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Clinical Observation on Ginger-Separated Moxibustion Combined with Acupuncture for Chronic Insomnia Disorder of Heart-Spleen Deficiency Type

Clinical Observation on Ginger-Separated Moxibustion Combined with Acupuncture for Chronic Insomnia Disorder of Heart-Spleen Deficiency Type

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000369
Enrollment
Unknown
Registered
2026-02-13
Start date
2024-02-20
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

Chronic Insomnia Disorder of Heart-Spleen Deficiency Type

Interventions

control group:(1) Cognitive Behavioral Therapy for Insomnia
(2) Acupuncture Treatment
experimental group:(1) Cognitive Behavioral Therapy for Insomnia
(3) Ginger-Separated Moxibustion Therapy

Sponsors

The Affiliated People's Hospital of Fujian University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the Western medicine diagnostic criteria for chronic insomnia disorder; (2) Conform to the traditional Chinese medicine diagnostic criteria for insomnia disease and the heart-spleen deficiency syndrome pattern; (3) Pittsburgh Sleep Quality Index (PSQI) total score: 7-15 points; (4) Aged 18-65 years, gender any; (5) No use of sedative-hypnotic medications or other insomnia-related treatments within 1 week; (6) Voluntarily participate in this study and provide signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with secondary insomnia due to persistent pain, organic diseases, or psychiatric disorders from any cause; (2) Individuals with insomnia attributable to lifestyle factors such as coffee, strong tea, or alcohol consumption; (3) Patients complicated with severe cardiovascular, cerebrovascular, pulmonary, hepatic, renal, or hematopoietic system diseases; (4) Pregnant or lactating women, individuals with needle or moxibustion fainting, those unsuitable for or unwilling to receive acupuncture and moxibustion therapy; (5) Presence of skin damage, infection, or severe dermatological conditions around the umbilicus or at the intended acupuncture sites; (6) Patients with neurological or psychiatric disorders who are unable or unwilling to cooperate; (7) Individuals currently participating in other clinical trials that may interfere with the outcomes of this study, such as trials related to sleep improvement or anxiety and depression.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
Self-rating Anxiety Scale;Self-rating Depression Scale;Fatigue Severity Scale;Traditional Chinese Medicine Syndrome Score Scale;Polysomnography;

Countries

China

Contacts

Public ContactWanqing Lin, Yingling Ye

Fujian University of Traditional Chinese Medicine

yeyingling10@163.com13705976725

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026