Effect of Ashwagandha on Salivary Antioxidant and Serum c Reactive Protein in Chronic Generalized Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 1/Phase 2

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.
    

Detailed description: 
      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.

      Special Instructions Given Regarding with Diet to the Patients during Ashwagandha
      supplementation period:-

        1. No Deep Fry Food should be eaten.

        2. No Sour substances.

        3. No Pastry Flour (Maida) made foodstuffs.

      SAMPLE COLLECTION METHOD-

      A ] SALIVA- 2 ml of unstimulated saliva will be collected in a sterile container.
      Centrifugation will be done for 10 minutes at 4000 rpm.16 Then the supernatant will be
      removed and stored at 2oC till the assay procedure.

      Collection of Saliva Sample: Mahvash Navazesh 200817 Unstimulated whole saliva will be
      collected for the estimation of SOD.2ml will be collected from each subject between
      9.00-10.00a.m.The participants will be requested not to eat or drink anything except water in
      the morning before sampling. This will ensure that the variability in salivary flow and
      composition be minimum due to diurnal variation. The subject will be asked to rinse the mouth
      with distilled water thoroughly to remove any food debris.

      B) Serum CRP detection

      Samples:

      Three ml of venous blood were taken from all patients at baseline, after 4 weeks and 8 weeks.

      METHODS OF BIOCHEMICAL ANALYSIS- SOD- Kajridas method C Reactive Protein- hs CRP-
      Nephelometry.

      STATISTICAL ANALYSIS WILL BE DONE BY USING:

      With 95% confidence and 80% power minimum 46 patients from either groups, test as well as
      control group, is required to be included in the study. To compensate for potential dropouts,
      50 patients will be considered, 25 patients constituting in each group.

      Tests will be done are:-

        1. ANOVA repeated measures post hoc.

        2. Independent T test.
    

Intervention name(s): Ashwagandha; Placebo
Intervention type(s): Drug; Other
Intervention description(s): ashwagandha capsules given to the subjects twice daily after meals for 1 month; placebo capsules given twice daily after meals for 1 month
Other intervention name(s): withania somnifera
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment