Fire Dragon Pot Moxibustion

Not Applicable

Completed

• Conditions: Insomnia; Perimenopause
• Interventions: Other: Traditional Chinese Medicine auricular acupuncture point buried seeds therapy; Other: Traditional Chinese Medicine auricular acupuncture point buried seeds therapy plus the fire dragon pot moxibustion therapy.

• Registration Number: NCT05234814
• Lead Sponsor: Weihua Yu

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.

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2020-10-30
• Study Completion: 2020-10-30
• Study First Submitted: 2022-01-28
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-08
• Last Update Submitted: 2022-02-08
• Study First Posted: 2022-02-10
• Last Update Posted: 2022-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Traditional Chinese Medicine auricular acupuncture point buried seeds therapy	The control group was given the Traditional Chinese Medicine auricular acupuncture point buried seeds therapy.
Observation group	Traditional Chinese Medicine auricular acupuncture point buried seeds therapy plus the fire dragon pot moxibustion therapy.	The observation group was given the auricular acupuncture point buried seeds therapy plus the fire dragon pot moxibustion therapy.

Primary Outcome Measures

Name	Time	Method
The score of Pittsburgh Sleepiness Quantifier Inventory	one month	The score of Pittsburgh Sleepiness Quantifier Inventory (PSQI) was compared between the two groups of patients before and after the intervention (For details, please refer to the literature: The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research). A PSQI score \<7 is considered good sleep quantity and ≥7 is poor sleep quality, and the higher the patient score, the worse the sleep quality.

Secondary Outcome Measures

Name	Time	Method
Adverse reactions	one month	Observe whether erythema, blisters, allergic and other adverse reactions are appearing

Trial Locations

Locations (1)

The Third Affiliated Hospital of Anhui Medical University (The first people ' s Hospital of Hefei); 🇨🇳 Hefei, Anhui, China