Anti Inflammatory and Analgesic Effect of Ginger Powder in Dental Pain Model (GPE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Qazvin University Of Medical Sciences.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
farshid rayati, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01429935
First received: September 4, 2011
Last updated: September 6, 2011
Last verified: September 2011
  Purpose

Ginger contains constituents with pharmacological properties similar to the novel class of dual-acting NSAIDs. Compounds in this class inhibit arachidonic acid metabolism via the cyclooxygenase (COX) and lipooxygenase (LOX) pathways. These compounds have notably fewer side effects than conventional NSAIDs and now are being investigated as a novel class of anti-inflammatory compounds. Although ginger has potentially strong anti-inflammatory components, its efficacy on acute inflammation was not assessed before. The common postoperative sequelae of surgical removal of impacted teeth are pain, trismus and swelling, related to local inflammatory reaction, with cyclooxygenase and prostaglandins playing a crucial role. NSAIDs (e.g. Ibuprofen) are effective in the management of postoperative dental pain, likely through blockage of prostaglandin synthesis and are commonly used. The efficacy of Ibuprofen in the treatment of postoperative dental pain has been evaluated in several clinical trials. However, NSAIDs are contraindicated in patients with gastrointestinal ulcers, bleeding disorders, and renal dysfunctions. Therefore, there is a need for an effective, oral analgesic with a more favorable safety profile. The primary aim of this study was to investigate the ability of Ginger powder (Zintoma, Goldaru) to reduce postoperative swelling, pain and trismus in an acute pain model.


Condition Intervention Phase
Impacted Third Molar Tooth
Drug: Ginger powder
Drug: Ibuprofen
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of The Anti Inflammatory and Analgesic Effect of Ginger and Ibuprofen in Post Surgical Pain Model; a Randomized,Placebo-controlled,Double-blind Clinical Trial

Resource links provided by NLM:


Further study details as provided by Qazvin University Of Medical Sciences:

Primary Outcome Measures:
  • Decreased amount of cheek swelling after surgery [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Using standard calipers, cheek thickness will be measured from the lingual aspect of the mid-portion of the crown of the mandibular 1st molar (on the same side) to the tangent of the skin of the cheek.


Secondary Outcome Measures:
  • Decreased amount of serum CRP levels [ Time Frame: 3 days ] [ Designated as safety issue: No ]
    A venous blood sample (approximately 4 ml, 2ml for CBC check up and 2 ml for CRP concentration) will be collected to quantitatively assess the CRP concentration after surgery and the second sample will be collected 72 hours postoperatively

  • Amount of pain severity [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    using 100mmVAS scale,at 1 hour intervals in the first 12 hours following the surgery and every 6 hours until day 5.

  • Increased amount of Mouth opening ability [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    assessed by measuring the distance between the upper and lower central incisal edges at maximal mouth opening on days 0 (baseline) and 1,3 and 5 post operatively.


Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: October 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ginger powder Drug: Ginger powder
capsules contain 500mg Ginger powder,every 6hours,for 5 days
Other Name: zintoma
Active Comparator: Ibuprofen
capsules of Ibuprofen 400 mg
Drug: Ibuprofen
capsules of Ibuprofen 400 mg, every 6 hours for 5 days
Placebo Comparator: placebo
capsules contain starch
Other: placebo
capsules contain starch

Detailed Description:

Ginger, the rhizome of Zingiber officinale, has a long history of medicinal use. In traditional Chinese and Indian medicine, ginger has been used to treat a wide range of ailments including stomachache, diarrhea, nausea, asthma, respiratory disorders, toothache, gingivitis, and arthritis. Subsequent studies revealed that ginger contains constituents with pharmacological properties similar to the novel class of dual-acting NSAIDs. Compounds in this class inhibit arachidonic acid metabolism via the cyclooxygenase (COX) and lipooxygenase (LOX) pathways. These compounds have notably fewer side effects than conventional NSAIDs and now are being investigated as a novel class of anti-inflammatory compounds. Different animal studies revealed that oral dried ginger or ginger extract reduced inflammation in paw and joint swelling induced by different chemical agents, lung inflammation induced by lipopolysaccharides (LPS) and arthritis induced by collagen . Several clinical studies support the value of ginger for the treatment of osteoarthritis . In addition to alleviating pain, ginger extract has been reported to decrease joint swelling. In some of these trials it was reported that ginger relieved pain and swelling to varying degrees in patients with osteoarthritis and rheumatoid arthritis as well as those with muscular pain without causing any adverse effects during a period ranging from 3 months to 2.5 years . In one recent trial ginger was tested in primary dysmenorrhea in comparison with Ibuprofen and mefenamic acid and no significant differences was found between the three study groups in relief, stability, or aggravation of symptoms . The common postoperative sequelae of surgical removal of impacted teeth are pain, trismus and swelling, related to local inflammatory reaction, with cyclooxygenase and prostaglandins playing a crucial role. NSAIDs (e.g. Ibuprofen) are effective in the management of postoperative dental pain, likely through blockage of prostaglandin synthesis and are commonly used. The efficacy of Ibuprofen in the treatment of postoperative dental pain has been evaluated in several clinical trials . However, NSAIDs are contraindicated in patients with gastrointestinal ulcers, bleeding disorders, and renal dysfunctions. Therefore, there is a need for an effective, oral analgesic with a more favorable safety profile. The primary aim of this study was to investigate the ability of Ginger powder (Zintoma, Goldaru,Iran) to reduce postoperative swelling, pain and trismus after third molar surgery.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have at least one mesio-angular impacted mandibular third molar(5-7 difficulty degree)
  • adults without any kind of systemic disease
  • adults with at least Diploma educational degree

Exclusion Criteria:

  • history of cold,fever,infection or any other inflammatory conditions during one month before surgery
  • known allergy to NSAIDs ,ginger or acetaminophen
  • any kind of hematopoietic or bleeding disorders
  • pregnancy or lactating
  • history of peptic ulceration
  • history of corticosteroid use
  • duration of surgery more than 30 minutes
  • any infection, fever or any kind of disease cause on days 1,2 and 3 after surgery
  • failure to attend for follow up
  • using any kind of medication other than given drugs until day 5 post operatively
  • being on anticoagulants except for mini-aspirin (72-325 mg/day)
  • mentally incapable of understanding or complying with the study protocol or for failing to sign the informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01429935

Locations
Iran, Islamic Republic of
Qazvin University of Medical Sciences
Qazvin, Qazvin State, Iran, Islamic Republic of, 3415759811
University of Medical Science
Qazvin, Iran, Islamic Republic of
Sponsors and Collaborators
Qazvin University Of Medical Sciences
Investigators
Study Chair: Farshid Rayati, DDS,OMFS Assisstant professor of oral and maxillofacial dapartment
Study Director: Fateme Hajmanuchehri Assisstant professor of general pathology department
Study Director: Mehran Purghasemi General pharmacologist
Study Director: Elnaz Najafi, DDS General dentist
Principal Investigator: Farshid Rayati, DDS,OMFS Assisstant professor of oral and maxillofacial department
Principal Investigator: Elanaz Najafi, dentist General dentist
  More Information

No publications provided

Responsible Party: farshid rayati, assisstant proffessor of oral and maxillofacial department, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT01429935     History of Changes
Other Study ID Numbers: 504
Study First Received: September 4, 2011
Last Updated: September 6, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Qazvin University Of Medical Sciences:
dental pain model
Ginger powder
CRP

Additional relevant MeSH terms:
Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases
Ibuprofen
Analgesics
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 16, 2014