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临床试验/NCT03533972
NCT03533972已完成1 期

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

Tatyasaheb Kore Dental College1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年11月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
50
试验地点
1
主要终点
change in clinical attachment loss

研究概览

简要总结

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.

详细描述

Periodontal disease is an immune-inflammatory disease which consists of connective tissue breakdown, loss of attachment, and alveolar bone loss.1 In normal physiology, there is an equilibrium maintained between reactive oxygen species (ROS) activity and antioxidant defence capacity. Thus when this equilibrium changes and shifts in favour of ROS, it will result in oxidative stress (OS). OS plays a causative role in pathogenesis of periodontal disease.2 Increased levels of acute phase proteins have been associated with gingival inflammation and periodontitis, which reflected the locally stressed environment.3 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.2 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. CRP can be used for the prediction and early detection of periodontal disease as it is a sensitive marker to evaluate the inflammatory status.4 Ayurveda is the traditional system of medicine practiced in India that can be traced back to 6000 BC .It is a basic foundation of ancient medical science in India. 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. The root has been described as having a strong "horse like" aroma, although some experts note that the origin of the name suggests that one who ingests it can attain the strength and vitality of a horse.7 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.6 Ashwagandha root has major bioactive constituents which are steroidal alkaloids and lactones known as withanolides which have immunomodulatory effect.8 It is a multipurpose herb, which acts as adaptogenic, antioxidant, anticancer, anxiolytic, antidepressant, cardio protective, thyroid modulating, immunomodulating, antibacterial, antifungal, anti-inflammatory, neuroprotective, cognitive enhancing and hematopoietic agent.7 Also, by taking Ashwagandha regularly one can enhance his memory and learning skills dramatically.9So, 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.

MATERIALS AND METHODS

The study will be a randomized double-blind clinical and biochemical trial in which 50 subjects with CP in the age group of 30-55 years, reporting to Department of Periodontology, TKDC and RC, New Pargaon will be equally and randomly divided into Test Group (TG) and Control Group (CG). The randomization will be done based on consort guidelines 2010 14

TG will be provided with Ashwagandha capsules 500 mg twice daily, after meals with plain water for 1 month and CG will be provided with placebo. SRP will be done at baseline in TG and CG. Clinical and biochemical parameters will be recorded at baseline, 1st month (4 weeks) and 2nd month (8 weeks). Whole saliva sample (unstimulated) will be collected. Recall visits will be carried out on 4th week and 8th week. Oral hygiene instructions and reinforcement will be carried out.

Questionnaire will be provided to both the groups for evaluation. All participants will be explained the need and design of the study and written consent will be obtained from each individual prior to the commencement of the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
17 Years 至 55 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

Test group

Experimental

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

干预措施: Ashwagandha (Drug)

Control group

Placebo Comparator

subjects will be provided with placebo capsules.

干预措施: Placebo (Other)

结局指标

主要结局

change in clinical attachment loss

时间窗: 1 month and 2 months

measured with UNC 15 probe

change in super oxide dismutase

时间窗: 1 month and 2 months

super oxide dismutase levels by biochemical kazaridas method

change in probing depth

时间窗: 1 month and 2 months

measured with UNC 15 Probe

change in c reactive protein

时间窗: 1 month and 2 months

c reactive protein levels by nephelometry

次要结局

  • gingival index(1 month and 2 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr.Nibha Suneel Kulkarni

Principal Investigator

Tatyasaheb Kore Dental College

研究点 (1)

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