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出境医 / 临床实验 / Clinical Observation on the Treatment of Motor and Sensory Dysfunction After Stroke With Ruyizhenbao Pill
Clinical Observation on the Treatment of Motor and Sensory Dysfunction After Stroke With Ruyizhenbao Pill
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Post-stroke Patients With Motor and Sensory Dysfunction | Drug: Ruyizhenbao Pill Drug: Placebo of Ruyizhenbao Pill | Phase 2 |
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes 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. |
| Primary Purpose: | Treatment |
| Official Title: | Clinical Observation on the Treatment of Motor and Sensory Dysfunction After Stroke With Ruyizhenbao Pill |
| Actual Study Start Date : | January 1, 2017 |
| Estimated Primary Completion Date : | December 31, 2019 |
| Estimated Study Completion Date : | December 31, 2019 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Research group
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. |
Drug: Ruyizhenbao Pill
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.
Other Name: Research group
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Placebo Comparator: Control group
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. |
Drug: Placebo of Ruyizhenbao Pill
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.
Other Name: Control group
|
Outcome Measures
Primary Outcome Measures :
- Motor function change [ 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. ]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 [ 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. ]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 [ Time Frame: Modified Barthel Index will be tested before taking drugs, 4 weeks and 8weeks after taking drugs.Three times in total. ]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 [ 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. ]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 [ 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. ]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 [ 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. ]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.
Eligibility Criteria
| Ages Eligible for Study: | 20 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Contacts
| Contact: Hongxia Chen, Master | 020-39318381 ext 02081887233 | chx2004@126.com | |
| Contact: Ruihuan Pan, Dotor | 020-39318381 | panruihuan@163.com |
Locations
| China, Guangdong | |
| Guangdong Provincial Hospital of Chinese Medicine | Recruiting |
| Guangzhou, Guangdong, China, 510006 | |
| Contact: Ruihuan Pan 02039318381 ext 02039318381 panruihuan@163.com | |
| Contact: Shanshan Ling, Master 020-39318381 1025286737@qq.com | |
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 7, 2019 | ||||||||
| First Posted Date ICMJE | July 23, 2019 | ||||||||
| Last Update Posted Date | September 23, 2019 | ||||||||
| Actual Study Start Date ICMJE | January 1, 2017 | ||||||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Clinical Observation on the Treatment of Motor and Sensory Dysfunction After Stroke With Ruyizhenbao Pill | ||||||||
| Official Title ICMJE | Clinical Observation on the Treatment of Motor and Sensory Dysfunction After Stroke With Ruyizhenbao Pill | ||||||||
| 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 2 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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. Primary Purpose: Treatment
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| Condition ICMJE | Post-stroke Patients With Motor and Sensory Dysfunction | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
120 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | December 31, 2019 | ||||||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 20 Years to 80 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04029701 | ||||||||
| Other Study ID Numbers ICMJE | 2017-K-38 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Guangzhou University of Traditional Chinese Medicine | ||||||||
| Study Sponsor ICMJE | Guangzhou University of Traditional Chinese Medicine | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| PRS Account | Guangzhou University of Traditional Chinese Medicine | ||||||||
| Verification Date | September 2019 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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