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Clinical study on the efficacy of different diameter needles in the treatment of primary insomnia

Clinical study on the efficacy of different diameter needles in the treatment of primary insomnia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069887
Enrollment
Unknown
Registered
2023-03-28
Start date
2023-03-28
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

primary insomnia

Interventions

Experimental Group:0.40×25mm acupuncture needle
Control Group:0.25×25mm acupuncture needle

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: (a) age of 18-50 years old, male or female; (b) patients with insomnia according to DSM-V criteria; (c)PSQI score greater than 5 points; (d) have not used any medications or treatments that affect sleep within 2 weeks before the visit; (e) no acupuncture related to the treatment of primary insomnia within 1 week before the visit; (f) High school education or above; (g) written informed consent was obtained.

Exclusion criteria

Exclusion criteria: (a)SAS score ?50; (b)SDS?53; (c) secondary insomnia; (d) combined with heart, liver, kidney, lung, brain and other serious organic diseases; (e) pregnant or lactating women, or those who intend to become pregnant; (f) with other types of sleep disorders or other serious mental disorders; (g) Severe chronic insomnia: sleepers and difficulty maintaining normal work for more than 6 months; (h) patients had participated in other clinical trials within the past 3 months; (i) alcohol and/or psychoactive substance, substance abusers and dependants (including hypnotics); (j) Failure to cooperate with treatment; (k) patients with coagulopathy; (l) patients with skin lesions, infections, ulcers, or skin tumors at the treatment site.

Design outcomes

Primary

MeasureTime frame
Pittsburgh sleep quality index,PSQI;

Secondary

MeasureTime frame
Insomnia severity index,ISI;Adverse reactions;

Countries

China

Contacts

Public ContactKui Yu

Guangdong Provincial Hospital of Traditional Chinese Medicine

kuiyutcm@gzucm.edu.cn13925052921

Outcome results

None listed

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