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The specific effect of Shugantiaoshen acupuncture therapy on depressive insomnia: a randomized controlled trial

The specific effect of Shugantiaoshen acupuncture therapy on depressive insomnia: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-15007649
Enrollment
Unknown
Registered
2015-09-25
Start date
2015-09-25
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

depressive insomnia

Interventions

acupuncture group:Acupunct on LR3, LI4, HT7, SP6, anmian, DU20, EX-HN3, and needle-embedding therapy on BL18, BL15 or BL44, BL42.
Mental regulation group:Acupunct on HT7, SP6, anmian
and needling embedding therapy on BL18 or BL44.
liver qi regulation group:Acupunct on LR3, LI4, DU20, EX-HN3. And needling embedding therapy on, BL15 or BL42.
placebo Acupuncture group:the same acupunct point with aucpuncture group, but instead of using streitberer placebo needle and embedding needle without sharp head.

Sponsors

Acupuncture & Moxibustion department of Guangdong Provincial Hospital of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-70 years; 2. Fulfilling criteria A and B of the DSM-V diagnosis of primary insomnia; 3. chief complain of insomnia at least 3 nights per week for at least one month; 4. previous diagnosis of depressive disorder based on CCMD and DSM-V, as assessed by a psychiatrist; 5. PSQI score >=15; 6. HAMD score between 20 and 35; 7. Subjects be conscious, educated, well comprehended and high compliance of acupuncture therapy; 8. Without suicidal tendency and dysthymia exacerbation assessing by psychiatrist; 9. not receiving any other acupuncture treatment or clinic trail. 10. Signing the informed consent form. One who meets all the conditions above can be enrolled.

Exclusion criteria

Exclusion criteria: 1. depression and insomnia caused by organic mental disorders,psychoactive substances or drug abusing; 2. cognitive disorder,aphasia, or mental disorders that cannot evaluating the curative effect because of not comprehending of the scale; 3. Suicidal and dysthymia exacerbation risk assessed by psychiatrist; 4. serious illness of heart, liver or kidney or other serious systemic diseases that cannot fulfilling treatment; 5. being pregnant or breast-feeding; 6. diagnosis of coagulopathy; 7. infection or abscess close to the sites of selected acu-points; 8. poor compliance.

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep quality index;Hamilton's Depression Scale;

Secondary

MeasureTime frame
Self-Rating Depression Scale;he MGH Acupuncture Sensation Scale(Chinese version);Insomnia Severity Index;

Countries

China

Contacts

Public ContactWenbin Fu
fuwenbin@139.com+86 13808888626

Outcome results

None listed

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