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Development and Clinical Study of a Ceramic Bowl Navel Moxibustion Treatment System for Systemic Lupus Erythematosus-Related Insomnia Based on the Theory of "Restlessness of the Spirit Leads to Insomnia"

Development and Clinical Study of a Ceramic Bowl Navel Moxibustion Treatment System for Systemic Lupus Erythematosus-Related Insomnia Based on the Theory of "Restlessness of the Spirit Leads to Insomnia"

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000133
Enrollment
Unknown
Registered
2026-01-24
Start date
2025-09-16
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Systemic Lupus Erythematosus

Interventions

Control Group:Routine care
Treatment group:Routine care + ceramic moxibustion treatment of the navel.

Sponsors

Henan University of Traditional Chinese Medicine First Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meets the diagnostic criteria for Systemic Lupus Erythematosus (SLE) and insomnia; (2) Has a Pittsburgh Sleep Quality Index (PSQI) score > 7; (3) Aged between 18 and 80 years, with no restriction on gender; (4) Has provided informed consent and voluntarily agreed to participate in the research project; (5) Is conscious and oriented, with the ability to understand and express oneself.

Exclusion criteria

Exclusion criteria: (1) Patients with severe heart, liver, or kidney dysfunction; (2) Patients with skin lesions, ulceration, inflammation, or sensory impairment around the Shenque (navel) acupoint; (3) Patients allergic to the herbal powder used in this study or those with allergic constitutions; (4) Patients currently participating in other non-drug-related research; (5) Pregnant and breastfeeding women, and patients with other major diseases; (6) Patients with poor compliance.

Design outcomes

Primary

MeasureTime frame
Overall Efficiency;

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index Scale;Anxiety Self-Rating Scale;Traditional Chinese Medicine Syndrome Scoring;Adverse reaction incidence rate;

Countries

China

Contacts

Public ContactWang Dezhen

Henan University of Traditional Chinese Medicine First Affiliated Hospital

w1dezhen@163.com15038133182

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026