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Clinical study on the treatment of abdominal obesity with spleen deficiency and dampness-blocking type by comprehensive moxibustion with Huolong Cupping

Registration number：

ITMCTR2024000265

Date of Last Refreshed on：

2024-08-20

Date of Registration：

2024-08-20

Registration Status：

Retrospective registration

Public title：

Clinical study on the treatment of abdominal obesity with spleen deficiency and dampness-blocking type by comprehensive moxibustion with Huolong Cupping

English Acronym：

Scientific title：

Clinical study on the treatment of abdominal obesity with spleen deficiency and dampness-blocking type by comprehensive moxibustion with Huolong Cupping

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

ChenZhenzhen

Study leader：

ChenZhenzhen

Applicant telephone：

15102005159

Study leader's telephone：

15102005159

Applicant Fax：

Study leader's fax：

Applicant E-mail：

568936184@qq.com

Study leader's E-mail：

568936184@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No.111, Dade Road, Yuexiu District, Guangzhou

Study leader's address：

No.111, Dade Road, Yuexiu District, Guangzhou

Applicant postcode：

510120

Study leader's postcode：

510120

Applicant's institution：

Guangdong Provincial Hospital of Chinese medicine

Approved by ethic committee：

Approved No. of ethic committee：

BF2023-340-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Guangdong Provincial Hospital of Chinese medicine

Date of approved by ethic committee：

2024/2/2 0:00:00

Contact Name of the ethic committee：

LiXiaoyan

Contact Address of the ethic committee：

No.111, Dade Road, Yuexiu District, Guangzhou

Contact phone of the ethic committee：

020-81887233转35943

Contact email of the ethic committee：

905150718@qq.com

Primary sponsor：

Guangdong Provincial Hospital of Chinese Medicine

Primary sponsor's address：

No.111, Dade Road, Yuexiu District, Guangzhou

Secondary sponsor：

Country：

China

Province：

Guangdong Province

City：

Guangzhou City

Institution
hospital：

Guangdong Provincial Hospital of Chinese medicine

Address：

No.111, Dade Road, Yuexiu District, Guangzhou

Source(s) of funding：

Guangdong Society of acupuncture and moxibustion

Target disease：

obesity

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

New Treatment Measure Clinical Study

Objectives of Study：

Main objective: To observe the efficacy and safety of comprehensive moxibustion with Huolong Cupping in the treatment of splenic deficiency and dampness-blocking obesity. Secondary objective: To establish the technical practice of abdominal Huolong Cupping therapy.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Meet the diagnostic criteria of Western medicine and Chinese medicine; ② Age ≥18 years old and ≤60 years old, can cooperate with treatment, observation and examination; ③ Informed consent to participate in the study voluntarily.

Exclusion criteria：

① Alcoholism, pregnancy, lactation, abnormal coagulation mechanism; ② Secondary obesity caused by other causes: hypothalamic and pituitary diseases, hypothyroidism, increased cortisol, increased insulin, gonadal secretion changes, water retention obesity, hereditary obesity syndrome and drug-induced obesity; ③ Patients with cardiovascular and cerebrovascular diseases, infectious diseases, diabetes, liver, kidney and hematopoietic system and other serious primary diseases, mental patients; ④ Patients who have received weight loss drugs or any other weight loss treatment within 3 months prior to treatment; ⑤ Patients who received lipid-lowering drugs within 3 months before treatment; ⑥ Allergic to moxa tobacco; 7 Abdominal skin damage, edema or vascular lesions; ⑧ organic diseases of abdominal organs, such as abdominal tumors, hemangiomas, etc.

Study execute time：

From 2023-01-01

To      2024-12-31

Recruiting time：

From 2024-08-01

To      2024-12-31

Interventions：

40

Group：

treatment group

Sample size：

Intervention：

Lifestyle intervention+abdominal Huolong Cupping therapy

Intervention code：

40

Group：

Control group

Sample size：

Intervention：

Lifestyle intervention

Intervention code：

Total sample size ： 80

Countries of recruitment
and research settings：

Country：

China

Province：

Guangdong Province

City：

Guangzhou City

Institution/hospital：

Guangdong Provincial Hospital of Chinese medicine

Level of the institution：

Grade 3 A

Outcomes：

Outcome：

Fat rate and obesity score of spleen deficiency and damp retention type (4,8 weeks)

Type：

Secondary indicator

Measure time point of outcome：

Before treatment, after 4 weeks, after 8 weeks, after 4, 8, 12, 16 weeks follow-up

Measure method：

Outcome：

BMI, waist circumference, weight (4, 8 weeks)

Type：

Primary indicator

Measure time point of outcome：

Before treatment, after 4 weeks, after 8 weeks, after 4, 8, 12, 16 weeks follow-up

Measure method：

Outcome：

TC、TG、HDL-C、LDL-C、非HDL-C

Type：

Secondary indicator

Measure time point of outcome：

Before treatment, after 8 weeks

Measure method：

Collecting sample(s)
from participants：

Sample Name：

no

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

18
Min age years
60
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Random number table method: 80 random numbers were obtained by the third party other than the researcher and the evaluator through SPSS25.0 software. The subjects were randomly divided into 2 groups according to the ratio of 1:1. Group A was the lifestyle intervention group, group B was lifestyle intervention + Fire Dragon Pot Group with 40 cases in each group.

Blinding：

This study can not be blinded to the subjects, only in the design of passwords, data storage and evaluation of the effect of evaluators by non-treatment professionals, reduce the bias caused by the researcher's supervisor.

IPD sharing：

Yes

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

http://www.medresman.org.cn/uc/index.aspx

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

The pathological report form shall be filled out by the patient and assisted by the full-time staff. The electronic collection and management system is specially entered and kept, and the second two are checked.

Data Managemen Committee：

Yes

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

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