ranging score of 1-4 of each question. The higher scores indicates a worse outcome.
Measured: week 4, week 8 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2020
- Study startOct 2020 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biyun Sun, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548011
- Sponsor's protocol ID
- GAMHospital20200906
- Status last verified
- Sep 2020
- First submitted
- 6 Sep 2020
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia: a Three-armed Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04548011
- Acronym / sponsor ID
- GAMHospital20200906
- Conditions
- Functional Dyspepsia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 14 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to assess acupuncture of different treatment frequency on improving quality of life in patients with functional dyspepsia.
Detailed description
The effect of treatment frequency of acupuncture on the functional dyspepsia is unclear. In this study, 60 participants with FD will be recruited and randomly allocated (using a 1:1:1 allocation ratio) into three times a week group, once a week group and waiting for treatment group. Participants will receive acupuncture treatment at bilateral Zhongwan（CV12）, Tianshu（ST25）, Neiguan（PC6）, Liangqiu（ST34）, Yanglinquan（GB34）, Zusanli（ST36）and Taichong（LR3) of different treatment frequency for 4 weeks. This trial is designed to analyze the acupuncture of different treatment frequency on improving quality of life in patients with FD and to provide evidence for the establishment of acupuncture treatment quantization standard of FD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Three times a week group | Experimental | Other: AcupunctureTwenty participants in three times a week group will receive acupuncture treatment 3 times per week (every other day) for 4 weeks, 12 sessions totally. The acupuncture operation as above. Participants will not be not allowed to take any other medication or accept any treatment for FD. should not be accepted during the study. In case of unbearable symptoms, the assistant researchers will detailly document. |
| Once a week group | Experimental | Other: AcupunctureTwenty participants in once a week group will receive acupuncture treatment 1 time per week for 4 weeks (Weekly fixed day), 4 sessions totally. Other inventions will be same as the Three times a week group. |
| Waiting for treatment group | No intervention | –After the health education（such as dietary adjustment for FD patients）, the participants will be followed up for 4 weeks. At the end of the follow-up, the patients could be given free acupuncture treatment (the invention will be similar with that of the Three times a week group) for 4 weeks at will. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Diagnosis of FD as defined by the Roman IV Functional Dyspepsia Diagnostic criteria
- Postprandial Distress Syndrome Diagnostic (PDS) criteria: must include one or both of the following at least 3 days per week:
- Age 18-75 years.
- Signed informed consent and volunteered to participate in the trial.
Key exclusion criteria (6 listed)
- Candidate participants with any of the following items will be excluded from this trial.
- Gastrointestinal motility drugs taken within the past 15 days; Acupuncture treatments within the past 30 days; participating in other ongoing clinical trials
- Severe heart, lung, liver, brain or kidney damage.
- Would-be mothers, pregnant or lactation;
- Progressive malignant tumor or other severe consumptive diseases, easy to be complicated with bleeding and infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureThe acupuncture treatment strategies in this study are based on traditional Chinese medicine theory and opinions from the acupuncture experts. The acupoints are bilateral Zhongwan（CV12）, Tianshu（ST25）, Neiguan（PC6）, Liangqiu（ST34）, Yanglinquan（GB34）, Zusanli（ST36）and Taichong（LR3）.All the acupoints will be localized according to the Nomenclature and Location of Acupuncture Points of the People's Republic of China. During the acupuncture treatment, the participants will be in supine position. After 75% alcohol pads sterilizing the skin around the acupoints routinely, the acupuncturists will use sterile disposable steel needles (0.3 mm×40 mm; Huatuo Brand, Suzhou Medical Appliance, China) to insert into the acupoints above. The acupoints will be inserted vertically at 13-40 mm with the manipulation of steady small lifting, thrusting, and twirling 3 times to induce a sensation of de qi (sourness, numbness, and heaviness). | Other | Once a week group, Three times a week group |
Primary outcome
The score change in Nepean Dyspepsia Life Quality Index compared with baseline at week 4
Time frame: week 4
The primary outcome is the score change in Nepean Dyspepsia Life Quality Index （NDLQI）compared with baseline at week 4. The NDLQI is a scale of 25 items about the quality of the patients' life with a ranging score of 1-4 of each item. The higher scores indicates a worse outcome.
5 secondary outcomes
The score change in NDLQI compared with baseline
Time frame: week 2, week 8 and week 12
The score of each dimension change in NDLQI compared with baseline
Time frame: week 4, week 8 and week 12
The total score change in Symptom Index of Dyspepsia （SID）
Time frame: week 4, week 8 and week 12
The standard score change in Self-Rating Anxiety Scale（SAS）
Time frame: week 4, week 8 and week 12
6. The standard score change in Self-Rating Depression Scale （SDS）
Time frame: week 4, week 8 and week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
Related trials for Functional Dyspepsia
Active, not recruitingPhase 1
AutoSTEA for Adults With Functional Dyspepsia
Functional Dyspepsia
Recruiting
Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)
Functional Dyspepsia
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
RecruitingPhase 4
Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia
Functional Dyspepsia, Probiotics
RecruitingPhase 2
Exploring Novel Therapeutic Approaches for Disorders of Gut-Liver-Brain Interaction-H1/H2
Functional Gastrointestinal Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Functional Dyspepsia, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Biyun Sun (+86 17801411206, sun04161206@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The score change in Nepean Dyspepsia Life Quality Index compared with baseline at week 4 (time frame: week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.