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Completed

NCT Number: NCT05234814

Fire Dragon Pot Moxibustion

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Perimenopause Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Third Affiliated Hospital of Anhui Medical University (The first people ' s Hospital of Hefei)

Hefei, Anhui, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional Chinese Medicine auricular acupuncture point buried seeds therapy plus the fire dragon pot moxibustion therapy.

Other

Fire dragon pot moxibustion treatment The main acupuncture points are as follows: Fengchi, Jianjin, Dazhui, Feiyu, Xinyu, Ganyu, Piyu, Shenyu, etc (all acupuncture points are positioned according to the national standard: GB/T12346-2006).

Ear acupuncture seed burial method According to "Ear Acupuncture Therapy" [6], the main acupuncture points were Shenmen, subcortical, sympathetic, endocrine, kidney, heart, liver and spleen (all acupuncture points were positioned according to the national standard: GB/T12346-2006).

Traditional Chinese Medicine auricular acupuncture point buried seeds therapy

Other

Ear acupuncture seed burial method According to "Ear Acupuncture Therapy" [6], the main acupuncture points were Shenmen, subcortical, sympathetic, endocrine, kidney, heart, liver and spleen (all acupuncture points were positioned according to the national standard: GB/T12346-2006).

Primary outcomes

  1. The score of Pittsburgh Sleepiness Quantifier Inventory

    Time frame: 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 outcomes

  1. Adverse reactions

    Time frame: one month

    Observe whether erythema, blisters, allergic and other adverse reactions are appearing

Sponsors and collaborators

Lead sponsor

Weihua Yu

Other

Registry information

Official study title

Clinical Study of Auricular Point Seed Burying Combined With Fire Dragon Pot Moxibustion in Perimenopausal Women With Insomnia

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2022
Registry last updated
Feb 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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