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A multi-center randomized double-blind double-dummy positive-drug parallel controlled clinical trial of Mailuoshutong Pills in the treatment of deep vein thrombosis of lower limbs (damp-heat stasis syndrome)

Registration number：

ITMCTR2025000063

Date of Last Refreshed on：

2025-01-10

Date of Registration：

2025-01-10

Registration Status：

Retrospective registration

Public title：

A multi-center randomized double-blind double-dummy positive-drug parallel controlled clinical trial of Mailuoshutong Pills in the treatment of deep vein thrombosis of lower limbs (damp-heat stasis syndrome)

English Acronym：

Scientific title：

A multi-center randomized double-blind double-dummy positive-drug parallel controlled clinical trial of Mailuoshutong Pills in the treatment of deep vein thrombosis of lower limbs (damp-heat stasis syndrome)

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Jiang Yanling

Study leader：

Yang Bohua

Applicant telephone：

150 9886 0396

Study leader's telephone：

13601038551

Applicant Fax：

Study leader's fax：

Applicant E-mail：

m15098860396@163.com

Study leader's E-mail：

yangb5191@sina.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 209 Hongqi Road Lanshan District Linyi City Shandong Province

Study leader's address：

No.5 Marine Warehouse Dongcheng District Beijing

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Lunan Houpu Pharmaceutical Co. Ltd.

Approved by ethic committee：

Approved No. of ethic committee：

2024DZMEC-385-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/8/21 0:00:00

Contact Name of the ethic committee：

Han Xue-ting

Contact Address of the ethic committee：

No. 5 Dongcheng District Ocean Warehouse Beijing

Contact phone of the ethic committee：

010-84012790

Contact email of the ethic committee：

dzmyyec@126.com

Primary sponsor：

Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine

Primary sponsor's address：

No. 5 Dongcheng District Ocean Warehouse Beijing

Secondary sponsor：

Country：

China

Province：

Beijing

City：

Institution
hospital：

Dongzhimen Hospital Beijing University of Traditional Chinese Medicine

Address：

No.5, Marine Warehouse, Dongcheng District, Beijing

Source(s) of funding：

Lunan Houpu Pharmaceutical Co. Ltd.

Target disease：

deep vein thrombosis of lower limbs

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Post-marketing clinical trial

Objectives of Study：

1.Using Mailuoning Granules as a comparison evaluate the effectiveness and advantages of Mailuoshutong Pills in the treatment of deep vein thrombosis of lower limbs (damp-heat stasis syndrome) in swelling and pain; 2.Observe the safety of clinical use of Mailu Shutong Pills.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

(1)For those who meet the Western medical diagnostic criteria for deep vein thrombosis of the lower limbs the clinical stage is the delayed stage (non-acute stage) which is 14 days to 3 months after the onset of disease; (2)Meets the syndrome differentiation standards of damp-heat and blood stasis syndrome in traditional Chinese medicine; (3)Aged between 18 and 70 years old (including the boundary value) gender is not limited; (4)Voluntarily sign the subject informed consent form.

Exclusion criteria：

(1) Acute DVT patients who plan to undergo thrombus removal procedures including catheter contact thrombolysis (CDT) percutaneous mechanical thrombectomy (PMT) or surgical thrombectomy; (2)Mental illness combined with serious cardiovascular cerebrovascular liver kidney hematopoietic system and other serious complications or combined with other serious primary diseases ALT or AST > 1.5 times the upper limit of normal value Cr > the upper limit of normal value; (3)Those who have had level 3 or 4 surgery within 14 days; (4)Those with a history of hemorrhagic stroke within 3 months; (5)Various coagulation disorders such as hemophilia idiopathic thrombocytopenic purpura and other bleeding diseases and those with active bleeding in the past 2 weeks; (6)People with allergies or allergies to any ingredients in this product and excipients; (7)Pregnant lactating women and women with pregnancy potential who refuse to maintain contraceptive measures approved by the researcher throughout the study process; (8)People who have participated in other clinical trials in the past month; (9)People suspected of having a history of alcohol or drug abuse; (10)Other circumstances that the researcher considers unsuitable to participate in this study.

Study execute time：

From 2024-11-21

To      2026-04-30

Recruiting time：

From 2024-12-20

To      2025-12-10

Interventions：

120

Group：

experimental group

Sample size：

Intervention：

Mailuoshutong Pills + Mailuoning ranule Simulator，Mailuoshutong Pills: taken orally, 1 bottle at a time (12 pills/bottle), three times a day; Mailuoning granule simulant: taken as a drink, 1 bag each time (10g/ bag), three times a day.

Intervention code：

120

Group：

Control group

Sample size：

Intervention：

Mailuoning granules + Mailuoshutong pill simulation Mailuoning granules: taken as a drink 1 bag each time (10g/ bag) three times a day; Mailuoshutong pill simulator: taken orally 1 bottle at a time (12 pills/bottle) three times a day;

Intervention code：

Total sample size ： 240

Countries of recruitment
and research settings：

Country：

China

Province：

Jiangsu

City：

Institution/hospital：

Taizhou People's Hospital

Level of the institution：

Tertiary A

Country：

China

Province：

Inner Mongolia

City：

Institution/hospital：

Affiliated Hospital of Inner Mongolia Medical University

Level of the institution：

Tertiary A

Country：

China

Province：

Shaanxi

City：

Institution/hospital：

The First Affiliated Hospital of Xi'an Medical College

Level of the institution：

Tertiary A

Country：

China

Province：

Beijing

City：

Institution/hospital：

Beijing University of Chinese Medicine Oriental Hospital

Level of the institution：

Tertiary A

Country：

China

Province：

Shandong

City：

Institution/hospital：

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

Hebei

City：

Institution/hospital：

The First Affiliated Hospital of Hebei North University

Level of the institution：

Tertiary A

Country：

China

Province：

Tianjin

City：

Institution/hospital：

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

Country：

China

Province：

Shandong

City：

Institution/hospital：

Shandong Second People's Hospital

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Comprehensive disease efficacy (effective rate) after 4 weeks of treatment

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Comprehensive disease efficacy (effective rate) after 2 weeks of treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The efficacy of quantitative symptom scores (skin temperature, skin color, pain, swelling of the affected limb, Homans sign, vein patency rate) after 2 weeks and 4 weeks of treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Efficacy of traditional Chinese medicine syndrome after 2 weeks and 4 weeks of treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Disappearance rate of individual traditional Chinese medicine symptoms after 2 weeks and 4 weeks of treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Changes in inflammation-related indicators (erythrocyte sedimentation rate, C-reactive protein) from baseline after 4 weeks of treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Changes in D-dimer from baseline after 4 weeks of treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Changes in traditional Chinese medicine Life Quality Evaluation Scale (CQ-D11) scores from baseline after 2 weeks and 4 weeks of treatment

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Changes of NRS score of limb pain (swelling pain) NRS score of limb soreness and circumference of limb after 2 weeks and 4 weeks of treatment compared with baseline

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：

urine

Tissue：

Fate of sample 

Destruction after use

Note：

Recruiting

18
Min age years
70
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

A block randomization method was used. Select an appropriate block length and use SAS 9.4 statistical software to generate a random sequence of the treatment groups (experimental group control group) received by 240 subjects according to a 1:1 ratio based on the given random seed number and list the allocated drugs. The number is a random coding table.

Blinding：

IPD sharing：

Yes

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

Published academic papers

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

(Electronic Data Capture EDC）

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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