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Name of the commodity Cheezheng Pain Relieving Plaster
Colour
Specifications 90mm*120mm/Piece,     牋5     牋pieces/Box.
Function or brief introduction
    
Cheezheng Pain Relieving Plaster奇正消痛貼膏

For 10 years by the use of 16 China State Sport Teams, over 2000 medium size hospitals and 35O million customers in China, the Cheezheng pain Reliving Plaster Shows high function on temporarily relieve minor aches and pains of muscles and joints associated with athletic injuries bruises, sprains and strains, rheumatic pains, stiffnecks and shoulders, backaches, muscular fatigues and archritis.

Cheezheng Pain Relieving Plaster (CPRP), refined from pure natural herbs from Qinghai-Tibetan Plateau, is processed under high-tech vacuumed hypothermic and dehydrated conditions. It contains extremely active ingredients as external therapy for promoting blood circulation and removing stasis to effectively relieve pains on acute muscular contusions or injuries within 24 hours. It has also proven efficacy as reliever for chronic pains after 24 hours of application. CPRP has also proven effects as reliever for chronic pains after 24 hours of application. CPRP is formulated as a rectangular medicinal pad based on a hypoallergenic adhesive.
The active ingredients in CPRP include: Phlomis rotate benth, Myricaria germanica (L.), Oxytropis falcate bge.

CLINICAL PHARMACOLOGY

Mechanism of Action: CPRP is a nonsteroidal plaster for external use with composite Tibetan herbal medicines that exhibit anti-inflammatory and analgesic activities in animal models. The mechanism of action of CPRP is believed to be due to the absorption of extremely active herbal ingredients through skin to improve blood circulation by removing blood stasis at the affected areas in accordance to the Chinese medicine therapeutics. CPRP does not contain stimulant and toxic materials. In clinical trial studies, CPRP reduced the swelling parts and multiplicity of inflammatory without causing any side effects that are common in patients treated with orally-taken nonsteriodal anti-inflammatory drugs (NSAIDs) as advanced renal disease, serious gastrointestinal toxicity such as bleeding, ulceration, and perforation of the stomach, small intestine or large intestine.

CLINICAL STUDIES

Osteoarthritis (OA): CPRP has demonstrated significant reduction in joint tenderness/pain and joint swelling compared to placebo. CPRP was evaluated for treatment of the signs and the symptoms of shoulder periarthritis, tennis elbow, hyperosteogency in approximately 60 patients aged 40 and older in placebo- and active-controlled clinical trials of up to 12 weeks duration. In patients with OA, treatment with 1 plaster for acute cases or 5 plasters for chronic cases resulted in improvement in Chinese traditional medicine osteoarthritis index, a composite of pain, stiffness, and functional measures in OA. In two 12-week studies of pain accompanying OA flare, applications of 1 plaster for acute cases or 5 plasters for chronic cases provided significant reduction of pain within 24-48 hours respectively and was shown to be superior to placebo in these studies.
Lumbago: CPRP has demonstrated significant reduction in pains associated with lumbar muscle strain, prolapse of lumbar intervertebral disc and lumbar sprain compared to placebo. CPRP was evaluated for treatment of the signs and symptoms of lumbago in approximately 30 patients in placebo- and active-controlled clinical trials of up to 12 weeks in duration. With applications of 5 plasters by each patient for 5 days provided significant reduction in pains and was shown to be superior to placebo in these studies by using Chinese traditional medicine osteoarthritis index, a composite of clinical, laboratory, and functional measures in lumbago抯 assessment.
Acute and Chronic Soft Tissue Injuries: CPRP was evaluated to reduce the symptoms of pain and swelling. A randomized single-blind placebo-controlled study of 16 weeks in duration was conducted in 4 hospitals in Shanghai in 90 patients with an average age of 44.85 with acute sprains on ankle and other chronic injuries. Results of the study observed the CPRP was statistically superior to placebo after 3 days of treatment to each patient. (See Table 1.)

Table 1
Percent Change of Efficacy after 3 CPRPs?Application
 
Fully Recovered
Significantly Effective
Effective
Not Effective
Rate of Significance
Total Rate of Effectiveness
Controlled
6
51
36
3
63.4%
97.8%
Placebo
0
8
20
2
26.67%
96.66%
Significantly different from placebo p < 0.01.
3 CPRPs for 3 days of application in succession are the recommended doses.

