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To study the mechanism of Peiyuan Ningshen Ointment in improving insomnia of Qi deficiency based on the gut-brain axis of bacteria

To study the mechanism of Peiyuan Ningshen Ointment in improving insomnia of Qi deficiency based on the gut-brain axis of bacteria

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087247
Enrollment
Unknown
Registered
2024-07-23
Start date
2024-04-02
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

insomnia

Interventions

Sponsors

Guangdong Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years; 2. According to the International Classification of Sleep Disorders (ICSD3), meet the diagnostic criteria of ICSD3: (1) Having one or more of the following symptoms: difficulty falling asleep, difficulty maintaining sleep, waking up early and easily waking up, inability to fall asleep on time, difficulty falling asleep on time, difficulty falling asleep without parent or caregiver interference; (2) Symptoms related to insomnia disorder: fatigue and discomfort, impaired concentration and memory, affected social functions, family, work, etc., emotional disturbance or irritability, daytime sleepiness, behavioral problems (impulsivity, aggression), no Motivation, error prone, worry about sleep; (3) Complications cannot be explained by insufficient sleep opportunities and sleep environment; (4) Sleep disturbances and complications at least 3 times per week, currently occurring for at least 3 months; 3. 7 points < PSQI score < 15 points; 4.In line with qi deficiency constitution 5. Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Insomnia is caused by other types of sleep disorders (such as sleep apnea syndrome, restless legs syndrome, etc.) rise; 2. Combined with acute and chronic diseases that may affect sleep and immunity (such as heart, cerebrovascular diseases, inflammatory diseases, tumors, acute and chronic infections); 3. Patients with moderate or severe depression diagnosed according to the Patient Depression Self-Assessment Tool (PHQ-9) (total score >= 10); 4. Diagnose patients with moderate or severe anxiety according to the Generalized Anxiety Scale (GAD-7) (total score >= 10); 5. According to the STOP-Bang questionnaire, those with a score of 3 or above are considered to be at high risk of OSAHS; 6. Pregnant and lactating women, menstrual women need to be tested again when they are not menstrual; 7. Those who have taken any anti-inflammatory drugs, antidepressant drugs, antipsychotic drugs, sedative and sleeping drugs in the past 1 week.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index scale;5-HT;GABA;

Secondary

MeasureTime frame
Self-rating depression Scale;7-tiem Generalized Anxiety Disorder Scale, GAD-7;TCM Life Quality Scale;interleukin-6;tumor necrosis factor-alpha;TCM Life Quality Scale;

Countries

China

Contacts

Public Contactsunchen

Guangdong Hospital of Traditional Chinese Medicine

sunchen87319@163.com+86 138 2513 0019

Outcome results

None listed

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