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

Functional Dyspepsia Clinical Trial

Official title:

Acupuncture of Different Treatment Frequency on Improving Quality of Life in Patients With Functional Dyspepsia: a Three-armed Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04548011
• Other study ID #: GAMHospital20200906
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2020
• Est. completion date: December 2022

Study information

• Verified date: September 2020
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Biyun Sun
• Phone: +86 17801411206
• Email: sun04161206[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Functional Dyspepsia

Intervention

Other:
• Acupuncture
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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	week 2, week 8 and week 12
Secondary	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.	week 4, week 8 and week 12
Secondary	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.	week 4, week 8 and week 12
Secondary	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.	week 4, week 8 and week 12
Secondary	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.	week 4, week 8 and week 12