Clinical Observation on the Treatment of Motor and Sensory Dysfunction After Stroke With Ruyizhenbao Pill

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.

Study Overview

• Status: Unknown
• Conditions: Post-stroke Patients With Motor and Sensory Dysfunction
• Intervention / Treatment: Drug: Ruyizhenbao Pill; Drug: Placebo of Ruyizhenbao Pill

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510006
      • Recruiting
      • Guangdong Provincial Hospital of Chinese Medicine
      • Contact: Ruihuan Pan; Phone Number: 02039318381 02039318381; Email: panruihuan@163.com
      • Contact: Shanshan Ling, Master; Phone Number: 020-39318381; Email: 1025286737@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Research group
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 Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.
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.	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.
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.	Modified Barthel Index will be tested before taking drugs, 4 weeks and 8weeks after taking drugs.Three times in total.
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.	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.
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.	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.
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.	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.

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: July 7, 2019
• First Submitted That Met QC Criteria: July 19, 2019
• First Posted (Actual): July 23, 2019

Study Record Updates

• Last Update Posted (Actual): September 23, 2019
• Last Update Submitted That Met QC Criteria: September 20, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Motor dysfunction; Post-stroke; Ruyizhenbao Pill; Sensory dysfunction
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2017-K-38

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No