None listed
Conditions
Sponsors
Shri Kartikeya Pharma
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adult male or female patients aged between 18 â?? 60 years of age 2.Patients with routine work stress 3.Patients stress disorders characterized with difficulty in concentration, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, phobia, sweating, mental confusion etc. 4.Patients with Perceived Stress Scale (PSS) score more than or equal to 20 (high stress level) 5.Body mass index between 25 and 39.9 kg/m2
Exclusion criteria
Exclusion criteria: 1.Participants who have a diagnosable eating disorder will also be excluded since intentional restriction of eating and binge eating/overeating could increase the variability of the data 2.Currently (in the past three months) attending a weight loss program 3.Underlying genetic or endocrine cause for weight gain 4.Medications known to affect weight (corticosteroids, antidepressants, anti-psychotics, mood stabilizers, and anti-epileptic medications) 5.History of Alcohol or smoking abuse 6.Have clinically significant acute unstable hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study 7.Patients with depressive episode, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania 8.Patients with post traumatic disorder 9.Have an established practice of meditation for three or more months 10.Pregnant and lactating women 11.Subjects with known hypersensitivity to Ashwagandha 12.Participation in other clinical trials during previous 3 months 13.Any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement from baseline in Perceived Stress Scale score (PSS) after 8 weeks.Timepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Body mass index (BMI) and absolute and percentage weight loss will be compared.Timepoint: 8 weeks;Change from baseline in vital signsTimepoint: 8 weeks;Change in WeightTimepoint: baseline, week 4 and week 8;Improvement from baseline in the score for Oxford Happiness Scale after therapyTimepoint: baseline, week 4 and week 8;Improvement from baseline in urine cortisol levelTimepoint: baseline, week 4 and week 8 | — |
Countries
India
Contacts
Public ContactDr Dnyanraj Choudhary
Atur Sangtani
Outcome results
None listed