Register Now
Log In
中文/English
About ITMCTR|Search Trials|About Us|News
Clinical observation of moxibustion in the treatment of oligoasthenoteratozoospermia

Registration number：

ITMCTR2024000093

Date of Last Refreshed on：

2024-06-06

Date of Registration：

2024-06-06

Registration Status：

Prospective registration

Public title：

Clinical observation of moxibustion in the treatment of oligoasthenoteratozoospermia

English Acronym：

Scientific title：

Clinical observation of acupuncture and moxibustion in the treatment of idiopathic oligoasthenoteratozoospermia based on the "Fuyang theory"

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Liang Shangjie

Study leader：

Qiu Shuo

Applicant telephone：

130 7349 0549

Study leader's telephone：

18118256591

Applicant Fax：

Study leader's fax：

Applicant E-mail：

lsj190225@163.com

Study leader's E-mail：

jamesdatto@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Nanjing University of Chinese Medicine, Nanjing 210023, Jiangsu Province, China

Study leader's address：

No. 577, Wenchang Middle Road, Yangzhou City, Jiangsu Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Nanjing University of Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

(2024)伦审第(22)号

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Yangzhou Hospital of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/5/24 0:00:00

Contact Name of the ethic committee：

Zhang Xiaochun

Contact Address of the ethic committee：

No. 577, Wenchang Middle Road, Yangzhou City, Jiangsu Province

Contact phone of the ethic committee：

18068846073

Contact email of the ethic committee：

595118716@qq.com

Primary sponsor：

Yangzhou Hospital of Traditional Chinese Medicine

Primary sponsor's address：

No. 577, Wenchang Middle Road, Yangzhou City, Jiangsu Province

Secondary sponsor：

Country：

China

Province：

Jiangsu

City：

Yangzhou

Institution
hospital：

Yangzhou Hospital of Traditional Chinese Medicine

Address：

No. 577, Wenchang Middle Road, Yangzhou City, Jiangsu Province

Source(s) of funding：

Yangzhou Science and Technology Plan Project (YZ2023087)

Target disease：

oligoasthenoteratozoospermia

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Pilot clinical trial

Objectives of Study：

The purpose of this study was to observe the efficacy and safety of moxibustion in the treatment of oligoasthenoteratozoospermia

Description for medicine or protocol of treatment in detail：

Inclusion criteria

（1）① sperm concentration < 15× 106/ml; Total sperm count < 39× 106/ml; ② PR < 32% or PR+NP < 40%; ③ Normal sperm morphology < 4%; . (2) Male between the ages of 22 (inclusive) ~ 40 years old (inclusive). (3) No male infertility related treatment within two weeks. (4) Agree to participate in clinical trials and sign informed consent.

Exclusion criteria：

(1) Male infertility caused by congenital malformations of the genital tract or organic diseases of the urinary system such as vas deferens obstruction; (2) Allergic constitution, known to be allergic to the drug components in this study; (3) Have serious primary heart, liver, lung, kidney, blood or serious diseases that affect their survival; (4) According to the judgment of the investigator, there are other pathologies that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment, which are easy to cause loss to follow-up; (5) Patients who are participating in clinical trials of other drugs;

Study execute time：

From 2024-04-30

To      2025-03-31

Recruiting time：

From 2024-06-10

To      2025-03-31

Interventions：

30

Group：

L-carnitine

Sample size：

Intervention：

L-carnitine oral liquid is taken orally. L-carnitine 10ml each time, 3 times a day, for 3 months.

Intervention code：

30

Group：

Moxibustion

Sample size：

Intervention：

Moxibustion at "Guanyuan" acupoint, 9 zhuang each time. Make a high proportion of moxa wool into 5mg / strong wheat grain moxa wick. After disinfection, apply an appropriate amount of vaseline fixed moxa wick on the acupoints and light it with incense until it burns out. Treatment once a week for 12 weeks

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Jiangsu

City：

Yangzhou

Institution/hospital：

Yangzhou Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Sperm quality analysis

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Pregnancy rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Safety Assessment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

DFI

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Serum sex hormone levels

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

semen

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

22
Min age years
40
Max age years

Recruiting status：

Participant age：

Gender：

Male

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

This part will be carried out by an independent statistician, and the random grouping will be completed with the help of Excel. Sixty random numbers will be divided into drug group and moxibustion group according to the ratio of 1∶1. After random grouping, the information will be put into an opaque and sealed envelope, and the number of the envelope is consistent with the number on the digital card. According to the order of patients entering the study, the cards will be unpacked according to the envelope number and grouped strictly according to the card information. There were 30 cases in the drug group and 30 cases in the moxibustion group.

Blinding：

IPD sharing：

Yes

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

Obtained after communicating with the project leader

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

Case Record Form

Data Managemen Committee：

Yes

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

back
Platform information
About ITMCTR
About Us
Register Trials
Frequently Asked Questions
Ethical Review
The public service
Search Trials
Join Us
ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above