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Clinical Study of Qingpeng Ointment in Treating Shoulder Syndrome During Rehabilitation Period of Cerebral Hemorrhage

Primary Purpose

The Efficacy of Qingpeng Ointment

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Qingpeng Ointment
Sponsored by
Guangzhou University of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for The Efficacy of Qingpeng Ointment focused on measuring Qingpeng Ointment, Shoulder Syndrome, Rehabilitation Period of Cerebral Hemorrhage

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Meet the diagnostic criteria for stroke;
  2. Meet the diagnostic criteria for shoulder-hand syndrome, stage I
  3. The course of disease is between 15 days and 6 months;
  4. Consciousness, no serious cognitive impairment, with examination and treatment;
  5. Age between 20 and 80 years old;
  6. Sign the informed consent form and volunteer to participate in the study.

Exclusion Criteria:

  1. Repeated stroke patients or shoulder-hand syndrome patients with repeated attacks or exacerbations;
  2. The course of stroke is >6 months;
  3. Those with serious heart, liver and kidney diseases and moderate to severe infections;
  4. Unconsciousness or a combination of incompetent cognitive impairment and complete aphasia.
  5. Take painkillers or other treatments that treat shoulder pain.

Sites / Locations

  • Guangdong Provincial Hospital of Chinese medicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Control Group

Arm Description

Take Qingpeng ointment (produced by Tibet Qizheng Tibetan Medicine Co., Ltd.) and apply it evenly on the shoulder joints, wrist joints and palms of the upper limbs. Press for 20 minutes and have rehabilitation training afer 10 minutes.

Outcomes

Primary Outcome Measures

Painful degree change of ipsilateral shoulder
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.
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.
Activity of daily living change (ADL)
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.
Shoulder joint mobility change
Test the shoulder joint mobility with a protractor.The movements of the shoulder joints are as follows:Flexion：70-90°；Stretch：40°；Outreach：80-90°；Adduction：40-60°；Pronation：70-90°；External rotation：15°；Lift up：160-180°.The bigger the degrees，the better the shoulder joint mobility.

Secondary Outcome Measures

Safety evaluation
Safety rating includes 4 levels.Level 1 means "Safe, without any adverse reactions".Level 2 means "Safer, if there is an adverse reaction, you can continue treatment without any treatment ".Level 3 means " Have safety problems, have moderate adverse reactions, and continue treatment after treatment". Level 4 means " Suspension test due to adverse reactions".

Full Information

First Posted
July 23, 2019
Last Updated
September 20, 2019
Sponsor
Guangzhou University of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04039737
Brief Title
Clinical Study of Qingpeng Ointment in Treating Shoulder Syndrome During Rehabilitation Period of Cerebral Hemorrhage
Official Title
Clinical Study of Qingpeng Ointment in Treating Shoulder Syndrome During Rehabilitation Period of Cerebral Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 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
A randomized, controlled study is conducted. 120 patients with post-stroke shoulder-shoulder syndrome who meet the inclusion criteria are randomized into treatment group and control group, 60 patients in each group. The treatment group is treated with Qingpeng ointment. The goal of this trial is to verify the clinical efficacy of Tibetan medicine Qingpeng ointment in improving post-stroke shoulder-hand syndrome, and to investigate its effect on pain level, swelling degree, hand movement function, activity and activities of daily living.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
The Efficacy of Qingpeng Ointment
Keywords
Qingpeng Ointment, Shoulder Syndrome, Rehabilitation Period of Cerebral Hemorrhage

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Take Qingpeng ointment (produced by Tibet Qizheng Tibetan Medicine Co., Ltd.) and apply it evenly on the shoulder joints, wrist joints and palms of the upper limbs. Press for 20 minutes and have rehabilitation training afer 10 minutes.
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Qingpeng Ointment
Intervention Description
Take Qingpeng ointment (produced by Tibet Qizheng Tibetan Medicine Co., Ltd.) and apply it evenly on the shoulder joints, wrist joints and palms of the upper limbs. Press for 20 minutes and have rehabilitation training afer 10 minutes.
Primary Outcome Measure Information:
Title
Painful degree change of ipsilateral shoulder
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 treatment and after a 4-week treatment so as to compare the efficacy.Twice in total
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
This scale will be tested before treatment and after a 4-week treatment so as to compare the efficacy.Twice in total
Title
Activity of daily living change (ADL)
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
This scale will be tested before treatment and after a 4-week treatment so as to compare the efficacy.Twice in total
Title
Shoulder joint mobility change
Description
Test the shoulder joint mobility with a protractor.The movements of the shoulder joints are as follows:Flexion：70-90°；Stretch：40°；Outreach：80-90°；Adduction：40-60°；Pronation：70-90°；External rotation：15°；Lift up：160-180°.The bigger the degrees，the better the shoulder joint mobility.
Time Frame
These will be tested before treatment and after a 4-week treatment so as to compare the efficacy.Twice in total
Secondary Outcome Measure Information:
Title
Safety evaluation
Description
Safety rating includes 4 levels.Level 1 means "Safe, without any adverse reactions".Level 2 means "Safer, if there is an adverse reaction, you can continue treatment without any treatment ".Level 3 means " Have safety problems, have moderate adverse reactions, and continue treatment after treatment". Level 4 means " Suspension test due to adverse reactions".
Time Frame
After 4 weeks of treatment, evaluate adverse reactions and make a record.

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: Meet the diagnostic criteria for stroke; Meet the diagnostic criteria for shoulder-hand syndrome, stage I The course of disease is between 15 days and 6 months; Consciousness, no serious cognitive impairment, with examination and treatment; Age between 20 and 80 years old; Sign the informed consent form and volunteer to participate in the study. Exclusion Criteria: Repeated stroke patients or shoulder-hand syndrome patients with repeated attacks or exacerbations; The course of stroke is >6 months; Those with serious heart, liver and kidney diseases and moderate to severe infections; Unconsciousness or a combination of incompetent cognitive impairment and complete aphasia. Take painkillers or other treatments that treat shoulder pain.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruihuan Pan, Doctor
Phone
020-39318381
Email
panruihuan@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Shanshan Ling, Master
Phone
020-39318381
Email
1025283737@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongxia Chen, Master
Organizational Affiliation
Guangdong Provincial Hospital of Traditional Chinese Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial Hospital of Chinese medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongxia Chen, MM
Phone
+8613609031028
Email
chx2004@126.com
First Name & Middle Initial & Last Name & Degree
Shanshan Ling, Master
Phone
+8615626450762
Email
1025286737@qq.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
33308122
Citation
Pan R, Ling S, Yang H, Huang Y, Zhan L, Zhong Y, Chen H. Clinical Study of Qingpeng Ointment Treating Shoulder-hand Syndrome After Cerebral Hemorrhage During the Rehabilitation Period. Comb Chem High Throughput Screen. 2021;24(7):968-975. doi: 10.2174/1386207323666201211093227.
Results Reference
derived

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Clinical Study of Qingpeng Ointment in Treating Shoulder Syndrome During Rehabilitation Period of Cerebral Hemorrhage

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