The Effect of Panax Notoginseng Powders on Rheumatic Pain

Chengdu PLA General Hospital

Status: Unknown

Conditions: Rheumatic Pain

Treatments: Dietary Supplement: Panax Notoginseng Powder 10g; Dietary Supplement: Panax Notoginseng Powder 5g; Dietary Supplement: Panax Notoginseng Powder 1g; Drug: Celecoxib Capsule 400 mg daily; Dietary Supplement: Panax Notoginseng Powder 15g

Study type: Interventional

Funder types: Other

Identifiers

NCT02260336

PNP01RP001

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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80 participants in 5 patient groups

Panax Notoginseng Powder 1g

Experimental group

Description:

Panax Notoginseng Powder 1g, daily

Treatment:

Dietary Supplement: Panax Notoginseng Powder 1g

Panax Notoginseng Powder 5g

Experimental group

Description:

Panax Notoginseng Powder 5g,daily

Treatment:

Dietary Supplement: Panax Notoginseng Powder 5g

Panax Notoginseng Powder 10g

Experimental group

Description:

Panax Notoginseng Powder 10g,daily

Treatment:

Dietary Supplement: Panax Notoginseng Powder 10g

Panax Notoginseng Powder 15g

Experimental group

Description:

Panax Notoginseng Powder 15g,daily

Treatment:

Dietary Supplement: Panax Notoginseng Powder 15g

Celecoxib Capsule 400 mg daily

Active Comparator group

Description:

Celecoxib Capsule 400 mg daily

Treatment:

Drug: Celecoxib Capsule 400 mg daily