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The Effect of Panax Notoginseng Powders on Rheumatic Pain

Primary Purpose

Rheumatic Pain

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Panax Notoginseng Powder 1g
Panax Notoginseng Powder 5g
Panax Notoginseng Powder 10g
Panax Notoginseng Powder 15g
Celecoxib Capsule 400 mg daily
Sponsored by
Chengdu PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatic Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA，

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Panax Notoginseng Powder 1g

Panax Notoginseng Powder 5g

Panax Notoginseng Powder 10g

Panax Notoginseng Powder 15g

Celecoxib Capsule 400 mg daily

Arm Description

Panax Notoginseng Powder 1g, daily

Panax Notoginseng Powder 5g,daily

Panax Notoginseng Powder 10g,daily

Panax Notoginseng Powder 15g,daily

Celecoxib Capsule 400 mg daily

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Full Information

First Posted
October 3, 2014
Last Updated
March 31, 2017
Sponsor
Chengdu PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02260336
Brief Title
The Effect of Panax Notoginseng Powders on Rheumatic Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chengdu PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Panax Notoginseng Powder 1g
Arm Type
Experimental
Arm Description
Panax Notoginseng Powder 1g, daily
Arm Title
Panax Notoginseng Powder 5g
Arm Type
Experimental
Arm Description
Panax Notoginseng Powder 5g,daily
Arm Title
Panax Notoginseng Powder 10g
Arm Type
Experimental
Arm Description
Panax Notoginseng Powder 10g,daily
Arm Title
Panax Notoginseng Powder 15g
Arm Type
Experimental
Arm Description
Panax Notoginseng Powder 15g,daily
Arm Title
Celecoxib Capsule 400 mg daily
Arm Type
Active Comparator
Arm Description
Celecoxib Capsule 400 mg daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Panax Notoginseng Powder 1g
Intervention Type
Dietary Supplement
Intervention Name(s)
Panax Notoginseng Powder 5g
Intervention Type
Dietary Supplement
Intervention Name(s)
Panax Notoginseng Powder 10g
Intervention Type
Dietary Supplement
Intervention Name(s)
Panax Notoginseng Powder 15g
Intervention Type
Drug
Intervention Name(s)
Celecoxib Capsule 400 mg daily
Primary Outcome Measure Information:
Title
Change from Baseline in McGill Pain Questionnaire (MPQ) score at 24 weeks
Description
This well validated questionnaire assesses pain on several dimensions including sensory pain, affective pain, and evaluative pain.
Time Frame
at 0 week, 6 weeks, 12 weeks, 24 weeks
Title
Change from Baseline in Visual Analog Scale(VAS) score at 24 weeks
Description
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
Time Frame
at 0 week, 6 weeks, 12 weeks, 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA，
City
Chengdu city
State/Province
Sichuan
ZIP/Postal Code
610083
Country
China

12. IPD Sharing Statement

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The Effect of Panax Notoginseng Powders on Rheumatic Pain

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