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Trial record 15 of 43 for:    herbal medicine AND Chinese | Recruiting, Not yet recruiting, Available Studies

TCM Clinical Practice Rehabilitation of Post-stroke Spasticity

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ClinicalTrials.gov Identifier: NCT03054974
Recruitment Status : Recruiting
First Posted : February 16, 2017
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
JiangFeng, The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
The purpose of this study is to determine the effectiveness,safety and Input-output ratio of chinese traditional treatment in spasm after stroke,both in massage and herbal medicine bathing.

Condition or disease Intervention/treatment Phase
Stroke Other: Modern rehabilitation treatment Other: Modern rehabilitation &TCM Other: modern rehabilitation &Baimai Ruangao Other: modern rehabilitation &Tibetan medicine Not Applicable

Detailed Description:
A Muti-center randomized controlled study with large samples to observe improvement of motor function,severity of spasm,ADL(activity of daily lives),by standardized protocols of TCM techniques(massage and herbal bathing) combined with conventional rehabilitation on spasm after stroke in 1 month.Modified Ashworth scale,Fugl-Meyer Index and Modified barthel Index were used for spasm,motor function and ADL.And also the follow up research within 3 months and 6 months focus on the efficacy duration of TCM on spasm.Try to find suitable timing for intervention on spasm by CTM(Massage and herbal medicine bathing)and the connection between spasm severity and treatment efficacy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Traditional Chinese Medicine Clinical Practice Rehabilitation of Post-stroke Spasticity
Study Start Date : January 2013
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Modern rehabilitation treatment
Modern rehabilitation treatment
Other: Modern rehabilitation treatment
PT 1 hour per day and OT 30min per day

Experimental: Modern rehabilitation &TCM
Modern rehabilitation treatment and traditional Chinese medicine
Other: Modern rehabilitation &TCM
Traditional Chinese Medicine, including massage and medicated bath

Experimental: modern rehabilitation &Baimai Ruangao
modern rehabilitation treatment and Baimai Ruangao
Other: modern rehabilitation &Baimai Ruangao
modern rehabilitation treatment with Baimai Ruangao and massage

Experimental: modern rehabilitation &Tibetan medicine
modern rehabilitation treatment and Tibetan medicine treatment
Other: modern rehabilitation &Tibetan medicine
modern rehabilitation treatment and Tibetan medicine(medicated bath with wuweiganlu and rub with baimairuangao)




Primary Outcome Measures :
  1. Modified Ashworth Scale [ Time Frame: 6 months ]
    the common used clinical measurement to assess the levels of limb spasticity


Secondary Outcome Measures :
  1. Fugl-Meyer Moter Assessment [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Barthel Index [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • According to the diagnostic criteria of stroke and diagnosed by CT or MRI
  • Patient must be between the ages of 18 and 85 years.
  • All patients were examined at least 1 month after stroke and less than 12 months.
  • At least a set of spasmous muscles' level ≥1+ of dysfunctional extremities (modified Ashworth scale)
  • Body movement function decreased significantly.
  • The doses and kinds of anticonvulsant drugs should be used stable for more than 1 month if they are used
  • Patient must understand and be willing, able and likely to comply with all study procedures.
  • Patient must be able to give voluntary written informed consent.

Exclusion Criteria:

  • Significant cognitive defects(MMSE<16),unable to finish the Fugl-Meyer scale,etc..
  • Other significant limb diseases such as fracture, severe arthritis,amputation
  • Joint contracture formation
  • Patients with significant pain and swelling suffering from complex regional syndrome after acute stroke
  • Accept botulinum toxin or alcohol nerve block 3 months prior to the start of the experiment
  • Patients need nerve block at any point of time during the whole experiment procedure.
  • Serious cardiac,hepatic or renal insufficiency and patients with shock.
  • Limb skin of patients who need medicated is visible wound.
  • Patients with cancer or pregnancy
  • Patients who participate in other clinical studies within 6 months

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): NCT03054974


Contacts
Contact: li jianan, Doctor +862583318752 lijianan@carm.org.cn

Locations
China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China, 210029
Contact: Li jianan, Doctor    +862583318752    lijianan@carm.org.cn   
Principal Investigator: Li jianan, Doctor         
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
Study Chair: Li jianan, Doctor The First Affiliated Hospital with Nanjing Medical University

Responsible Party: JiangFeng, JiangFeng Clinical Professor, The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03054974     History of Changes
Other Study ID Numbers: 2013BAI10B04
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by JiangFeng, The First Affiliated Hospital with Nanjing Medical University:
Stroke
Traditional Chinese Medicine
Rehabilitation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases