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

Tracking Information

• First Submitted Date: January 28, 2022
• First Posted Date: February 10, 2022
• Last Update Posted Date: February 10, 2022
• Actual Study Start Date: January 1, 2020
• Actual Primary Completion Date: October 30, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 8, 2022)

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.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 8, 2022)

Adverse reactions [ Time Frame: one month ]

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Insomnia
• Perimenopause

Intervention

• 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).

• 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).

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 8, 2022): 70
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 30, 2020
• Actual Primary Completion Date: October 30, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05234814
• Other Study ID Numbers: 2019-041-01
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

IPD Sharing Statement

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

• Current Responsible Party: Weihua Yu, Anhui Medical University
• Original Responsible Party: Same as current
• Current Study Sponsor: Weihua Yu
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Anhui Medical University
• Verification Date: February 2022