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The Clinical Research of Glous hystericus

Clinical efficacy and Safety of Flupentixol and Melitracen Tablets in Treating Glous hystericus

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006877
Enrollment
Unknown
Registered
2015-08-03
Start date
2015-09-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Glous hystericus

Interventions

Group A:Pantoprazole Enteric-Coated Tablets + Itopride Hydrochloride Tablets Or Alprazolam
Group C:Flupentixol and Melitracen Tablets + Pantoprazole Enteric-Coated Tablets + Itopride Hydrochloride Tablets Or Flupentixol and Melitracen Tablets + Alprazolam

Sponsors

The First Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 76 Years

Inclusion criteria

Inclusion criteria: 1. The patients with clinical symptoms accords with diagnostic criteria Rome III, all the following qualifications must be included: (1) With continuous or discontinuous painless crumb or pharyngeal paraesthesias; (2) With sensation between meals; (3) Without dysphagia or odynphagia; (4) Without evidence of correlation between gastroesophageal reflux and clinical symptoms; (5) Without esophageal motor dysfunction based on histopathology. Those symptoms are existed at least 6 months before diagnosis, and met the criterion for almost three months. 2. Mild to moderate anxiety or depression: Hamilton anxiety scale(HAMA)score 8-35; Hamilton depressive scale(HAMD)score 7-29; Hospital anxiety and depression scale(HAD)score 8-15; Self rating anxiety scale(SAS)score 50-70; Self rating depression scale(SDS)score 50-70. Patients with any condition above, could be brought into group. (This criteria is not prerequisite, B or C is acceptable.) 3. Age: 18-70; 4. Drug history: Patients that were or being used with anti-anxiety-depression drug should get through the cleaning phase (Cleaning phase = drug's half-time*5, like the half-time of Flupentixol and Melitracen Tablets is 7 days, its cleaning phase should be 35 days).

Exclusion criteria

Exclusion criteria: 1. Patients with severe psychical and psychological diseases (serious depression, anxiety, personality disorder or suicide inclination, if visual or auditory hallucination appeals, it's better to transferred to psychiatric departments); 2. Patients with (critical) organic lesion in gastrointestinal, liver, gallbladder, pancreas, heart, kidney,etc. Patients with infectious, hereditary, metabolic, endocrine, autoimmune diseases etc.; 3. Patients with allergic history, alcohol or drug abuse history; 4. Patients with badly heart diseases, like early recovery of acute myocardial infarction(AMI), bundle branch block; Patients with untreated narrow cleft glaucoma; Patients with highly excitation; Patients with acute alcohol, barbiturates, opium intoxication; Patients during pregnancy and lactation.

Design outcomes

Primary

MeasureTime frame
Symptom score of Glous hystericus (ten-point calibration);Safety Evaluation (TESS side effect rating scale);

Countries

China

Contacts

Public ContactSenlin Zhu
zhusl@mail.sysu.edu.cn+86 13533344661

Outcome results

None listed

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