A randomized double blind placebo parallel-controlled multi-center study protocol of post-stroke thalamic pain for the treatment of wishful-treasure pill

A randomized double blind placebo parallel-controlled multi-center study of post-stroke thalamic pain for the treatment of wishful-treasure pill

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2025001598

Enrollment

Unknown

Registered

2025-08-21

Start date

2025-08-27

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

post-stroke thalamic pain

Interventions

Control group:receive oral administration of wishful-treasure pill simulant 5 pills per dose twice daily

Experimental group:receive oral administration of wishful-treasure pills 5 pills per dose twice daily

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meeting the diagnostic criteria for post-stroke thalamic pain according to Western medicine standards; (2) Aged between 18-80 years regardless of gender; (3) First-time stroke patients or those with multiple stroke histories but with modified Rankin Scale (mRS) score of 0 prior to the current episode; (4) History of post-stroke thalamic pain =3 months; (5) Visual Analog Scale (VAS) score =4 for pain or sensory impairment; (6) Capable of cooperating with physical examinations laboratory tests and scale assessments; (7) Participants provide informed consent and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients with comorbid conditions confirmed by examinations including traumatic brain injury brain tumors or cerebral parasitic diseases; (2) Acute stroke patients (disease duration =14 days); (3) Patients with pre-existing severe diseases of the digestive respiratory urinary hematologic or reproductive systems deemed ineligible by investigators; (4) Patients with severe hepatic/renal dysfunction or abnormal liver/kidney function tests (ALT/AST =1.5×ULN Cr >ULN); (5) Patients with pain attributable to other causes; (6) Patients requiring concomitant medications with similar therapeutic effects to the investigational drug; (7) Patients requiring regular opioid medication; (8) Patients with comorbidities/complications affecting evaluations (e.g. epilepsy cognitive impairment consciousness disorders severe anxiety/depression or significant physical disabilities); (9) Patients with known or suspected hypersensitivity to investigational drug components or simulants; (10) Patients with suspected or confirmed history of alcohol abuse or substance misuse; (11) Pregnant/lactating women or those with near-term pregnancy plans; (12) Participation in other clinical trials within 3 months prior to enrollment.

Design outcomes

Primary

Measure	Time frame
Visual Analog Scale (VAS) scores;	—

Secondary

Measure	Time frame
Hamilton Depression Rating Scale (HAMD);National Institutes of Health Stroke Scale (NIHSS);Pittsburgh Sleep Quality Index (PSQI);Hamilton Anxiety Rating Scale (HAMA);Visual Analog Scale (VAS) scores;Stroke Syndrome Element Diagnostic Scale;Short Form-36 Health Survey (SF-36);	—

Countries

China

Contacts

Public ContactLi Zhou

Dongzhimen Hospital Beijing University of Chinese Medicine

Zhouljk7211@163.com+86 133 6695 9763

Outcome results

None listed

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