Clinical trial NCT05234814: Fire Dragon Pot Moxibustion
Official title: Clinical Study of Auricular Point Seed Burying Combined With Fire Dragon Pot Moxibustion in Perimenopausal Women With Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Perimenopause
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants with perimenopausal insomnia were randomly divided into a control group and an observation group. Participants in the control group were treated with the traditional Chinese medicine nursing intervention of burying seeds at auricular points. And participants in the observation group were additionally treated with fire dragon pot moxibustion.
Primary purpose: TREATMENT

Brief summary: Insomnia in perimenopausal women is normal. Studies have shown that insomnia occurs in 75-81% of perimenopausal women and is 2.4 times more common than in premenopausal participants. Western medicine often uses sedative sleeping drugs in the treatment of insomnia in perimenopausal women, which have better effects but have more side effects, and whether they are suitable for long-term application is still controversial. Non-pharmacological traditional therapies in Traditional Chinese Medicine have achieved significant clinical efficacy in the treatment of perimenopausal insomnia patients in recent years. This study aims to explore the efficacy of auricular point seed burying combined with fire dragon pot moxibustion in the treatment of the insomnia symptoms of perimenopausal women.

Detailed description: Female menopausal participants often experience physical and psychological symptoms such as anxiety, depression and sleep disturbances due to the weakening of the ovaries and hormonal changes in the body, with insomnia being the most typical symptom. Studies have shown that insomnia occurs in 75-81% of perimenopausal women and is 2.4 times more common than in premenopausal participants. The main symptoms are difficulty falling asleep, early awakening and easy waking, which may be accompanied by anxiety, irritability and sweating. Long-term insomnia will lead to impairment of multi-system function and endanger the physical and mental health of perimenopausal women. The treatment of insomnia during menopause in Western medicine is mainly based on pharmacological treatment, but it is controversial whether it is suitable for long-term clinical application due to drug dependency and other side effects. Non-pharmacological traditional therapy in Traditional Chinese Medicine is more acceptable to participants because of its efficacy, non-chemical and non-toxic side effects. Furthermore, it has been used in the clinical application of insomnia in perimenopausal participants with good efficacy in recent years. In this study, we used auricular seeds burying combined with fire dragon pot moxibustion as an appropriate Chinese medicine technique to treat perimenopausal women with insomnia, hoping to improve the life quality of perimenopausal women with insomnia.

Eligibility criteria: Inclusion Criteria:

* All participants met the diagnosis of perimenopausal insomnia as described in the Chinese Guidelines for the Diagnosis and Treatment of Adult Insomnia (2017 Edition).
* Pittsburgh Sleep Quality Index (PSQI) \>7.
* Insomnia at least 3 times per week and lasting for more than 1 month.
* Onset around menopause with menstrual disorders.
* No contraindications to auricular seed burial and fire dragon pot moxibustion treatment
* Informed consent.

Exclusion Criteria:

* Those with a duration of less than 1 week or those who have received other relevant treatment within the last month that affects the observation of efficacy
* Secondary insomnia due to physical illness or psychological disorders.
* Participants with severe co-morbidities and psychiatric disorders.
* Those who refuse to cooperate with treatment.
* Those who use other methods of treatment during the treatment period, which affects the judgment of efficacy.

Primary outcomes:
measure: The score of Pittsburgh Sleepiness Quantifier Inventory
timeFrame: one month
Secondary outcomes:
measure: Adverse reactions
timeFrame: one month
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Third Affiliated Hospital of Anhui Medical University (The first people ' s Hospital of Hefei)
state: Anhui
Study officials:
affiliation: The Third Affiliated Hospital of Anhui Medical University
name: Weihua Yu, Dr.
role: PRINCIPAL_INVESTIGATOR
References: