Fire Dragon Pot Moxibustion (NCT05234814) | Clinical Trial Compass
CompletedNot Applicable
Fire Dragon Pot Moxibustion
China70 participantsStarted 2020-01-01
Plain-language 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.
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The score of Pittsburgh Sleepiness Quantifier Inventory