Fire Dragon Pot Moxibustion

• ClinicalTrials.gov Identifier: NCT05234814
• Recruitment Status: Completed
• First Posted: February 10, 2022
• Last Update Posted: February 10, 2022
• Sponsor: Weihua Yu
• Information provided by (Responsible Party): Weihua Yu, Anhui Medical University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Insomnia; Perimenopause	Other: Traditional Chinese Medicine auricular acupuncture point buried seeds therapy plus the fire dragon pot moxibustion therapy.; Other: Traditional Chinese Medicine auricular acupuncture point buried seeds therapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Clinical Study of Auricular Point Seed Burying Combined With Fire Dragon Pot Moxibustion in Perimenopausal Women With Insomnia
• Actual Study Start Date: January 1, 2020
• Actual Primary Completion Date: October 30, 2020
• Actual Study Completion Date: October 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Control group; The control group was given the Traditional Chinese Medicine auricular acupuncture point buried seeds therapy.	Other: Traditional Chinese Medicine auricular acupuncture point buried seeds therapy; 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).
Experimental: Observation group; The observation group was given the auricular acupuncture point buried seeds therapy plus the fire dragon pot moxibustion therapy.	Other: Traditional Chinese Medicine auricular acupuncture point buried seeds therapy plus the fire dragon pot moxibustion therapy.; 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).

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Adverse reactions [ Time Frame: one month ]
   Observe whether erythema, blisters, allergic and other adverse reactions are appearing

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

China, Anhui

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

Hefei, Anhui, China

Sponsors and Collaborators

Weihua Yu

Investigators

• Principal Investigator: Weihua Yu, Dr.; The Third Affiliated Hospital of Anhui Medical University

More Information

• Responsible Party: Weihua Yu, Director of nursing department, Anhui Medical University
• ClinicalTrials.gov Identifier: NCT05234814
• Other Study ID Numbers: 2019-041-01
• First Posted: February 10, 2022
• Last Update Posted: February 10, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: The data is available upon reasonable request

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

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