The Effect of Panax Notoginseng Powders on Rheumatic Pain

March 31, 2017 updated by: Yang Min, Chengdu PLA General Hospital
The purpose of this study is to evaluate the effect of Panax Notoginseng Powders on Rheumatic Pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu city, Sichuan, China, 610083
        • 270 Rongdu street, Jin-niu district,Rheumatology Center of Integrated Medicine, General Hospital of Chengdu Military Area Command PLA，

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Panax Notoginseng Powder 1g
Panax Notoginseng Powder 1g, daily
Dietary supplement: Panax Notoginseng Powder 1g
Experimental: Panax Notoginseng Powder 5g
Panax Notoginseng Powder 5g,daily
Dietary supplement: Panax Notoginseng Powder 5g
Experimental: Panax Notoginseng Powder 10g
Panax Notoginseng Powder 10g,daily
Dietary supplement: Panax Notoginseng Powder 10g
Experimental: Panax Notoginseng Powder 15g
Panax Notoginseng Powder 15g,daily
Dietary supplement: Panax Notoginseng Powder 15g
Active Comparator: Celecoxib Capsule 400 mg daily
Drug: Celecoxib Capsule 400 mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in McGill Pain Questionnaire (MPQ) score at 24 weeks
Time Frame: at 0 week, 6 weeks, 12 weeks, 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
Time Frame: at 0 week, 6 weeks, 12 weeks, 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

October 3, 2014

First Submitted That Met QC Criteria

October 6, 2014

First Posted (Estimate)

October 9, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 31, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PNP01RP001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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