Special Studies

Table 2 summarizes data from 3-day studies that enrolled patients in whom acute sprain injuries revealed symptoms of pain relief by CPRP treatment.
 

Table 2
Comparison of Pain Symptoms of 30 Patients from 3-Day Serial Observation Studies in Acute Sprain Patients

 
Before Treatment
Day 1
Day 2
Day 3

Pain

 
Controlled
2.40 ?.62
1.46 ?.56
1.07 ?.58
0.30 ?.47
Placebo
2.27 ?.69
1.73 ?.58
1.20 ?.61
0.87 ?.57
Press Pain
 
Controlled
2.53 ?.51
2.13 ?.51
1.50 ?.51
0.97 ?.56
Placebo
2.47 ?.51
2.20 ?.71
1.77 ?.68
1.43 ?.63

Swelling

Controlled
2.17 ?.65
2.03 ?.62
1.50 ?.50
0.97 ?.41
Placebo
2.20 ?.66
2.27 ?.65
1.93 ?.58
1.53 ?.68

Recovery of Function

Controlled
2.03 ?.76
1.53 ?.63
1.13 ?.79
0.47 ?.57
Placebo
1.93 ?.83
1.70 ?.84
1.33 ?.68
1.07 ?.78
Significantly different from placebo p < 0.05.

INDICATIONS AND USAGE

CPRP is indicated:
 
1) For relief of the signs and symptoms of rheumatoid arthritis in adults.
 
2) For relief of swelling and inflammatory due to acute and chronic sprains and contusions, athletic injuries, stiff shoulders, muscular fatigue and stress.
 
3)   For relief of osteoarthritis-associated signs and symptoms of arthritis, lumbago, shoulder periarthritis, tennis elbow and hyperosteogency.

CONTRAINDICATIONS

CPRP should not be applied around open wounds and irritated skin.
CPRP should be applied with caution to patients who have demonstrated anaphylactic-like skin reactions to drugs and cosmetics (see WARNINGS and PRECAUTIONS).

WARNINGS

Allergic Reactions

Allergic reactions have occurred in patients without known prior exposure to CPRP. During the controlled clinical trials, it was reported that 10% of patients had exhibited skin allergic reactions such as rash or eruption by using CPRC in comparison to 16.67% in placebo. After suspension of CPRP therapy promptly or receiving appropriate treatment will see this symptom complex faded away. Emergency help should be sought in cases where severe skin irritation occurs.

Pregnancy

In pregnancy CPRP should be used with caution and strictly under a doctor抯 advice.

PRECAUTIONS

General: For external use only. Patients with allergic reactions to drugs or cosmetics should consult a physician before use and appropriately reduce the application hours if applicable. Distilled water can be used in place of the attached diluents to minimize risk of allergic reactions, which will not reduce the efficacy.
Information for Patients
Discontinue use of CPRP if phlyctenule, rashes or eruptions are observed. Patients should promptly report these signs or symptoms to their physicians.
Patients should also be instructed to seek immediate help in the case of severe skin irritation (see WARNINGS).

ADVERSE REACTIONS

In placebo- or active-controlled clinical trials, the discontinuation rate due to adverse events was 2% for patients receiving CPRP and 5% for patients receiving placebo. Among the most common reasons for discontinuation due to adverse events in the CPRP treatment groups was allergic reaction in skin rashes and phlyctenule.  

DOSAGE AND ADMINISTRATION

For symptoms mentioned in Indication and Usage, the lowest dose of CPRP should be one piece for acute injuries and traumatic pains as one treatment period for 24 hours. For chronic casualties, it is recommended that 5 plasters be applied continuously for 5 days as a treatment period. Before application, clean and dry the affected area(s), peel off the protective film and put the diluents contained in the attached plastic tube evenly on the middle of the medicine pad, apply the plaster on the affected area(s) and press the plaster edges lightly.

HOW SUPPLIED

CPRP is wrapped in an independent plastic package for each piece and supplied as:
China SFDA Drug Approval Number
Size
Z54020113
90mmX120mm
Store in a cool and dry place away from direct sunlight.
 
Different package designed supplied to different countries according to the local regulations. For details, please email to intl@qzh.cn.
 
Rx and OTC in China.
 
Formulated by Tibet Cheezheng Tibetan Medicine Co.Ltd., Lab, Tibet, China

Mfd. by Tibet Cheezheng Tibetan Medicine Co.Ltd., Tibet, China

Marketed by International Department, Tibet Cheezheng Tibetan Medicine Co.Ltd.,