Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04548011
Other study ID # GAMHospital20200906
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04656730 - Effect of STW5 (Iberogast ®) and STW5-II (Iberogast N®) on Transit and Tolerance of Intestinal Gas Phase 4
Completed NCT04464369 - Functional Dyspepsia: Validation of the Leuven Postprandial Distress Scale (LPDS) in a Placebo-controlled Trial Phase 4
Completed NCT01671670 - Acupuncture for Patients With Function Dyspepsia Phase 2/Phase 3
Completed NCT00987805 - Efficacy of Banhasasim-tang on Functional Dyspepsia Phase 4
Completed NCT00761358 - To Verify the Efficacy of Z-338 in Subjects With Functional Dyspepsia Phase 3
Completed NCT00693407 - Study of Endogenous Inhibitory Modulation During Gastric and Somatic Stimulation N/A
Recruiting NCT01240096 - Mirtazapine Versus Placebo in Functional Dyspepsia Phase 4
Recruiting NCT04540549 - Effects of Exercise on Functional Dyspepsia Based on Rome IV N/A
Recruiting NCT03652571 - Nortriptyline for the Treatment of Functional Dyspepsia Phase 3
Recruiting NCT06068114 - Gastric Pathophysiology in Diabetes
Recruiting NCT03825692 - International Clinical Study of Zhizhu Kuanzhong Capsule Phase 4
Terminated NCT02567578 - A Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia Phase 2
Completed NCT03007433 - Assessment of GI Function to a Large Test Meal by Non-invasive Imaging N/A
Active, not recruiting NCT00990405 - Clinical Study to Evaluate the Efficacy and the Safety of Eradication Therapy for Helicobacter Pylori in Functional Dyspepsia Phase 4
Completed NCT00404534 - Helicobacter Eradication Relief of Dyspeptic Symptoms Phase 3
Completed NCT03043625 - Visceral Manipulation Treatment to Patients With Non-specific Neck Pain With Functional Dyspepsia N/A
Completed NCT03225248 - Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia Phase 3
Recruiting NCT05587127 - Exposure-Based CBT for Avoidant/Restrictive Food Intake in Functional Dyspepsia N/A
Recruiting NCT01021475 - Does Visceral Manipulation Works in Treating Functional Dyspepsia? Phase 1
Completed NCT00599677 - Randomized Controlled Trial of Acupuncture for Functional Dyspepsia N/A