To Evaluate the Clinical Efficacy of Zhuanyao Decoction in the Treatment of Degenerative Lumbar Spinal Stenosis Based on the Theory of 'Yanghua Qi'

• Register: ChiCTR
• Last refreshed on: 4 January 2022
• Main ID: ChiCTR2100046515
• Date of registration: 2021-05-18
• Prospective Registration: Yes
• Primary sponsor: Wang Jing Hospital, Chinese Academy of Traditional Chinese Medicine
• Public title: To Evaluate the Clinical Efficacy of Zhuanyao Decoction in the Treatment of Degenerative Lumbar Spinal Stenosis Based on the Theory of 'Yanghua Qi'
• Scientific title: To Evaluate the Clinical Efficacy of Zhuanyao Decoction in the Treatment of Degenerative Lumbar Spinal Stenosis Based on the Theory of 'Yanghua Qi'
• Date of first enrolment: 2021-06-01
• Target sample size: Treatment group:52;Control group:52;
• Recruitment status: Recruiting
• URL: http://www.chictr.org.cn/showproj.aspx?proj=126802
• Study type: Interventional study
• Study design: Parallel
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: Gao Jinghua
• Affiliation: Wang Jing Hospital, Chinese Academy of Traditional Chinese Medicine

• Name: Li Luguang
• Affiliation: Wang Jing Hospital, Chinese Academy of Traditional Chinese Medicine

Key inclusion & exclusion criteria

Inclusion criteria: 1.It meets the diagnostic criteria of lumbar spinal stenosis in western medicine;
2.In line with the TCM syndrome differentiation standard of spleen-kidney qi deficiency, phlegm and blood stasis;
3.Aged 45 to 70 years;
4.VAS score was 3-7;
5.Lumbar MRI showed central canal stenosis caused by the thickening of facet joints and ligamentum flavum, without the stenosis of nerve root canal caused by disc herniation.
6.Voluntarily signed informed consent;
7.If the patient has received other methods of treatment, has passed more than 7 days of washout period.
Only patients meet the above 7 criteria can be selected as eligible subjects for this clinical study.
Exclusion criteria: 1.With lumbar intervertebral disc herniation, lumbar tuberculosis, spondylolisthesis, congenital lumbar stenosis or spinal stenosis caused by inflammation, tumor, trauma, surgery;
2.Patients with severe surgical indications (patients with lower limb paralysis and defecation dysfunction and bedridden);
3.Pregnant or within half a year to prepare for pregnancy, lactating women;
4.Patients with heart, brain, liver, kidney, hematopoietic system and other serious primary diseases;
5.People with allergies or known allergies to the drugs and their components used in this study;
6.Not suitable for the special population to participate in clinical research (blind, deaf, dumb, intellectual or mental disorders, etc.);
7.Patients enrolled in other clinical trials within 3 months.
8.Patients with contraindications to celecoxib capsule: contraindicated for coronary artery bypass bypass (CABG) surgery, active gastrointestinal ulcer/bleeding, severe heart failure, etc..
If any one of the above options is met, the case is excluded.

Age minimum: 45
Age maximum: 70
Gender: Both

Health Condition(s) or Problem(s) studied

Degenerative lumbar spinal stenosis

Intervention(s)

Treatment group:Zhuanyaotang Decoction granules + Mecobalamin tablets simulation agent+ Celecoxib capsules simulation agent;Control group:Methobalamin tablet + Celecoxib capsule + Zhuanyaotang Decoction granule simulation agent;

Primary Outcome(s)

Intermittent claudication distance;Pain visual analogue scales score;Oswestry disability index;

Secondary Outcome(s)

Curative effect of lumbago disease;Lumbar motion;Traditional Chinese medicine syndrome integral;

Secondary ID(s)

ChiMCTR2100004862

Source(s) of Monetary Support

Beijing Administration of Traditional Chinese Medicine

Ethics review

Status: Approved
Approval date: 12/03/2021
Contact:

Wang Hao