The Effect of Panax Notoginseng Powders on Rheumatic Pain

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effect of Panax Notoginseng Powders on Rheumatic Pain.

Conditions
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Rheumatic Pain

Intervention / Treatment
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* Dietary Supplement: Panax Notoginseng Powder 1g
* Dietary Supplement: Panax Notoginseng Powder 5g
* Dietary Supplement: Panax Notoginseng Powder 10g
* Dietary Supplement: Panax Notoginseng Powder 15g
* Drug: Celecoxib Capsule 400 mg daily


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Panax Notoginseng Powder 1g<br>Panax Notoginseng Powder 1g, daily | Dietary Supplement: Panax Notoginseng Powder 1g<br> <br> |
| Experimental: Panax Notoginseng Powder 5g<br>Panax Notoginseng Powder 5g,daily | Dietary Supplement: Panax Notoginseng Powder 5g<br> <br> |
| Experimental: Panax Notoginseng Powder 10g<br>Panax Notoginseng Powder 10g,daily | Dietary Supplement: Panax Notoginseng Powder 10g<br> <br> |
| Experimental: Panax Notoginseng Powder 15g<br>Panax Notoginseng Powder 15g,daily | Dietary Supplement: Panax Notoginseng Powder 15g<br> <br> |
| Active Comparator: Celecoxib Capsule 400 mg daily<br>Celecoxib Capsule 400 mg daily | Drug: Celecoxib Capsule 400 mg daily<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |