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

NCT04548011 | Unknown

• 1 other identifier: GAMHospital20200906
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• 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.

  week 4

Secondary Outcomes (5)

• The score change in NDLQI compared with baseline

  week 2, week 8 and week 12

• The score of each dimension change in NDLQI compared with baseline

  week 4, week 8 and week 12

• The total score change in Symptom Index of Dyspepsia （SID）

  week 4, week 8 and week 12

• The standard score change in Self-Rating Anxiety Scale（SAS）

  week 4, week 8 and week 12

• 6. The standard score change in Self-Rating Depression Scale （SDS）

  week 4, week 8 and week 12

Study Arms (3)

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.

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.

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.

Interventions

Acupuncture OTHER

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).

Once a week group; Three times a week group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Biyun Sun

CONTACT

+86 17801411206; sun04161206@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Acupuncture doctor in Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Study Record Dates

• First Submitted: September 6, 2020
• First Posted: September 14, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: December 1, 2022
• Last Updated: September 16, 2020

Record last verified: 2020-09