Study for the effect of SuGanNingShen Recipe on the clinical effectiveness and intestinal flora of insomnia patients.

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300073755

Enrollment

Unknown

Registered

2023-07-20

Start date

2023-07-17

Completion date

Unknown

Last updated

2023-07-25

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

Conditions

Insomnia

Interventions

Test group:SuGanNingShen Recipe + Western medicine placebo

Positive control group:Esazolam + Chinese medicine placebo

Waiting group:Chinese medicine placebo+Western medicine placebo

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Aged 18-65 years old. 2. Those who are informed about this research, volunteer to take the test and sign the informed consent. 3.Satisfy the diagnostic criteria of traditional Chinese medicine, which the TCM types belong to liver stagnation and spleen deficiency syndrome. 4.Satisfy the ICSD-3 criteria for primary insomnia. 5.Those who have a Pittsburgh Sleep Quality Index (PSQI)score of more than 6. 6.Those who have no special dietary habits or are not treated with antibiotics, antifungals, anti-inflammatory drugs for at least 6 months. 7.Those who are willing to provide blood, urine and stool specimens

Exclusion criteria

Exclusion criteria: 1.Patients with severe psychiatric such as generalised anxiety disorder, major depression 2.Participants taking other medications that have central nervous system effects or affect performance and cannot experience further discontinuation. 3. Combined with severe diseases such as cardiovascular, brain, kidney, blood system and endocrine metabolism. 4.Patients with leep apnea syndrome, periodic limb movement disorder, rapid eye movement (REM) sleep disorder, restless legs syndrome, narcolepsy and other sleep disroders. 5. Pregnant women and Caregivers. 6.Those who are no substance-abuser (psychoactive substances or sleep medications) 7.Those who fail to perform detections for various reasons.

Design outcomes

Primary

Measure	Time frame
Gut Microbiota;mRNA;	—

Secondary

Measure	Time frame
TCM Syndrome Scale;pSQI Sleep Scale;HAMA Anxiety Scale;Insomnia Scale;	—

Countries

China

Contacts

Public ContactMing Hong

The First Affiliated Hospital of Guangdong Pharmaceutical University

7819466@qq.com+86 137 1111 2672

Outcome results

None listed

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