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

subjects will be provided with placebo capsules.

Chronic Periodontitis

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

Ashwagandha

placebo capsules given twice daily after meals for 1 month

Placebo

Tatyasaheb Kore Dental College

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

c reactive protein levels by nephelometry

super oxide dismutase levels by biochemical kazaridas method

clinically assessed its a scale ranging from 0 to 3,in which 0 being the least and 3 being the highest

Dr.Nibha Suneel Kulkarni

Principal Investigator

Sensoril® is a proprietary extract of Withania Somnifera

Sensoril® is a proprietary extract of Withania Somnifera
Sensoril®: Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera

Sensoril®

Placebo
Placebo: Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.

Total

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

Diagnosis Schizophrenia or Schizoaffective

Number of lifetime psychiatric hospitalizations

Age at onset of 1st episode

Current Smokers

The Positive and Negative Syndrome Scale (PANSS) measures symptom severity in patients with psychotic illnesses. It yields a total score as well as subscores for Positive symptoms, Negative symptoms and General symptoms.
PANSS Positive subscale consists of 7 Items - (minimum score = 7, maximum score = 49) - Higher values represent a worse outcome.
PANSS Negative subscale consists of 7 Items - (minimum score = 7, maximum score = 49) - Higher values represent a worse outcome.
General Psychopathology subscale consists of 16 items - (minimum score = 16, maximum score = 112) - Higher values represent a worse outcome.
PANSS Total Score - The 3 subscales scores are summed to compute a PANSS Total score. The minimum PANSS total score = 30, maximum = 210 - Higher values represent a worse outcome

Positive and Negative Syndrome Scale (PANSS)

The Perceived Stress Scale (PSS) was developed to measure the degree to which situations in one's life are appraised as stressful.
Perceived Stress Scale Scoring Each item is rated on a 5-point scale ranging from never (0) to very often (4). Positively worded items are reverse scored, and the ratings are summed, with higher scores indicating more perceived stress.
PSS-10 scores are obtained by reversing the scores on the four positive items:
For example, 0=4, 1=3, 2=2, etc. and then summing across all 10 items. Items 4, 5, 7, and 8 are the positively stated items. Total score can range from 0 to 40. Scores around 13 are considered average. Scores of 20 or higher are considered high stress,

Perceived Stress Scale (PSS)

The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Possible ratings are: 0 = not assessed, 1 = Normal, not at all ill, 2 = Borderline mentally ill, 3 = Mildly ill, 4 = Moderately ill, 5 = Markedly ill, 6 = Severely ill, 7 = Among the most extremely ill patients - The higher the score the worse outcome

Clinical Global Impression Scale (CGI-S) - Severity

The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as: Possible ratings are: 1= Very much improved, 2=Much improved, 3=Minimally improved, 4=No change, 5= Minimally worse, 6= Much worse, 7=Very much worse.
The higher the score the worse outcome

Number of Participants With a Score of 1, 2, or 3 on the Clinical Global Impression Improvement Scale

Changes in immune marker IL-2 will be assessed in response to study medication.

Immune Marker IL-2

Changes in immune marker IL-4 will be assessed in response to study medication.

Immune Marker IL-4

Changes in immune marker IL-6 will be assessed in response to study medication.

Immune Marker IL-6

Changes in immune marker IFN-Y (gamma) will be assessed in response to study medication.

Immune Marker IFN-Y (Gamma)

Changes in immune marker hs-CRP (high sensitivity C Reactive Protein) will be assessed in response to study medication.
hsCRP - mg/L

Immune Marker Hs-CRP (High Sensitivity C Reactive Protein)

Changes in immune marker S-100B will be assessed in response to study medication.
Elisa
Sensitivity 2.7 picogm/ml
Range 2.7 to 2000 picogm/ml

Immune Marker S-100B

Clinically significant changes in weight will be assessed for "normal" or "abnormal" following randomization to 12 weeks or end of study

Vital Signs - Weight

Clinically significant changes in BMI will be assessed for "normal" or "abnormal" following randomization to 12 weeks or end of study.

Vital Signs - Body Mass Index

Clinically significant changes in BP will be assessed for "normal" or "abnormal" following randomization to 12 weeks or end of study.

Vital Signs - Blood Pressure Systolic and Diastolic

Clinically significant changes in Pulse will be assessed for "normal" or "abnormal" following randomization to 12 weeks or end of study.

Vital Signs - Pulse

Clinically significant changes in Temperature will be assessed for "normal" or "abnormal" following randomization to 12 weeks or end of study.

Vital Signs - Temperature

Changes in laboratory analytes will be classified as "normal" or "abnormal" (example: white blood cell counts)

Laboratory Analytes

Overall Study

Dr. K.N. Roy Chengappa - PI

Schizophrenia

Schizoaffective Disorder

Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera

Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.

Western Psychiatric Institute & Clinic

Withania Somnifera: an Immunomodulator and Anti-inflammatory Agent for Schizophrenia

Sensoril® (Ashwagandha), an Immunomodulator and Anti-inflammatory Agent for Schizophrenia: A Parallel Group, Randomized Double Blind, and Placebo Controlled Study

withanolide/zápal

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

Withania Somnifera: an Immunomodulator and Anti-inflammatory Agent for Schizophrenia

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