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Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia

Primary Purpose

Functional Dyspepsia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Functional Dyspepsia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosis of FD as defined by the Roman IV Functional Dyspepsia Diagnostic criteria

    One or more of the following:

    1. Bothersome postprandial fullness
    2. Bothersome early satiation
    3. Bothersome epigastric pain
    4. 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.

    Postprandial Distress Syndrome Diagnostic (PDS) criteria: must include one or both of the following at least 3 days per week:

  2. Age 18-75 years.
  3. Signed informed consent and volunteered to participate in the trial.

Exclusion Criteria:

Candidate participants with any of the following items will be excluded from this trial.

  1. Gastrointestinal motility drugs taken within the past 15 days; Acupuncture treatments within the past 30 days; participating in other ongoing clinical trials
  2. Severe heart, lung, liver, brain or kidney damage.
  3. Would-be mothers, pregnant or lactation;
  4. Progressive malignant tumor or other severe consumptive diseases, easy to be complicated with bleeding and infection;
  5. Cognitive impairment such as unable to express subjective symptoms of discomfort or give informed consent.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Three times a week group

    Once a week group

    Waiting for treatment group

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.

    Full Information

    First Posted
    September 6, 2020
    Last Updated
    September 13, 2020
    Sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04548011
    Brief Title
    Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia
    Official Title
    Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia: a Three-armed Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2020 (Anticipated)
    Primary Completion Date
    October 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Guang'anmen Hospital of China Academy of Chinese Medical Sciences

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Functional Dyspepsia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Three times a week group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Once a week group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Waiting for treatment group
    Arm Type
    No Intervention
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Acupuncture
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    The score change in Nepean Dyspepsia Life Quality Index compared with baseline at week 4
    Description
    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.
    Time Frame
    week 4
    Secondary Outcome Measure Information:
    Title
    The score change in NDLQI compared with baseline
    Description
    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.
    Time Frame
    week 2, week 8 and week 12
    Title
    The score of each dimension change in NDLQI compared with baseline
    Description
    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.
    Time Frame
    week 4, week 8 and week 12
    Title
    The total score change in Symptom Index of Dyspepsia （SID）
    Description
    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.
    Time Frame
    week 4, week 8 and week 12
    Title
    The standard score change in Self-Rating Anxiety Scale（SAS）
    Description
    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.
    Time Frame
    week 4, week 8 and week 12
    Title
    6. The standard score change in Self-Rating Depression Scale （SDS）
    Description
    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.
    Time Frame
    week 4, week 8 and week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Biyun Sun
    Phone
    +86 17801411206
    Email
    sun04161206@163.com

    12. IPD Sharing Statement

    Learn more about this trial

    Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia

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