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Combined therapy of acupuncture and Chinese medicine on menopause mood disorder: a randomized controlled trial

Combined therapy of acupuncture and Chinese medicine on menopause mood disorder: a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-16009132
Enrollment
Unknown
Registered
2016-08-18
Start date
2016-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

menopause mood disorder

Interventions

combied therapy of acupuncture and Chinese medicine:combied therapy of abdominal acupuncture and Chinese medicine
acupuncture group:abdominal acupuncture+placebo of Chinese medicine
Chinese medicine group:Chinese medicine+sham abdominal acupuncture

Sponsors

Guangdong Provincal hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
41 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1. Perimenopause or postmenopause women aged 41-60 years; 2. Follicle stimulating hormone(FSH)>15 IU/L; 3. Participant was diagnosed with depression disorder or anxiety disorder by the Diagnostic and Statistical Manual of Mental Disorders IV(DSMIV), and the symptoms lasting at least 30 days before the screening. Depression or anxiety symptoms appear within 3 years in the climacteric period, or within 5 years of the last menstruation period, and the mood disorder symptoms can not be explained by other physical and mental illness; 4. The Standard score (The Standard score= the total score of the scale×1.25 ) of the Self rating Anxiety Scale(SAS) or Self rating Depression Scale(SDS): patient with moderate depressive: 62=SDS<73 and/or patient with moderate and severe anxiety: SAS=62; 5. No using any of the following treatment for at least 3 months before this study: psychotropic substances,psychological therapy or behavioral therapy, hormone therapy, selective elective estrogen receptor modulators, aromatase inhibitors, soybean extracts or Chinese medicine; 6. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Psychotropic drugs abuse in 12 months before screening; benzodiazepines daily use in the last 3 months; hormone therapy or other therpy for relieving menopause symptoms in the last 3 months; 2. Participate in the I, II period clinical trial within the last 6 months or III, IV period clinical trial within the last 3 months; 3. suicidal tendency; 4. patients with severe depression; 5. Other affective disorder diagnosed by SEM-IV: Schizophrenia disease, mental disorders, dementia, amnestic disorder, anorexia, bulimia, compulsive, anxiety disorders caused by caffeine, significant cognitive impairment and mania, post-traumatic stress disorder, antisocial and borderline, personality disorder, bipolar affective mental division disorder, alcohol or substance abuse or dependence; 6. Known or suspicious cervical cancer or breast cancer; known or suspicious hormone independent cancer history or other cancer history; 7. Uncontrolled and/or diagnosed internal medical conditions that are likely to interfere with or influence study treatment, eg, hepatic or renal dysfunction; thrombophlebitis; thrombotic diseases; Cerebrovascular disease; Myocardial infarction, or ischemic heart disease; gallbladder disease; diabetes mellitus requiring medical treatment; Uncontrolled or untreated hypertension (defined as systolic blood pressure higher than 160 mm Hg and/or diastolic blood pressure higher than 100 mm Hg); thyroid disease(hyperparathyroidism); 8. Allergic to trial medication; 9. Refused to accept acupuncture treatment; 10. Patients with leukemia or thrombocytopenia that with bleeding tendency 11. Severe systemic or abdominal skin diseases.

Design outcomes

Primary

MeasureTime frame
Greene climactic Scale;Self rating Depression Scale;Self rating Anxiety Scale;

Countries

China

Contacts

Public ContactGuangning Nie

Guangdong Provincal hospital of Chinese Medicine

nguangn@163.com+86 13724078380

Outcome results

None listed

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