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Analgesic Efficacy of Arnica Montana in Comparison With Diclofenac Sodium Following a Periodontal Surgical Procedure

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ClinicalTrials.gov Identifier: NCT03520595
Recruitment Status : Completed
First Posted : May 11, 2018
Last Update Posted : May 15, 2018
Sponsor:
Information provided by (Responsible Party):
Dr.Nibha Suneel Kulkarni, Tatyasaheb Kore Dental College

Tracking Information
First Submitted Date  ICMJE January 31, 2017
First Posted Date  ICMJE May 11, 2018
Last Update Posted Date May 15, 2018
Actual Study Start Date  ICMJE December 1, 2016
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
Visual Analog Scale [ Time Frame: 3 days ]
Pain Assessment is done by visual analog scale which consists of 10 centimeter line. anchored by two extremes starting from 1 ending to 10, of which 1 being the lowest and 10 being highest score.
Original Primary Outcome Measures  ICMJE
 (submitted: April 26, 2018)
Visual Analog Scale [ Time Frame: 3 days ]
Pain Assessment
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgesic Efficacy of Arnica Montana in Comparison With Diclofenac Sodium Following a Periodontal Surgical Procedure
Official Title  ICMJE Analgesic Efficacy of Arnica Montana in Comparison With Diclofenac Sodium Following a Periodontal Surgical Procedure: A Placebo Control Trial
Brief Summary

Introduction:

Homeopathy is a deep healing, comprehensive and distinct system originally developed by Samuel Hahnemann about 200 years ago. Small doses of specially prepared ("potentized") remedies which set the body's systems back in order and stimulate a body's own energies toward a natural healing process. It is entirely distinct in both theory and in practice from other healing systems from ordinary or main-stream ("allopathic") medicine, but also from acupuncture, naturopathy, chiropractics, etc., although some homeopathy often finds its way into these other fields of practice.Homeopathy is based on the concept "similia similibus curentur" which means symptoms, caused by the original substance in healthy subjects, can be reversed by the homeopathic remedy in patients having similar symptoms.Homeopathy has the advantages such as it is inexpensive (the only expense is the homeopath's time and training - the remedies themselves cost practically nothing), non-toxic (although "side affects" which reflect the body's own healing processes may occur - such as fever, discharge, rash, etc.) and non-intrusive (the remedies are carried on tiny sugar granules which are dissolved in water or in the mouth, or swallowed).Arnica is one of the most popular medications in homeopathy medicine. This remedy can be extracted from several plant species belonging to the Aesteraceae family including Arnica montana, Arnica fulgens, Arnica cordifolia, Arnica chamissonis and Arnica sororia, and it is widely sold as tincture, ointment, cream, gel, and tablet. It has been used for the treatment of numerous pathological conditions, including pain, swelling and stiffness associated with trauma, contusions, sprains, myocarditis, angina pectoris, cardiac insufficiency, arteriosclerosis, postoperative clinical conditions, and for symptomatic relief in osteoarthritis.Conventional NSAIDs work by inhibiting cyclooxygenase (COX) and prostaglandin synthesis as well as by other less understood mechanisms. Onset of analgesia occurs rapidly with all NSAIDs, usually within one hour.Diclofenac is one of potent, standard and most unique NSAID for the therapy of postoperative pain. Diclofenac inhibits the lipoxygenase pathways, which reduces the formation of the leukotrienes (also pro-inflammatory autacoids) and also inhibit phospholipase A2. These actions explain the high potency of diclofenac.NSAIDs cause a variety of side effects including nausea, diarrhea, constipation, dizziness, headache, confusion, edema, rash, and pruritis. They can also cause more serious toxicities such as gastrointestinal (GI) ulceration/bleeding, hematologic disturbances, bronchospasm, angioedema, renal dysfunction, and hepatotoxicity. Many of these side effects are due to NSAID inhibiting prostaglandin synthesis other than at the desired site of action.Arnica being clinical efficient and high tolerable makes it a potential therapeutic alternative target to non-steroidal anti-inflammatory drugs.In this study investigator will compare and evaluate the efficacy of Arnica as a substitute for analgesics such as Diclofenac Sodium, through which side effects of NSAIDS can be avoided and get the same analgesia effect through Arnica without any of the undesirable effects for minor surgical procedures.

AIM:

To compare and evaluate the analgesic effect of Arnica Montana with Diclofenac sodium after crown lengthening procedure with ostectomy.

Objectives:

To assess the analgesic effect on crown lengthening procedure with ostectomy patients of Arnica Montana and Diclofenac Sodium.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Crown Lengthening Procedure With Ostectomy
Intervention  ICMJE
  • Drug: Arnica 200 drug 3 pills,3 times daily for 3 days
    CLP with ostectomy done in patients whose biologic width and crown height is insufficient
    Other Name: CLP with ostectomy
  • Drug: Diclofenac Sodium 50mg twice daily
    CLP with ostectomy done in patients whose biologic width and crown height is insufficient
    Other Name: CLP with ostectomy
  • Drug: Placebo pills and distilled water 3 pills,3 times daily
    CLP with ostectomy done in patients whose biologic width and crown height is insufficient
    Other Name: CLP with ostectomy
Study Arms  ICMJE
  • Active Comparator: Arnica Group
    Study group 1 CLP with ostectomy Arnica 200 drug 3 pills,3 times daily for 3 days
    Intervention: Drug: Arnica 200 drug 3 pills,3 times daily for 3 days
  • Active Comparator: Diclofenac Sodium group
    Study group 2 CLP with ostectomy Diclofenac Sodium 50mg twice daily after meals with plain water
    Intervention: Drug: Diclofenac Sodium 50mg twice daily
  • Placebo Comparator: Placebo Group
    Study group 3 CLP with ostectomy Placebo pills and distilled water 3 pills,3 times daily
    Intervention: Drug: Placebo pills and distilled water 3 pills,3 times daily
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2018)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 8, 2017
Actual Primary Completion Date January 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Systemically healthy patients.
  • Patients with inadequate crown height for replacement for prosthesis.

Exclusion Criteria:

  • Tobacco intake in any form and alcohol.
  • Pregnant & lactating women.
  • Any known/reported allergy to given drugs.
  • On Antibiotics medications.
  • Patient with the history of acidity ,gastric disorders.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 17 Years to 55 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03520595
Other Study ID Numbers  ICMJE Tatyasaheb kore dental c
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr.Nibha Suneel Kulkarni, Tatyasaheb Kore Dental College
Study Sponsor  ICMJE Tatyasaheb Kore Dental College
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tatyasaheb Kore Dental College
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP