Fire Dragon Pot Moxibustion
Primary Purpose
Insomnia, Perimenopause
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Traditional Chinese Medicine auricular acupuncture point buried seeds therapy plus the fire dragon pot moxibustion therapy.
Traditional Chinese Medicine auricular acupuncture point buried seeds therapy
Sponsored by
About this trial
This is an interventional treatment trial for 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.
Sites / Locations
- The Third Affiliated Hospital of Anhui Medical University (The first people ' s Hospital of Hefei)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Observation group
Arm Description
The control group was given the Traditional Chinese Medicine auricular acupuncture point buried seeds therapy.
The observation group was given the auricular acupuncture point buried seeds therapy plus the fire dragon pot moxibustion therapy.
Outcomes
Primary Outcome Measures
The score of Pittsburgh Sleepiness Quantifier Inventory
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
Adverse reactions
Observe whether erythema, blisters, allergic and other adverse reactions are appearing
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05234814
Brief Title
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
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
October 30, 2020 (Actual)
Study Completion Date
October 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Weihua Yu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Perimenopause
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The control group was given the Traditional Chinese Medicine auricular acupuncture point buried seeds therapy.
Arm Title
Observation group
Arm Type
Experimental
Arm Description
The observation group was given the auricular acupuncture point buried seeds therapy plus the fire dragon pot moxibustion therapy.
Intervention Type
Other
Intervention Name(s)
Traditional Chinese Medicine auricular acupuncture point buried seeds therapy plus the fire dragon pot moxibustion therapy.
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Traditional Chinese Medicine auricular acupuncture point buried seeds therapy
Intervention Description
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 Outcome Measure Information:
Title
The score of Pittsburgh Sleepiness Quantifier Inventory
Description
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.
Time Frame
one month
Secondary Outcome Measure Information:
Title
Adverse reactions
Description
Observe whether erythema, blisters, allergic and other adverse reactions are appearing
Time Frame
one month
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weihua Yu, Dr.
Organizational Affiliation
The Third Affiliated Hospital of Anhui Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third Affiliated Hospital of Anhui Medical University (The first people ' s Hospital of Hefei)
City
Hefei
State/Province
Anhui
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data is available upon reasonable request
Learn more about this trial
Fire Dragon Pot Moxibustion
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