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Clinical observation on the treatment of lumbar disc herniation (liver and kidney deficiency syndrome) in the middle-aged and elderly with a self-made Bushen Huoxue Prescription combined with lysis of lumbar nerve root adhesions under anesthesia

Registration number：

ITMCTR2024000544

Date of Last Refreshed on：

2024-10-14

Date of Registration：

2024-10-14

Registration Status：

Retrospective registration

Public title：

Clinical observation on the treatment of lumbar disc herniation (liver and kidney deficiency syndrome) in the middle-aged and elderly with a self-made Bushen Huoxue Prescription combined with lysis of lumbar nerve root adhesions under anesthesia

English Acronym：

Scientific title：

Clinical observation on the treatment of lumbar disc herniation (liver and kidney deficiency syndrome) in the middle-aged and elderly with a self-made Bushen Huoxue Prescription combined with lysis of lumbar nerve root adhesions under anesthesia

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Su Haiyang

Study leader：

Shi Ying

Applicant telephone：

15295606665

Study leader's telephone：

13621612201

Applicant Fax：

Study leader's fax：

Applicant E-mail：

hysu_99@163.com

Study leader's E-mail：

shiying1974@126.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

No. 20 Building 17 Lane 280 Huatuo Road Pudong New District Shanghai China

Study leader's address：

No. 528 Zhangheng Road Pudong New District Shanghai China

Applicant postcode：

201203

Study leader's postcode：

201203

Applicant's institution：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2024-1451-034-01

Approved file of Ethical Committee：

View

Name of the ethic committee：

EC of Shuguang Hospital affiliated to Shanghai University of TCM

Date of approved by ethic committee：

2024/3/11 0:00:00

Contact Name of the ethic committee：

Ma Junjian

Contact Address of the ethic committee：

No. 528 Zhangheng Road Pudong New District Shanghai China

Contact phone of the ethic committee：

021-20256070

Contact email of the ethic committee：

sgyyllwyh@126.com

Primary sponsor：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Primary sponsor's address：

No. 528 Zhangheng Road Pudong New District Shanghai China

Secondary sponsor：

Country：

China

Province：

Shanghai

City：

Pudong New District

Institution
hospital：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Address：

No. 528 Zhangheng Road Pudong New District Shanghai China

Source(s) of funding：

researcher self-funded

Target disease：

lumbar disc herniation

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

This study aimed to compare the two schemes of lysis of lumbar nerve root adhesions under anesthesia alone and combined with Bushen Huoxue Prescription in order to verify the exact efficacy of Bushen Huoxue Prescription combined with lysis of lumbar nerve root adhesions under anesthesia in the treatment of lumbar disc herniation in middle-aged and elderly people.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Meet the diagnostic criteria for lumbar disc herniation (liver and kidney deficiency syndrome). ② Age 45-70 years old regardless of gender. ③ Disease duration ≤ 3 months. ④ VAS score meets 4 ≤ VAS ≤ 7. ⑤ Those who have undergone lysis of lumbar nerve root adhesions under anesthesia and have not received other systemic treatment within 1 month. ⑥ Those who voluntarily participate in this study and sign the informed consent form.

Exclusion criteria：

① Women who are pregnant or breastfeeding. ② Those whose imaging examinations indicate huge lumbar disc herniation or prolapse (huge herniation: the protruding disc tissue exceeds 1/2 of the sagittal diameter of the spinal canal). ③ Cauda equina syndrome with obvious neurological damage especially urinary and bowel dysfunction. ④ Those with serious diseases such as cardiovascular liver kidney and blood system that make it difficult to cooperate. ⑤ Those with interfering diseases such as tumors tuberculosis ankylosing spondylitis etc. ⑥ Those with a history of allergy to the drugs involved in the study or obvious contraindications.

Study execute time：

From 2024-03-11

To      2025-03-10

Recruiting time：

From 2024-03-11

To      2025-03-10

Interventions：

42

Group：

control group

Sample size：

Intervention：

Lysis of lumbar nerve root adhesions under anesthesia alone

Intervention code：

42

Group：

experimental group

Sample size：

Intervention：

Bushen Huoxue Prescription combined with lysis of lumbar nerve root adhesions under anesthesia

Intervention code：

Total sample size ： 84

Countries of recruitment
and research settings：

Country：

China

Province：

Shanghai

City：

Pudong New District

Institution/hospital：

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution：

Grade 3 and First-class Hospital

Outcomes：

Outcome：

Oswestry Disability Index

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Visual Analogue Scale

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

The MOS Item Short From Health Survey

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Renal Function

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Blood Routine

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

Liver Function

Type：

Additional indicator

Measure time point of outcome：

Measure method：

Outcome：

TCM Syndrome Score

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：

Recruiting

45
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)：

The researchers used a completely random grouping method and generated a random number table using SPSS 25 software.

Blinding：

IPD sharing：

No

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

none

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

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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