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RCT study on the intervention of visceral sensitivity in patients with non erosive gastroesophageal reflux disease combined with anxiety and depression using Xin Kai Ku Jiang method

RCT study on the intervention of visceral sensitivity in patients with non erosive gastroesophageal reflux disease combined with anxiety and depression using Xin Kai Ku Jiang method

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074340
Enrollment
Unknown
Registered
2023-08-03
Start date
2023-09-01
Completion date
Unknown
Last updated
2023-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non -erosion gastroesophageal reflux disease

Interventions

the Test group:Administer Xin Kai Ku Jiang Fa formula granules (9g of Pinellia ternata, 10g of Scutellaria baicalensis, 8g of Coptis chinensis, 3g of Fructus Evodiae, 10g of Radix Pseudostellariae, 10
At the same time, take orally pantoprazole enteric coated capsule simulant, once a time, once a day
Oral administration of flupenthizumab and melitracin tablets (Deanxit) as a simulated agent, taking 1 tablet in the morning and 1 tablet in the afternoon. The treatment period is 4 weeks.
the Control group:Give Pantoprazole enteric coated capsules (40mg × 7 pieces/box) orally, 1 piece/time, 1 time/day
Flupenthizumab Melitracen Tablets (Deanxit, 0.5mg: 10mg) × 20 tablets/box) orally, 1 tablet in the morning and 1 tablet in the afternoon
Simultaneously take a traditional Chinese medicine formula particle simulation agent (mainly composed of dextrin shaper, added to 1/10 of the treatment group's traditional Chinese medicine dose to ret

Sponsors

Beijing Xuanwu Traditional Chinese Medical Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The clinical symptoms meet the diagnostic criteria of traditional Chinese medicine and Western medicine for NERD combined with mild to moderate anxiety and depression; 2. Between the ages of 18 and 65, regardless of gender; 3. No severe anxiety or depression, no suicidal tendencies; 4. The subject is informed and voluntarily signs an informed consent form.

Exclusion criteria

Exclusion criteria: Patients with gastric organic diseases such as erosive gastritis, gastric ulcer, and duodenal ulcer; Pregnant and lactating women; People with connective tissue diseases, diabetes and other endocrine and metabolic diseases, and menopausal syndrome; Individuals with severe primary heart, liver, lung, kidney, blood or serious diseases that affect their survival; Disabled patients (blind, deaf, mute, intellectually disabled, mentally disabled, physically disabled) as stipulated by law; Suspected or confirmed history of alcohol or drug abuse; According to the judgment of the researcher, other pathological changes that reduce the likelihood of enrollment or complicate enrollment, such as frequent changes in the work environment, may lead to loss of follow-up; Allergic constitution, such as a history of allergies to two or more drugs or foods; Or known to be allergic to the ingredients of this medicine; Patients participating in clinical trials of other drugs; Patients who are in a state of severe anxiety and depression and have a tendency to commit suicide.

Design outcomes

Primary

MeasureTime frame
Main symptom score;Hamilton Anxiety Scale;Hamilton Depression Scale;

Secondary

MeasureTime frame
cholecystokinin;motilin;multi-channel impedance pH detection values;Electrogastrography ;substance P;5-hydroxytryptamine;dopamine;interleukin-6;interleukin-10;Calcitonin gene related peptide;

Countries

china

Contacts

Public Contactlai yao liang

Beijing Xuanwu Traditional Chinese Medical Hospital

yaoliang010@126.com+86 136 9144 6877

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026