Clinical trial NCT04029701: Clinical Observation on the Treatment of Motor and Sensory Dysfunction After Stroke With Ruyizhenbao Pill
Official title: Clinical Observation on the Treatment of Motor and Sensory Dysfunction After Stroke With Ruyizhenbao Pill
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Post-stroke Patients With Motor and Sensory Dysfunction
Keywords: Ruyizhenbao Pill
Post-stroke
Motor dysfunction
Sensory dysfunction
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many years of clinical practice experience has found that Ruyi treasure pill can be used to treat nerve meridian injury caused by cerebrovascular disease, but in the end, the clinical efficacy is still lacking systematic clinical evidence-based medical research data. Based on this, the clinical observation of Ruyi treasure pill in the treatment of post-stroke motor and sensory dysfunction was carried out to verify its clinical location, to provide evidence for the application of clinical subdivision of later products and two development of products, and to publish academic papers on the expected research results.


Eligibility criteria: Inclusion Criteria:

1. Compliance with stroke diagnostic criteria;
2. The course of the disease is 15 days to 6 months;
3. People who are conscious and have no severe cognitive impairment, and those who cooperate with examination and treatment;
4. Age 20 to 80 years old;
5. Sign an informed consent and participate voluntarily in the study.

Exclusion Criteria:

1. Diseases such as brain tumours, traumatic brain injury, brain parasitic diseases and metabolic disorders have been confirmed by examination;
2. Combining patients with severe heart, liver, kidney, hematopoietic and endocrine systems, gastrointestinal diseases, etc.;
3. Those who are not aware or concoced due to more severe cognitive impairment and complete aphasia;
4. People who are allergic to the drug or are allergic to multiple medications.

Primary outcomes:
measure: Motor function change
timeFrame: The simplified Fugl-Meyer motion function scale will be tested totally twice,separately at before taking drugs, 4 weeks and 8 weeks after taking drugs so as to compare changes among three time points.
measure: Sensory function change
timeFrame: Simplified Fugl-Meyer sensory function scale will be tested before taking drugs, 4 weeks and 8weeks after taking drugs so as to compare changes at three time points.Three times in total.
measure: Activity of daily living(ADL)change
timeFrame: Modified Barthel Index will be tested before taking drugs, 4 weeks and 8weeks after taking drugs.Three times in total.
measure: Survival Quality Score change
timeFrame: Special scale of quality of life will be tested before taking drugs, 4 weeks and 8weeks after taking drugs so as to compare changes at three time points.Three times in total.
measure: Berg Balance Function change
timeFrame: Berg Balance Function Scale will be tested before taking drugs, 4 weeks and 8weeks after taking drugs so as to compare changes at three time points.Three times in total.
measure: Painful degree change
timeFrame: VAS will be tested before taking drugs, 4 weeks and 8weeks after taking drugs so as to compare changes at three time points.Three times in total.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
Study officials:
References:
citation: Ling SS, Pan RH, Zhan LC, Li M, Yang ZJ, Yang HD, Chen HX. Ruyi Zhenbao Pills for Patients with Motor and Sensory Dysfunction after Stroke: A Double-Blinded, Randomized Placebo-Controlled Clinical Trial. Chin J Integr Med. 2022 Oct;28(10):872-878. doi: 10.1007/s11655-022-3577-9. Epub 2022 Jun 20.