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Study on the effect mechanism of Yangyin Shugan formula combined with frontal (spinal) acupuncture in the treatment of climacteric depression based on brain intestinal axis pathway

Study on the effect mechanism of Yangyin Shugan formula combined with frontal (spinal) acupuncture in the treatment of climacteric depression based on brain intestinal axis pathway

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060333
Enrollment
Unknown
Registered
2022-05-28
Start date
2022-05-16
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Climacteric depression

Interventions

Group 1:YYSG granule + Frontal Acupuncture
Group 2:YYSG granule + Sham Frontal Acupuncture
Group 3:Frontal Acupuncture + YYSG placebo granules
Group 4:YYSG placebo granule + Sham Frontal Acupuncture

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. 40 years old 10 U/L, serum E2 levels decreased; 3. Depression or depression, sighing, easy to pessimistic, accompanied by upset, sometimes flushing, hot flashes, backache, etc.; 4. Insomnia, dreaminess, mainly manifested as difficulty in falling asleep at night, not deep sleep, early awakening, and difficulty falling back asleep after waking up; 5. The scores of 17 items of Hamilton Depression Scale (HAMD) are all >= 8 points; or the scores of SAS scale and SDS scale are >= 62 points; 6. For menstrual disorders, the thickness range of the subject's B-ultrasound endometrium is 7 mm - 10 mm (including the boundary value); 7. Dark tongue, thin yellow or white fur, stringy and weak pulse.

Exclusion criteria

Exclusion criteria: 1. Used sex hormone therapy, selective estrogen receptor modulators, or aromatase inhibitors, soybean extracts in the past 3 months; 2. Those who have a history of habitual use of antibiotics or have used antibiotics, probiotics, prebiotics, micro-ecological live bacteria preparations; laxatives or other drugs that affect gastrointestinal function in the past 1 month; 3. Participated in phase III-IV clinical research in the past 3 months; 4. Combined with malignant tumors of the breast, digestive tract, and reproductive tract; 5. Pregnant or lactating women; 6. Combined with severe liver, kidney, heart, and brain diseases; gastrointestinal diseases, diabetes, obesity, etc.; 7. Combining other genetic mental diseases such as personal history/family history of mental diseases; 8. Those with damaged skin at the treatment site; 9. Those who are unwilling to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Greene scale;Self-rating Anxiety Scale (SAS);Self-rating Depression Scale (SDS);Hamilton Anxiety Scale, HAMA Scale;Hamilton Depression Scale, HAMD;

Secondary

MeasureTime frame
Serum sex hormone level;Brain fMRI;Detection of intestinal flora;

Countries

China

Contacts

Public ContactCao Xiaojing

Guangdong Provincial Hospital of Chinese Medicine

xjcao@gzucm.edu.cn+86 20 81887233

Outcome results

None listed

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