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Clinical Effectiveness of Eight-Section Vajra Exercise Intervention in Postmenopausal Women with Insomnia

Clinical Effectiveness of Eight-Section Vajra Exercise Intervention in Postmenopausal Women with Insomnia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078176
Enrollment
Unknown
Registered
2023-11-30
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

Insomnia disorder

Interventions

Eight-Section Vajra Exercise group:Practice Eight-Section Vajra Exercise for 12 weeks
Eight-Section Vajra Exercise combined medication group:Combined practice of the Eight-part Vajra Exercise for 12 weeks alongside the intake of psychotropic medications (benzodiazepines, novel benzodia

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Fulfills the criteria for insomnia diagnosis and standards for natural postmenopausal status; (2) Aged between 40 and 70 years; (3) Pittsburgh Sleep Quality Index (PSQI) total score > 7; (4) Willingly participates in this study and can cooperate in completing various scale evaluations during and throughout the treatment process; (5) Obtain Informed Consent

Exclusion criteria

Exclusion criteria: (1) Unable to learn and master the Eight-part Vajra Exercise (more than 3 times a week, each session >30 minutes), or any severe physical condition that prevents participation in training; (2) Insomnia caused by other diseases (e.g., cancer, autoimmune diseases) or medication-induced (e.g., long-term corticosteroid use, cancer chemotherapy), chronic pain sufferers; (3) Patients with severe sleep apnea, Restless Legs Syndrome, personal or family (first-degree relatives) history of abnormal sleep; (4) Coexisting serious conditions related to the cardiovascular, pulmonary, liver, renal, and endocrine systems; (5) Unstable vital signs; (6) Individuals who need to sleep accompanied by children; (7) Patients diagnosed with severe anxiety based on the Generalized Anxiety Disorder scale (GAD-7) (total score =15); (8) Patients diagnosed with moderate to severe depression based on the Patient Health Questionnaire (PHQ-9) (total score =15); (9) Individuals who have participated in or are currently participating in other clinical trials within the last month; (10) Patients already practicing the Eight-part Vajra Exercise; (11) Patients diagnosed with severe insomnia according to the Insomnia Severity Index (ISI) (total score =22); (12) Exclusion of those using melatonin receptor agonists: agomelatine, ramelteon, tasimelteon; atypical antipsychotic drugs: olanzapine, quetiapine; other antihistamines: diphenhydramine, chlorpheniramine, promethazine, etc.; melatonin and valerian root.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index;

Secondary

MeasureTime frame
The Insomnia Severity Index;Traditional Chinese Medicine Quality of Life Scale for Insomnia;Actigraph;sleep diary;Use of Psychotropic Drugs;Fatigue Severity Scale ;Training Situation: Duration and frequency of daily training; functional Magnetic Resonance Imaging;Nail fold microcirculation detection;

Countries

China

Contacts

Public ContactZhimin Yang

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.

yangyovip@126.com+86 138 2229 6366

Outcome results

None listed

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