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Effect of Ashwagandha on Salivary Antioxidant and Serum c Reactive Protein in Chronic Generalized Periodontitis

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ClinicalTrials.gov Identifier: NCT03533972
Recruitment Status : Completed
First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Dr.Nibha Suneel Kulkarni, Tatyasaheb Kore Dental College

Brief Summary:
Periodontal disease is an immune-inflammatory disease which consists of connective tissue breakdown, loss of attachment, and alveolar bone loss.In normal physiology, there is an equilibrium maintained between reactive oxygen species (ROS) activity and antioxidant defence capacity. when this equilibrium changes and shifts in favour of ROS, it will result in oxidative stress (OS). Increased levels of acute phase proteins have been associated with gingival inflammation and periodontitis, which reflected the locally stressed environment. it has been well established that in chronic inflammation sites there is over-production of ROS. The human body consists of an array of antioxidant defense mechanisms (non-enzymatic and enzymatic antioxidants) which removes harmful ROS as soon as they are formed and prevent their deleterious effects. Superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase are the enzymatic antioxidants, while the nonenzymatic antioxidants include vitamins E and C, and reduced glutathione. C - reactive protein (CRP) is a plasma protein that reflects a measure of the acute phase response to inflammation and is one of the markers of choice in monitoring this response. Changes in peripheral blood cellular and molecular components can be seen in patients with periodontitis, as periodontitis includes inflammatory changes of the periodontal tissues. Ashwagandha is also known as Indian ginseng and winter cherry. It consists of dried roots of Withania Somnifera (Family: Solanaceae).6 The Sanskrit words ashva meaning horse, and gandha meaning smell together form the name Ashwagandha. Ashwagandha possessed marked anti-inflammatory effect against denaturation of protein in vitro. the effect was plausibly due to the alkaloid and withanolide contents of ashwagandha. It is a multipurpose herb, which acts as adaptogenic, antioxidant, anticancer, anxiolytic, antidepressant, cardio protective, thyroid modulating, immunomodulating, antibacterial, anti-inflammatory, neuroprotective, cognitive enhancing and hematopoietic agent.So, this study is carried out to assess SOD & CRP levels with or without Ashwagandha supplementation as an adjunct to scaling and root planing(SRP) in chronic periodontitis(CP) patients.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: Ashwagandha Other: Placebo Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Ashwagandha (Withania Somnifera) as an Adjunct to Scaling and Root Planing on Salivary Antioxidant and Serum c Reactive Protein Levels in Chronic Generalized Periodontitis- a Randomized Double Blind Clinico-biochemical Trial
Actual Study Start Date : November 30, 2017
Actual Primary Completion Date : February 27, 2018
Actual Study Completion Date : April 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arm Intervention/treatment
Experimental: Test group
subjects will be provided with Ashwagandha capsules 500 mg twice daily, after meals with plain water for 1 month
Drug: Ashwagandha
ashwagandha capsules given to the subjects twice daily after meals for 1 month
Other Name: withania somnifera

Placebo Comparator: Control group
subjects will be provided with placebo capsules.
Other: Placebo
placebo capsules given twice daily after meals for 1 month




Primary Outcome Measures :
  1. change in c reactive protein [ Time Frame: 1 month and 2 months ]
    c reactive protein levels by nephelometry

  2. change in super oxide dismutase [ Time Frame: 1 month and 2 months ]
    super oxide dismutase levels by biochemical kazaridas method

  3. change in probing depth [ Time Frame: 1 month and 2 months ]
    measured with UNC 15 Probe

  4. change in clinical attachment loss [ Time Frame: 1 month and 2 months ]
    measured with UNC 15 probe


Secondary Outcome Measures :
  1. gingival index [ Time Frame: 1 month and 2 months ]
    clinically assessed its a scale ranging from 0 to 3,in which 0 being the least and 3 being the highest



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Ages Eligible for Study:   17 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients without any known systemic diseases.
  • Patients with chronic generalized periodontitis based on CDC 2007

Exclusion Criteria:

  • Patients who have taken anti-inflammatory/antibiotic/antioxidant within 3 months of beginning of study.
  • Subjects who have undergone periodontal treatment within 6 months of inception of study.
  • Tobacco habits in any form and alcoholics.
  • Pregnant and lactating women.
  • Patients on anti-depressant, thyroid, anti- psychiatric, diabetic medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03533972


Locations
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India
Tatyasaheb Kore Dental College
Kolhapur, Maharashtra, India, 416113
Sponsors and Collaborators
Tatyasaheb Kore Dental College

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Responsible Party: Dr.Nibha Suneel Kulkarni, Principal Investigator, Tatyasaheb Kore Dental College
ClinicalTrials.gov Identifier: NCT03533972     History of Changes
Other Study ID Numbers: nibhask
First Posted: May 23, 2018    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs