The Study on the Evaluation of Acupuncture Therapy on Primary Insomnia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe Third Affiliated hospital of Zhejiang Chinese Medical University

About this trial

Through the recruition of outpatients who clinically meet the diagnostic criteria and inclusion criteria of PI, the acupuncture group adopts Tiaoshen acupuncture, and the placebo acupuncture group adopts non-insertive acupuncture supported by the Park device, and the Pittsburgh Sleep Quality Index (PSQI) is used as the main index to evaluate the patients through the scale; subjective indicators like Chalder 14-item fatigue scale, Epworth sleepiness rating, self-rating anxiety scale (SAS), self-rating depression scale (SDS) and objective indicators like polysomnography (PSG), heart rate variability (HRV) is regarded as a secondary index, and then evaluate the clinical efficacy of Tiaoshen acupuncture on PI and explore its mechanism.

Eligibility criteria

Qualifiers

Conforming to the diagnostic criteria of traditional Chinese and Western medicine for chronic insomnia;

Age range: 18-70 years old;

PSQI score>7 points; SAS score > 50 or SDS score > 53;

No communication and cognitive impairment;

Disqualifiers

Those who do not meet the inclusion criteria;

Persons with a history of severe mental illness, severe head injury, and significant disturbance of consciousness;

Those with severe liver and renal insufficiency and bleeding tendencies;

Alcoholism (liquor ≥ 100ml/day), smoking (≥ 15 cigarettes/day), drug abuse or taking psychotropic drugs;

Trial design

Treatments tested in this trial

  • the acupuncture group
  • the placebo acupuncture group

Treatment groups

84 Participants
are divided into 2 treatment groups