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

NCT03533972 | Completed Phase 1

• 1 other identifier: nibhask
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (4)

• change in c reactive protein

  c reactive protein levels by nephelometry

  1 month and 2 months

• change in super oxide dismutase

  super oxide dismutase levels by biochemical kazaridas method

  1 month and 2 months

• change in probing depth

  measured with UNC 15 Probe

  1 month and 2 months

• change in clinical attachment loss

  measured with UNC 15 probe

  1 month and 2 months

Secondary Outcomes (1)

• gingival index

  1 month and 2 months

Study Arms (2)

Test group

EXPERIMENTAL

subjects will be provided with Ashwagandha capsules 500 mg twice daily, after meals with plain water for 1 month

Drug: Ashwagandha

Control group

PLACEBO COMPARATOR

subjects will be provided with placebo capsules.

Other: Placebo

Interventions

Ashwagandha DRUG

ashwagandha capsules given to the subjects twice daily after meals for 1 month

Also known as: withania somnifera

Test group

Placebo OTHER

placebo capsules given twice daily after meals for 1 month

Control group

Eligibility Criteria

• Age: 17 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tatyasaheb Kore Dental College: lead

Study Sites (1)

Tatyasaheb Kore Dental College

Kolhāpur, Maharashtra, 416113, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Ashwagandha

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2018
• First Posted: May 23, 2018
• Study Start: November 30, 2017
• Primary Completion: February 27, 2018
• Study Completion: April 28, 2018
• Last Updated: May 23, 2018

Record last verified: 2018-05

Locations

IN (1)