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Based on Essence-function Relationship between Yin and Yang to explore the clinical therapeutic mechanism of Trionycis Carapax Partitioned moxibustion combined with auricular point sticking on perimenopausal insomnia patients

Registration number：

ITMCTR2024000621

Date of Last Refreshed on：

2024-10-29

Date of Registration：

2024-10-29

Registration Status：

Prospective registration

Public title：

Based on Essence-function Relationship between Yin and Yang to explore the clinical therapeutic mechanism of Trionycis Carapax Partitioned moxibustion combined with auricular point sticking on perimenopausal insomnia patients

English Acronym：

Scientific title：

Based on Essence-function Relationship between Yin and Yang to explore the clinical therapeutic mechanism of Trionycis Carapax Partitioned moxibustion combined with auricular point sticking on perimenopausal insomnia patients

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Han Sixuan

Study leader：

Han Sixuan

Applicant telephone：

13851572452

Study leader's telephone：

13851572452

Applicant Fax：

Study leader's fax：

Applicant E-mail：

2845395213@qq.com

Study leader's E-mail：

2845395213@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.157 Daming Road Qinhuai District Nanjing City Jiangsu Province China

Study leader's address：

No.157 Daming Road Qinhuai District Nanjing City Jiangsu Province China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Nanjing Hospital of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

KY2024059

Approved file of Ethical Committee：

View

Name of the ethic committee：

Nanjing Hospital of Chinese Medicine Ethics Committee

Date of approved by ethic committee：

2024/8/1 0:00:00

Contact Name of the ethic committee：

Liu zheng

Contact Address of the ethic committee：

No.157 Daming Road Qinhuai District Nanjing City Jiangsu Province China

Contact phone of the ethic committee：

025-52276505

Contact email of the ethic committee：

njszyyll@163.com

Primary sponsor：

Nanjing Hospital of Chinese Medicine

Primary sponsor's address：

No.157 Daming Road Qinhuai District Nanjing City Jiangsu Province China

Secondary sponsor：

Country：

China

Province：

Jiangsu Province

City：

Nanjing City

Institution
hospital：

Nanjing Hospital of Chinese Medicine

Address：

No.157 Daming Road Qinhuai District Nanjing City Jiangsu Province China

Source(s) of funding：

Nanjing Hospital of Chinese Medicine Research Fund

Target disease：

insomnia

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

1. Main objective: To observe and analyze the efficacy and safety of turtle and nail moxibustion combined with auricular point sticking therapy on perimenopausal insomnia patients and to verify its clinical efficacy. 2. Secondary objective: Based on the connotation of yin-yang theory to explore the practical effect and intervention mechanism of the treatment of perimenopausal insomnia under the guidance of yin-yang body moxibustion combined with auricular point sticking in order to provide theoretical basis and develop new ideas and methods for the future clinical promotion of TCM nursing technology characteristics to intervene in perimenopausal insomnia.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1: Perimenopausal insomnia patients with cardio-renal incompatibility in accordance with traditional Chinese and Western medicine diagnosis 2: The subjects were 40-60 years old 3: Pittsburgh Sleep Quality Index (PSQI) score ≥7 4: Primary school education level or above able to understand the content of this study Note: Patients must meet the above five criteria at the same time to enter the study. 5: Volunteer to participate in the study and sign the informed consent

Exclusion criteria：

1: Pregnant and lactating women 2: Complicated with serious diseases of important organs suffering from malignant tumors or organic diseases such as heart brain lung liver kidney and other parts of the primary disease or infectious diseases of the whole body 3: People with mental disorders or cognitive understanding or expressive disabilities 4: Patients with internal genital organ resection and congenital defect of ovarian function 5: People who have used hormone replacement therapy or sleep medication in the last 3 months 6: Patients with severe allergies severe asthma skin collapse or bleeding disorders 7: Unable or unwilling to cooperate 8: Had participated in other clinical trials within 4 weeks prior to the start of this study Note: Patients who meet any of the above criteria will not be enrolled in this study.

Study execute time：

From 2024-11-15

To      2026-04-14

Recruiting time：

From 2024-11-15

To      2026-04-14

Interventions：

33

Group：

Control group (auricular point sticking group)

Sample size：

Intervention：

auricular point sticking therapy

Intervention code：

33

Group：

test group 1 (Trionycis Carapax Partitioned moxibustion group)

Sample size：

Intervention：

Trionycis Carapax Partitioned moxibustion therapy

Intervention code：

33

Group：

test group 2 (Trionycis Carapax Partitioned moxibustion combined with auricular point sticking group)

Sample size：

Intervention：

Trionycis Carapax Partitioned moxibustion combined with auricular point sticking therapy

Intervention code：

Total sample size ： 99

Countries of recruitment
and research settings：

Country：

China

Province：

Jiangsu Province

City：

Nanjing City

Institution/hospital：

Nanjing Hospital of Chinese Medicine

Level of the institution：

city level

Outcomes：

Outcome：

Vital sign index

Type：

Adverse events

Measure time point of outcome：

Before the first treatment intervention 、after the first course and the second course of treatment

Measure method：

The vital signs index were measured by body temperature、 blood pressure、 pulse and respiration.

Outcome：

Adverse reaction monitoring

Type：

Adverse events

Measure time point of outcome：

Each time an operational intervention is performed

Measure method：

Observe whether there are any accidents such as scalding dizzy moxibustion skin damage pain and bleeding during the process of nail moxibustion and ear point sticking and record the adverse reactions of each patient and the treatment methods

Outcome：

Sex hormone test

Type：

Secondary indicator

Measure time point of outcome：

Before the first treatment intervention, and after the second course of treatment

Measure method：

Serum samples were collected and detected by enzyme-linked immunosorbent assay

Outcome：

Objective observation indicators of insomnia symptoms

Type：

Secondary indicator

Measure time point of outcome：

Before the first treatment intervention 、after the first course and the second course of treatment

Measure method：

For the objective indicators of sleep the patient wears Huawei wristband to record the sleep-related data for three consecutive days such as the patient's night sleep time 、total sleep time duration of different sleep periods、 sleep wake times etc.

Outcome：

Subjective observation indicators of insomnia symptoms

Type：

Primary indicator

Measure time point of outcome：

Before the first treatment intervention、 after the first course and the second course of treatment

Measure method：

The degree of insomnia symptoms was measured by Pittsburgh Sleep Quality Index (PSQI) and Athens Insomnia Scale (AIS).

Outcome：

General data observation

Type：

Additional indicator

Measure time point of outcome：

Evaluate once before treatment

Measure method：

Patient's age sex race marital status job type education level personal monthly income medical insurance Insurance type height weight; Fertility and menstruation; Present history past history drug use history allergy history etc.

Outcome：

Skin temperature monitoring

Type：

Secondary indicator

Measure time point of outcome：

Before the first treatment intervention、 after the first course and the second course of treatment

Measure method：

According to the skin temperature， the high precision intelligent temperature controller is used to monitor the temperature of specific acupoints on the skin

Outcome：

Subjective observation indicators of perimenopausal symptoms

Type：

Secondary indicator

Measure time point of outcome：

Before the first treatment intervention 、after the first course and the second course of treatment

Measure method：

The degree of perimenopausal symptoms was measured by modified kupperman score scale

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

blood

Fate of sample 

Destruction after use

Note：

Not yet recruiting

40
Min age years
60
Max age years

Recruiting status：

Participant age：

Gender：

Female

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

According to the order of treatment of each patient the researcher uses the RANDBETWEEN function in Excel to generate 99 on-board non-repeating integers ranging from 1 to 100 and rank them in ascending order. Subjects 1-33 34-66 and 67-99 were the control group test group 1 test group 2 respectively.

Blinding：

IPD sharing：

No

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

no public

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

Case Record Form CRF

Data Managemen Committee：

Not yet

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

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