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CompletedNCT03520595Updated May 15, 2018

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

An interventional study of Arnica 200 drug 3 pills,3 times daily for 3 days and Diclofenac Sodium 50mg twice daily in Crown Lengthening Procedure With Ostectomy, sponsored by Tatyasaheb Kore Dental College. Completed at 1 site in India. Open to participants aged 17 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-15.

Sponsored by Tatyasaheb Kore Dental College · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
17 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Crown Lengthening Procedure With Ostectomy
03

In context

Lead sponsor

Tatyasaheb Kore Dental College is the lead sponsor of 13 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
17 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Arnica Group

    Study group 1 CLP with ostectomy Arnica 200 drug 3 pills,3 times daily for 3 days

    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

    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

    Drug: Placebo pills and distilled water 3 pills,3 times daily

Interventions

  • DrugArnica 200 drug 3 pills,3 times daily for 3 days

    CLP with ostectomy done in patients whose biologic width and crown height is insufficient

    Also known as: CLP with ostectomy

  • DrugDiclofenac Sodium 50mg twice daily

    CLP with ostectomy done in patients whose biologic width and crown height is insufficient

    Also known as: CLP with ostectomy

  • DrugPlacebo pills and distilled water 3 pills,3 times daily

    CLP with ostectomy done in patients whose biologic width and crown height is insufficient

    Also known as: CLP with ostectomy

06

What researchers measure

Primary outcomes

  1. Visual Analog Scale

    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.

    Time frame: 3 days

07

Study locations

1 site
  • Dental
    Kolhapur, Maharashtra 416113, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03520595
Lead sponsor
Tatyasaheb Kore Dental College
Responsible party
Dr.Nibha Suneel Kulkarni (Principal Investigator, Tatyasaheb Kore Dental College) — Principal investigator
First posted
May 11, 2018
Start date
Dec 1, 2016
Primary completion
Jan 31, 2017
Completion
Feb 8, 2017
Last update
May 15, 2018
View the source record on ClinicalTrials.gov ↗

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