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A Randomized Controlled Clinical Study of Minaprine Hydrochloride Tablets Monotherapy or Combined with Cognitive Behavioral Therapy in the Treatment of Refractory Cough

A Randomized Controlled Clinical Study of Minaprine Hydrochloride Tablets Monotherapy or Combined with Cognitive Behavioral Therapy in the Treatment of Refractory Cough

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102749
Enrollment
Unknown
Registered
2025-05-19
Start date
2025-05-31
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

Chronic cough

Interventions

Control Group:Patients receive oral gabapentin capsules only. The initial dose is 50 mg per day, administered twice daily (25 mg in the morning and 25 mg in the evening). After three days, the dose is
Milnacipran Group:Patients receive oral milnacipran hydrochloride tablets only. The initial dose is 50 mg per day, administered twice daily (25 mg in the morning and 25 mg in the evening). After three
Milnacipran + CBT Group:Patients receive oral milnacipran hydrochloride tablets (administered as in the Milnacipran Group) combined with CBT (Cognitive Behavioral Therapy) once per week, with each ses

Sponsors

Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: a. Age between 18 and 70 years (inclusive), with no restriction on gender. b. Cough is the primary symptom, with a duration of more than 2 months, and chest imaging showing no significant abnormalities. c. Patients with refractory cough who, after a comprehensive evaluation following the Guidelines for the Diagnosis and Treatment of Cough (2021) issued by the Asthma Group of the Chinese Thoracic Society, either have no identified cause or experience no relief despite treatment for a known cause. d. Total cough symptom score >= 3. e. Participants fully understand the purpose of the study, are willing and able to comply with the study requirements, and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: a. Pregnant or breastfeeding women. b. Individuals who are currently smoking or have quit smoking within the past 2 years. c. History of psychological therapy or psychiatric medication use within the past 3 months. d. History of new-onset respiratory tract infection within the past 8 weeks. e. Contraindications to or history of allergy to Milnacipran. f. Presence of severe underlying diseases.

Design outcomes

Primary

MeasureTime frame
Cough Visual Analog Scale (VAS) Score;24-Hour Cough Frequency Record;Cough Symptom Score (CSS);Leicester Cough Questionnaire (LCQ);Hull Airway Reflux Questionnaire (HARQ);Newcastle Laryngeal Hypersensitivity Questionnaire (NLHQ);Capsaicin Cough Sensitivity Test (Capsaicin Cough Challenge);Psychological Assessment Scales;Brain Functional Magnetic Resonance Imaging (fMRI);

Countries

China

Contacts

Public ContactTongyangzi Zhang

Department of Pulmonary and Critical Care Medicine, Tongji Hospital, School of Medicine, Tongji University, Shanghai, China.

2111718@tongji.edu.cn+86 139 5101 6877

Outcome results

None listed

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