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A multicenter, double-blind, double-dummy, randomized controlled trial of the Chinese herbal medicine Linggui granule for patients with asthenospermia

Registration number：

ITMCTR2200005858

Date of Last Refreshed on：

2022-04-13

Date of Registration：

2022-04-13

Registration Status：

Prospective registration

Public title：

A multicenter, double-blind, double-dummy, randomized controlled trial of the Chinese herbal medicine Linggui granule for patients with asthenospermia

English Acronym：

Scientific title：

A multicenter, double-blind, double-dummy, randomized controlled trial of the Chinese herbal medicine Linggui granule for patients with asthenospermia

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200058672 ; ChiMCTR2200005858

Applicant：

Liu shengjing

Study leader：

Guo jun

Applicant telephone：

18813004617

Study leader's telephone：

010-62835134

Applicant Fax：

Study leader's fax：

Applicant E-mail：

liu-shengjing@qq.com

Study leader's E-mail：

guojun1126@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

1 Xiyuan Caochang, Haidian District, Beijing

Study leader's address：

1 Xiyuan Caochang, Haidian District, Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China

Approved by ethic committee：

Approved No. of ethic committee：

2021XLA114-2

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences

Date of approved by ethic committee：

2022/1/13 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China

Primary sponsor's address：

Xiyuan Hospital of China Academy of Chinese Medical Sciences, No.1 Xiyuan Caochang Road, Haidian District, Beijing,

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Address：

Xiyuan Hospital of China Academy of Chinese Medical Sciences, No.1 Xiyuan Caochang Road, Haidian District, Beijing,

Source(s) of funding：

Scientific and Technological Innovation Project of China Academy of Chinese Medical Sciences

Target disease：

asthenospermia

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

To evaluate the efficacy and safety of Linggui granule for patients with asthenospermia

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1) Study participants must meet the diagnostic criteria of male infertility. (2) Study participants must meet the diagnostic criteria of AZS. (3) Men aged 22 to 45 years (4) The participant must sign informed consent forms

Exclusion criteria：

(1)with infertility caused by organic lesions of the reproductive system (2)with infertility caused by the inability to complete sexual intercourse, including but not limited to erectile dysfunction, ejaculatory disorder (3)with reproductive system infection, such as chlamydia trachomatis or mycoplasma infection (4)with abnormal sex hormone (5)with palpable varicocele (6)with a history of allergy to any medicine or ingredients used in this study (7)complicated with mental diseases, malignant tumors, or serious organic diseases (8)use drugs affecting the experimental study within 3 months

Study execute time：

From 2022-03-01

To      2024-06-01

Recruiting time：

From 2022-08-01

To      2024-01-01

Interventions：

73

Group：

control group

Sample size：

Intervention：

levocarnitine oral solution+Linggui granule mimetics

Intervention code：

73

Group：

treatment group

Sample size：

Intervention：

Linggui granule and levocarnitine oral solution mimetics

Intervention code：

Total sample size ： 146

Countries of recruitment
and research settings：

Country：

China

Province：

tianjin

City：

Institution/hospital：

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Level of the institution：

tertiary grade A hospitals

Country：

China

Province：

jinan

City：

Institution/hospital：

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Level of the institution：

tertiary grade A hospitals

Country：

China

Province：

chengdu

City：

Institution/hospital：

Reproductive Maternal and Child Hospital, Chengdu University of Traditional Chinese Medicine

Level of the institution：

tertiary grade A hospitals

Country：

China

Province：

beijing

City：

Institution/hospital：

Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China

Level of the institution：

tertiary grade A hospitals

Outcomes：

Outcome：

PR+NP sperm rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

PR sperm rate

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

spouse pregnancy rate

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

total effective sperm count

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

sperm DNA fragmentation index

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

blood

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

sperm

Tissue：

Fate of sample 

Destruction after use

Note：

Sample Name：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

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)：

The randomization sequence number will be generated by a professional statistician in Xiyuan Hospital using the SAS software.

Blinding：

IPD sharing：

Yes

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

Share raw data in paper form after research

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：

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

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