Rheumatic Pain Clinical Trial
| Verified date | March 2017 |
| Source | Chengdu PLA General Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to evaluate the effect of Panax Notoginseng Powders on Rheumatic Pain.
| Status | Enrolling by invitation |
| Enrollment | 80 |
| Est. completion date | December 2018 |
| Est. primary completion date | September 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - had a diagnosis of classic or definite RA - without conflict to the written, informed consent signed prior to the enrollment. Exclusion Criteria: - uncontrolled medical problems - organic brain syndrome - major psychiatric disturbances - major communicative disorders - a history of severe noncompliance - less than 7 years of formal education, or illiteracy - being included in other clinical trial within the last 4 weeks - with abnormal liver or kidney function (more than 1 time above the high normal) - with serious cardiovascular disease - with hematologic disease - being in pregnancy, lactation period or under a pregnancy plan - with severe gastrointestinal disease - with contraindication or being allergic to the test drugs - being under the treatment of drugs within 1 previous week, that might affect the results of the trial, such as non-steroidal anti-inflammatory drugs - being not compatible for the trial medication, or other circumstances at the discretion of investigators - without legal capacity or only with limited legal capacity |
| Country | Name | City | State |
|---|---|---|---|
| China | 270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA, | Chengdu city | Sichuan |
| Lead Sponsor | Collaborator |
|---|---|
| Chengdu PLA General Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from Baseline in McGill Pain Questionnaire (MPQ) score at 24 weeks | This well validated questionnaire assesses pain on several dimensions including sensory pain, affective pain, and evaluative pain. | at 0 week, 6 weeks, 12 weeks, 24 weeks | |
| Primary | Change from Baseline in Visual Analog Scale(VAS) score at 24 weeks | This rating scale involved the selection of a point along a 10-cm line, which described pain intensity on a continuum from "no pain at all" to "pain as bad as it could be." This scale has been found to be an excellent measure of self-reported pain | at 0 week, 6 weeks, 12 weeks, 24 weeks |