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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04039737
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Guangzhou University of Traditional Chinese Medicine

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.

Condition or disease Intervention/treatment Phase
The Efficacy of Qingpeng Ointment Drug: Qingpeng Ointment Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of Qingpeng Ointment in Treating Shoulder Syndrome During Rehabilitation Period of Cerebral Hemorrhage
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment Group
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.
Drug: Qingpeng Ointment
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.

No Intervention: Control Group



Primary Outcome Measures :
  1. Painful degree change of ipsilateral shoulder [ Time Frame: VAS will be tested before treatment and after a 4-week treatment so as to compare the efficacy.Twice 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.

  2. Motor function change [ Time Frame: This scale will be tested before treatment and after a 4-week treatment so as to compare the efficacy.Twice in total ]
    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.

  3. Activity of daily living change (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 ]
    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.

  4. Shoulder joint mobility change [ Time Frame: These will be tested before treatment and after a 4-week treatment so as to compare the efficacy.Twice in total ]
    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 :
  1. Safety evaluation [ Time Frame: After 4 weeks of treatment, evaluate adverse reactions and make a record. ]
    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".



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04039737


Contacts
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Contact: Ruihuan Pan, Doctor 020-39318381 panruihuan@126.com
Contact: Shanshan Ling, Master 020-39318381 1025283737@qq.com

Locations
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China, Guangdong
Guangdong Provincial Hospital of Chinese medicine Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Hongxia Chen, MM    +8613609031028    chx2004@126.com   
Contact: Shanshan Ling, Master    +8615626450762    1025286737@qq.com   
Sponsors and Collaborators
Guangzhou University of Traditional Chinese Medicine
Investigators
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Principal Investigator: Hongxia Chen, Master Guangdong Provincial Hospital of Traditional Chinese Medicine
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Responsible Party: Guangzhou University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT04039737    
Other Study ID Numbers: JDZX2015224
First Posted: July 31, 2019    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guangzhou University of Traditional Chinese Medicine:
Qingpeng Ointment
Shoulder Syndrome
Rehabilitation Period of Cerebral Hemorrhage
Additional relevant MeSH terms:
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Cerebral Hemorrhage
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases