- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03533972
Effect of Ashwagandha on Salivary Antioxidant and Serum c Reactive Protein in Chronic Generalized Periodontitis
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
Study Overview
Status
Conditions
Intervention / Treatment
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:-
- No Deep Fry Food should be eaten.
- No Sour substances.
- 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:-
- ANOVA repeated measures post hoc.
- Independent T test.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Maharashtra
-
Kolhapur, Maharashtra, India, 416113
- Tatyasaheb Kore Dental College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / 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
|
ashwagandha capsules given to the subjects twice daily after meals for 1 month
Other Names:
|
Placebo Comparator: Control group
subjects will be provided with placebo capsules.
|
placebo capsules given twice daily after meals for 1 month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in c reactive protein
Time Frame: 1 month and 2 months
|
c reactive protein levels by nephelometry
|
1 month and 2 months
|
change in super oxide dismutase
Time Frame: 1 month and 2 months
|
super oxide dismutase levels by biochemical kazaridas method
|
1 month and 2 months
|
change in probing depth
Time Frame: 1 month and 2 months
|
measured with UNC 15 Probe
|
1 month and 2 months
|
change in clinical attachment loss
Time Frame: 1 month and 2 months
|
measured with UNC 15 probe
|
1 month and 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 month and 2 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- nibhask
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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