Back to resultsClinical Observation on the Treatment of Motor and Sensory Dysfunction After Stroke With Ruyizhenbao Pill
Primary Purpose
Post-stroke Patients With Motor and Sensory Dysfunction
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Ruyizhenbao Pill
Placebo of Ruyizhenbao Pill
Sponsored by
About this trial
This is an interventional treatment trial for Post-stroke Patients With Motor and Sensory Dysfunction focused on measuring Ruyizhenbao Pill, Post-stroke, Motor dysfunction, Sensory dysfunction
Eligibility Criteria
Inclusion Criteria:
- Compliance with stroke diagnostic criteria;
- The course of the disease is 15 days to 6 months;
- People who are conscious and have no severe cognitive impairment, and those who cooperate with examination and treatment;
- Age 20 to 80 years old;
- Sign an informed consent and participate voluntarily in the study.
Exclusion Criteria:
- Diseases such as brain tumours, traumatic brain injury, brain parasitic diseases and metabolic disorders have been confirmed by examination;
- Combining patients with severe heart, liver, kidney, hematopoietic and endocrine systems, gastrointestinal diseases, etc.;
- Those who are not aware or concoced due to more severe cognitive impairment and complete aphasia;
- People who are allergic to the drug or are allergic to multiple medications.
Sites / Locations
- Guangdong Provincial Hospital of Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Research group
Control group
Arm Description
Subjects who are recruited into this group are asked to take the Ruyizhenbao Pill on the basis of routine internal medicine and rehabilitation treatment. P.S. Ruyizhenbao Pills are provided by Jinhe Tibetan Pharmaceutical Co., Ltd. Chinese national medicine permission number:Z63020289、Z63020064. Medication method: oral 4 pills once, twice a day, 4 weeks in a row.
Subjects who are recruited into this group are asked to take the placebo of Ruyizhenbao Pill on the basis of routine internal medicine and rehabilitation treatment. P.S. Placebo is provided by Jinhe Tibetan Pharmaceutical Co., Ltd.，which is made of malt dextrin as a matrix, similar shape and same color to the Ruyizhenbao Pill. Medication method: oral 4 pills once, twice a day, 4 weeks in a row.
Outcomes
Primary Outcome Measures
Motor function change
Using Simplified Fugl-Meyer motion function assessment method to assess the motor function of affected side.The total score of Fugl-Meyer motor function assessment scale is 100 points，50 items intotal with 2 points each. Accordding to the quality of mission completion，evaluater mark score of "0","1",2".Among them, 33 items are evaluated for upper limbs, with a total score of 66 points. And 17 items are evaluated for lower limbs,with a total score of 34 points.The higher the scores, the better motor function.If the total score is less than 50, it means severe dyskinesia.If the total score is between 50-84, it means obvious movement disorder.If the total score is between 85-95, it means moderate dyskinesia.If the total score is between 96-100, it means mild dyskinesia.
Sensory function change
Using Simplified Fugl-Meyer sensory function assessment scale to assess the sensory function of affected side,which includes light touch and proprioception. Light touch includes 4 parts, which are respectively upper arm, palm, thigh, foot. Proprioception includes 7 parts,which are respectively shoulder, elbow, wrist, thumb, knee, ankle, toe joint. The total score of each part is 2,the total scores of this scale is 22."0" score means no feeling，"1" score means feeling allergic or diminished，"2"scores means normal feeling.The sum of the scores of each part is the total score. The higher the total scores,the better the sensory function.
Activity of daily living(ADL)change
Using Modified Barthel Index to assess the activity of daily living. TheMBI scale includes 11 items with total scores of 100. Evaluation is based on the actual situation of the patient.The sum of the scores of each item is the total score,and the lowest score is"0",the highest scores is"100".If the scores is between 0-20 points,it means extremely severe dysfunction.If the scores is between 25-45 points,it means severe dysfunction.If the scores is between 50-70 points it means moderate functional defects.If the scores is between 75-95 points,it means mild functional defects.If the scores is 100 points,it means ADL self-care.The higher the total scores,the better the ADL.
Survival Quality Score change
Special scale of quality of life is used to test the survival quality this week. 3 selected questions are evalusted and there are 5 selections for each question. "1" means "Exactly"，"2" means "Basically"，"3"means "Not sure"，"4"means "Basically not"，"5"means "Absolutely not".The sum of the scores of each question is the total score. The higher the total scores,the better the survival quality.
Berg Balance Function change
Berg balance function scale is to assess the balance function.It contains 14 instructions with total scores of 56.Each instruction includes 5 selections respectively for"0","1","2","3","4".The sum of the scores of each instruction is the total score. The higher the total scores,the better the balance function.
Painful degree change
Visual analog scale(VAS) is used to test the painful degree. It contains 0-10 scores,while "0"means no pain, "10"means most severe painful.The higher the scores,the more painful.
Secondary Outcome Measures
Full Information
NCT ID
NCT04029701
First Posted
July 7, 2019
Last Updated
September 20, 2019
Sponsor
Guangzhou University of Traditional Chinese Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04029701
Brief Title
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
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangzhou University of Traditional Chinese Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Patients With Motor and Sensory Dysfunction
Keywords
Ruyizhenbao Pill, Post-stroke, Motor dysfunction, Sensory dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This Trials is a randomly controlled, double-blinded and placebo-controlled trial.And the methodology team of Guangdong Provincial Hospital of Chinese Medicine is responsible for the editing of blindness.
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Research group
Arm Type
Experimental
Arm Description
Subjects who are recruited into this group are asked to take the Ruyizhenbao Pill on the basis of routine internal medicine and rehabilitation treatment.
