Clinical trial NCT04039737: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: The Efficacy of Qingpeng Ointment
Keywords: Qingpeng Ointment
Shoulder Syndrome
Rehabilitation Period of Cerebral Hemorrhage
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Painful degree change of ipsilateral shoulder
timeFrame: VAS will be tested before treatment and after a 4-week treatment so as to compare the efficacy.Twice in total
measure: Motor function change
timeFrame: This scale will be tested before treatment and after a 4-week treatment so as to compare the efficacy.Twice in total
measure: Activity of daily living change (ADL)
timeFrame: This scale will be tested before treatment and after a 4-week treatment so as to compare the efficacy.Twice in total
measure: Shoulder joint mobility change
timeFrame: These will be tested before treatment and after a 4-week treatment so as to compare the efficacy.Twice in total
Secondary outcomes:
measure: Safety evaluation
timeFrame: After 4 weeks of treatment, evaluate adverse reactions and make a record.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese medicine
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Hongxia Chen, Master
role: PRINCIPAL_INVESTIGATOR
References:
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.