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A randomized, double-blind and placebo-controlled clinical trial of duloxetine hydrochloride enteric-coated tablets in the treatment of refractory cough complicated with somatic disorder

A randomized, double-blind and placebo-controlled clinical trial of duloxetine hydrochloride enteric-coated tablets in the treatment of refractory cough complicated with somatic disorder

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037429
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-13

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

Conditions

Refractory cough with physical symptom disorder

Interventions

Control group:Placebo of duloxetine hydrochloride enteric-coated tablets
Experimental group:duloxetine hydrochloride enteric-coated tablets

Sponsors

Shanghai Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Before any evaluation, the patient or his legal representative must sign an informed consent form; 2. Aged 18 to 60 years old; 3. With cough as the main symptom, the coughing time is longer than 8 weeks and there is no obvious abnormality in the front and side view of the chest; according to the Chinese "Guidelines for the Diagnosis and Treatment of Cough (2015)", the chronic cough diagnostic procedure is still unable to clarify the cause or Patients with chronic cough who have not been relieved after treatment with a known cause; 4. Subject's Cough Visual Analogue Scale (VAS) >=30mm; 5. Compliance with the diagnostic criteria of the fifth edition of the American Diagnostic and Statistical Manual of Mental Disorders (DSM-5) somatic disorder: (1) Having one or more physical symptoms, causing obvious mental pain or significantly disrupting the patient's daily life; (2) Targeting Physical symptoms or related health concerns, excessive thinking, feeling or behavior, manifested as one of the following phenomena: 1) There is a persistent and disproportionate thought about the severity of one's symptoms; 2) There is a persistently high level of health or symptoms Anxiety, ? put too much time and energy into these symptoms or health concerns; 3) Although a certain physical symptom may not persist, the symptomatic state is persistent (typically longer than 6 months); 6. B Standard Scale for Diagnosis of Physical Disorders (SSD-12) >=16 points, Rapid Depressive Symptom Rating Scale (QIDS-SR16) >=11 points, General Anxiety Scale (GAD-7) >=10 Points.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women or those who refuse to sign an informed consent form. 2. Smoking or quitting Smoking for <=2 years;. 3. History of respiratory infection within 8 weeks; 4. Patients with renal insufficiency, pregnant women and lactating women; 5. Patients who need to take ACEI drugs for a long time; 6. Other psychotic disorders or drug addicts; 7. People with hypertension and other cardiovascular diseases; 8. The researchers believe that there are other situations that are not suitable for entering the study.

Design outcomes

Primary

MeasureTime frame
Cough visual simulation score;Leicester Quality of Life Questionnaire scores;

Secondary

MeasureTime frame
Capsaicin cough sensitivity;Somatic symptom disorder B Standard Scale;Rapid Rating Scale for depressive symptoms;Generalized Anxiety Scale;

Countries

China

Contacts

Public ContactXiang-Huai Xu

Shanghai Tongji Hospital

05849@tongji.edu.cn+86 13764459488

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 10, 2026