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Observation on the therapeutic effect of umbilical moxibustion on insufficient menstruation of spleen kidney yang deficiency type based on ear acupoint application pressure

Registration number：

ITMCTR2024000517

Date of Last Refreshed on：

2024-10-09

Date of Registration：

2024-10-09

Registration Status：

Retrospective registration

Public title：

Observation on the therapeutic effect of umbilical moxibustion on insufficient menstruation of spleen kidney yang deficiency type based on ear acupoint application pressure

English Acronym：

Scientific title：

Observation on the therapeutic effect of umbilical moxibustion on insufficient menstruation of spleen kidney yang deficiency type based on ear acupoint application pressure

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Junrui Ma

Study leader：

Junrui Ma

Applicant telephone：

15912503868

Study leader's telephone：

15912503868

Applicant Fax：

Study leader's fax：

Applicant E-mail：

1134666034@qq.com

Study leader's E-mail：

1134666034@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 130 Wuyi Road Wuhua District Kunming City Yunnan Province

Study leader's address：

No. 130 Wuyi Road Wuhua District Kunming City Yunnan Province

Applicant postcode：

650000

Study leader's postcode：

650000

Applicant's institution：

Yunnan University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

XW2023-031

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of the First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

Date of approved by ethic committee：

2023/12/8 0:00:00

Contact Name of the ethic committee：

Jun Ma

Contact Address of the ethic committee：

No. 48 Xiyuan Road Xishan District Kunming City Yunnan Province

Contact phone of the ethic committee：

087163635609

Contact email of the ethic committee：

ynszyyylunli@126.com

Primary sponsor：

Yunnan Provincial Traditional Chinese Medicine Hospital

Primary sponsor's address：

No. 120 Wuyi Road Wuhua District Kunming City Yunnan Province

Secondary sponsor：

Country：

China

Province：

Yunnan

City：

Kunming

Institution
hospital：

Yunnan University of Traditional Chinese Medicine

Address：

No. 1076 Yuhua Road Chenggong District Kunming City

Source(s) of funding：

raise independently

N91.400

Target disease：

hypomenorrhea

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

Observation of the efficacy and safety of navel moxibustion in the treatment of spleen kidney yang deficiency type of oligomenorrhea based on ear point application pressure. Combining navel moxibustion with ear point application pressure alone to observe the efficacy of the combined therapy in order to shorten the treatment period improve patients' menstrual flow traditional Chinese medicine syndrome anxiety and depression and provide a better treatment plan for clinical treatment of spleen kidney yang deficiency type of oligomenorrhea.

Description for medicine or protocol of treatment in detail：

2.1 Select 94 patients aged 18-40 with spleen kidney yang deficiency type of oligomenorrhea who met the inclusion and exclusion criteria and were treated at the Traditional Chinese Medicine Characteristic Nursing Clinic of Yunnan Provincial Hospital of Traditional Chinese Medicine from December 2023 to September 2024. 2.2 According to the random number table method patients were randomly divided into a control group (n=47) and an experimental group (n=47) and each group received routine outpatient care. Control group: Ear acupressure treatment was performed on the basis of routine nursing care; Experimental group: Umbilical moxibustion treatment was performed on the basis of the control group. Among them the selected acupoints for ear acupressure are as follows: main acupoints: uterus ovary pituitary gland kidney liver thalamus; Matching acupoints: sympathetic cardiovascular subcortical and gonadotropin points. The navel moxibustion group selects the Shenque acupoint. 2.3 The treatment duration is 8 weeks once a week with 8 sessions per course of treatment and 1 course of treatment. Compare the menstrual flow improvement of traditional Chinese medicine syndromes and anxiety and depression before and after treatment.

Inclusion criteria

① Meets the diagnostic criteria of traditional Chinese and Western medicine for oligomenorrhea; ② Meets the diagnostic criteria for oligomenorrhea of spleen kidney yang deficiency type in the "Diagnostic and Therapeutic Efficacy Standards for Traditional Chinese Medicine Diseases"; ③ Age range: 18-40 years old; ④ The patient voluntarily participated in this study and signed an informed consent form; ⑤ The patient has not used any relevant medication or non medication to treat oligomenorrhea in the past three months or during the research process; ⑥ Exclude organic lesions through examination. Note: All projects must meet the requirements.

Exclusion criteria：

① Pelvic tuberculosis intrauterine adhesions hyperprolactinemia severe thyroid dysfunction hormone dependent tumors etc; ② Patients with severe organic diseases liver and kidney dysfunction serious cardiovascular and cerebrovascular diseases mental illness bilateral oophorectomy or coagulation dysfunction; ③ Those who are unable or unwilling to cooperate; ④ Known to be allergic to ear acupressure stickers alcohol and moxibustion ingredients; ⑤ Patients with umbilical skin damage eczema infections etc. Note: Any non-compliance with the above criteria will be excluded.

Study execute time：

From 2023-12-08

To      2024-09-20

Recruiting time：

From 2023-12-08

To      2024-09-20

Interventions：

47

Group：

Control group

Sample size：

Intervention：

Ear acupressure

Intervention code：

47

Group：

Experimental group

Sample size：

Intervention：

Ear acupressure+navel moxibustion

Intervention code：

Total sample size ： 94

Countries of recruitment
and research settings：

Country：

China

Province：

Yunnan

City：

Kunming

Institution/hospital：

Yunnan Provincial Traditional Chinese Medicine Hospital

Level of the institution：

PProvincial level

Outcomes：

Outcome：

Menstrual cycle

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Anxiety and depression

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

TCM syndrome

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Completed

18
Min age years
40
Max age years

Recruiting status：

Participant age：

Gender：

Female

Randomization Procedure (please state who generates the random number sequence and by what method)：

94 selected cases were randomly divided into a control group and an experimental group in a 1:1 ratio using a computer-generated random number table. The specific operation is to use the random number series generated by SPSS 26.0 software and then correspond the numbers 1-94 with the generated 94 random number sequences one by one

Blinding：

IPD sharing：

No

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Not yet organized

Data Managemen Committee：

No

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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