A Prospective Cohort Study of Compound Nanxing Zhitong Ointment
1 other identifier
observational
3,000
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the safety and the efficacy of compound Nanxing pain relief cream in the treatment of chronic pain in the musculoskeletal system
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2022
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2021
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedFirst Posted
Study publicly available on registry
January 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2024
CompletedJanuary 21, 2022
January 1, 2022
1 year
December 13, 2021
January 15, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Overall Pain Assessment Scale score at week 12 overall Pain Assessment Scale score at week 12.
Evaluation using Global pain scale, GPS。The change of pain assessment scale score from the beginning period of the treatment to the end indicates the effectiveness of the treatment. The GPS is based on patients' subjective and objective perceptions, and is used to measure patients' overall perceptions of pain. The scores were distributed from 0 to 10, with 0 representing no pain at all and 10 representing the most painful, and the scores were summarized and tallied. Higher scores indicate more severe pain effects.
Change from Baseline GPS at week 12.
Secondary Outcomes (5)
Quality of Life Short Form12,SF-12
Total scores at baseline, week 2, week 4, week 8, and week 12 were evaluated in both groups.
Pain resolution time
VAS is assessed within 1 hour ahead of the treatment and within 1 hour after the treatment. The change of the score indicate the treatment efficacy.
Number of pain-free days per month
Records are taken every day by the end of the day. Records are assessed at the end of 12 weeks of treatment.
Chinese medicine evidence score
The TCM evidence score was assessed within 1 hour after treatment. Changes in TCM evidence scores compared to baseline at week 12.
Safety evaluation
After 12 weeks of treatment, evaluate adverse reactions and make a record.
Eligibility Criteria
1. pain that meets the ICD-11 classification of chronic pain that is localized to the musculoskeletal system and occurs in the neck, shoulder, low back and extremities. 2. Those who meet the criteria of "cold" in Chinese medicine and whose chronic pain is exacerbated by cold. 3. Persistent/intermittent pain for more than 3 months and no indication for surgery.
You may qualify if:
- Attendance at orthopedic, rheumatology and pain clinics for.
You may not qualify if:
- Indication for surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY CHAIR
chen weiheng, M.D.
Vice President of the Third Affiliated Hospital of Beijing University of Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2021
First Posted
January 21, 2022
Study Start
January 1, 2022
Primary Completion
January 1, 2023
Study Completion
January 1, 2024
Last Updated
January 21, 2022
Record last verified: 2022-01