P.S. Ruyizhenbao Pills are provided by Jinhe Tibetan Pharmaceutical Co., Ltd. Chinese national medicine permission number:Z63020289、Z63020064. Medication method: oral 4 pills once, twice a day, 4 weeks in a row.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Subjects who are recruited into this group are asked to take the placebo of Ruyizhenbao Pill on the basis of routine internal medicine and rehabilitation treatment.
P.S. Placebo is provided by Jinhe Tibetan Pharmaceutical Co., Ltd.，which is made of malt dextrin as a matrix, similar shape and same color to the Ruyizhenbao Pill. Medication method: oral 4 pills once, twice a day, 4 weeks in a row.
Intervention Type
Drug
Intervention Name(s)
Ruyizhenbao Pill
Other Intervention Name(s)
Research group
Intervention Description
Ruyizhenbao Pills are provided by Jinhe Tibetan Pharmaceutical Co., Ltd. Chinese national medicine permission number:Z63020289、Z63020064. Medication method: oral 4 pills once, twice a day, 4 weeks in a row.
Intervention Type
Drug
Intervention Name(s)
Placebo of Ruyizhenbao Pill
Other Intervention Name(s)
Control group
Intervention Description
Placebo is provided by Jinhe Tibetan Pharmaceutical Co., Ltd.，which is made of malt dextrin as a matrix, similar shape and same color to the Ruyizhenbao Pill. Medication method: oral 4 pills once, twice a day, 4 weeks in a row.
Primary Outcome Measure Information:
Title
Motor function change
Description
Using Simplified Fugl-Meyer motion function assessment method to assess the motor function of affected side.The total score of Fugl-Meyer motor function assessment scale is 100 points，50 items intotal with 2 points each. Accordding to the quality of mission completion，evaluater mark score of "0","1",2".Among them, 33 items are evaluated for upper limbs, with a total score of 66 points. And 17 items are evaluated for lower limbs,with a total score of 34 points.The higher the scores, the better motor function.If the total score is less than 50, it means severe dyskinesia.If the total score is between 50-84, it means obvious movement disorder.If the total score is between 85-95, it means moderate dyskinesia.If the total score is between 96-100, it means mild dyskinesia.
Time Frame
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.
Title
Sensory function change
Description
Using Simplified Fugl-Meyer sensory function assessment scale to assess the sensory function of affected side,which includes light touch and proprioception. Light touch includes 4 parts, which are respectively upper arm, palm, thigh, foot. Proprioception includes 7 parts,which are respectively shoulder, elbow, wrist, thumb, knee, ankle, toe joint. The total score of each part is 2,the total scores of this scale is 22."0" score means no feeling，"1" score means feeling allergic or diminished，"2"scores means normal feeling.The sum of the scores of each part is the total score. The higher the total scores,the better the sensory function.
Time Frame
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.
Title
Activity of daily living(ADL)change
Description
Using Modified Barthel Index to assess the activity of daily living. TheMBI scale includes 11 items with total scores of 100. Evaluation is based on the actual situation of the patient.The sum of the scores of each item is the total score,and the lowest score is"0",the highest scores is"100".If the scores is between 0-20 points,it means extremely severe dysfunction.If the scores is between 25-45 points,it means severe dysfunction.If the scores is between 50-70 points it means moderate functional defects.If the scores is between 75-95 points,it means mild functional defects.If the scores is 100 points,it means ADL self-care.The higher the total scores,the better the ADL.
Time Frame
Modified Barthel Index will be tested before taking drugs, 4 weeks and 8weeks after taking drugs.Three times in total.
Title
Survival Quality Score change
Description
Special scale of quality of life is used to test the survival quality this week. 3 selected questions are evalusted and there are 5 selections for each question. "1" means "Exactly"，"2" means "Basically"，"3"means "Not sure"，"4"means "Basically not"，"5"means "Absolutely not".The sum of the scores of each question is the total score. The higher the total scores,the better the survival quality.
Time Frame
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.
Title
Berg Balance Function change
Description
Berg balance function scale is to assess the balance function.It contains 14 instructions with total scores of 56.Each instruction includes 5 selections respectively for"0","1","2","3","4".The sum of the scores of each instruction is the total score. The higher the total scores,the better the balance function.
Time Frame
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.
Title
Painful degree change
Description
Visual analog scale(VAS) is used to test the painful degree. It contains 0-10 scores,while "0"means no pain, "10"means most severe painful.The higher the scores,the more painful.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Compliance with stroke diagnostic criteria;
The course of the disease is 15 days to 6 months;
People who are conscious and have no severe cognitive impairment, and those who cooperate with examination and treatment;
Age 20 to 80 years old;
Sign an informed consent and participate voluntarily in the study.
Exclusion Criteria:
Diseases such as brain tumours, traumatic brain injury, brain parasitic diseases and metabolic disorders have been confirmed by examination;
Combining patients with severe heart, liver, kidney, hematopoietic and endocrine systems, gastrointestinal diseases, etc.;
Those who are not aware or concoced due to more severe cognitive impairment and complete aphasia;
People who are allergic to the drug or are allergic to multiple medications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongxia Chen, Master
Phone
020-39318381
Ext
02081887233
Email
chx2004@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ruihuan Pan, Dotor
Phone
020-39318381
Email
panruihuan@163.com
Facility Information:
Facility Name
Guangdong Provincial Hospital of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruihuan Pan
Phone
02039318381
Ext
02039318381
Email
panruihuan@163.com
First Name & Middle Initial & Last Name & Degree
Shanshan Ling, Master
Phone
020-39318381
Email
1025286737@qq.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35723814
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.
Results Reference
derived
Learn more about this trial
Clinical Observation on the Treatment of Motor and Sensory Dysfunction After Stroke With Ruyizhenbao Pill
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