None listed
Conditions
Interventions
Intervention1: Shagandha: One capsule once a day before bedtime for 60 days.
Control Intervention1: Placebo (Microcrystalline cellulose): One capsule once a day before bedtime for 60 days.
Sponsors
Sami Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and female healthy adults 21 to 54 years old. 2 Body Mass Index (BMI) in the range of 18 to 32 kg/m2. 3 Subjects free of any psychological or psychiatric conditions except stress & anxiety. 4 Adults with perceived stress scale score less than 25 and more than 14. 5 Adults complaining with anxiety,fatigue,loss of appetite,Insomnia and loss of concentration. 6 Subject must be willing and able to adhere to the assessments,visit schedules, prohibitions and restrictions,as described in this protocol. 7 Willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1 Pregnant and lactating female or female having the intention to be pregnant within next three months. 2 Education level below 8th grade of schooling. 3 Unable to read or understand English or having no working knowledge of English. 4 History of alcohol abuse, excessive smoking with more than 5 cigarettes a day. 5 Established/ diagnosed neurological or psychiatric disorders. 6 With chronic gastrointestinal diseases, severe immune deficiency. 7 Lipid profile, haematological parameters, Glycaemic parameters above normal limits. 8 History of intake of ANY Ayurvedic/herbal/homeopathic/ dietary supplements (including Vitamin E) or any alternative therapies in the last one month. 9 History of bone marrow disorders. 10 Acute medical/surgical complications which require hospitalization. 11 Subjects with history of clinically significant thyroid disorder (hypo or hyper), cardiovascular, haematological,hepatic (SGOT or SGPT levels >2 Upper Limit of Normal),renal (serum creatinine>=1.3 mg/dl), respiratory,or genitourinary abnormalities or diseases. 12 A history of significant multiple and/or severe allergies or anaphylactic reactions. 13 Subjects with known history of hypersensitivity to the investigational product. 14. Subject has participated in any clinical trial within last 3 months. 15. Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Change in CANTAB score 2 Change in PSS scale 3 Change in WHOQOL-BREFTimepoint: 1 CANTAB score(Day0 & Day60) 2 PSS scale(Screening,Day30 & Day60) 3 WHOQOL-BREF(Day0 & Day60) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Change in Generalized Anxiety Disorder - 7 item scale. 2 Change in Salivary cortisol. 3 Change in Urine Serotonin and Dopamine. 4 Change in Anti oxidant stress biomarkers - Nitric oxide,Glutathione and Malondialdehyde. 5 Change in Laboratory parameters. 6 Safety of IP determined upon occurrence of Adverse events.Timepoint: 1 Generalized Anxiety Disorder - 7 item scale (Screening,Day30 & Day60). 2 Salivary cortisol(Day0 & Day60). 3 Urine Serotonin and Dopamine (Day0 & Day60). 4 Anti oxidant stress biomarkers(Day0 & Day60). 5 Laboratory parameters(Screening, Day30 & Day60). 6 Adverse events(Day30,Day60 & telephonic follow up after 15 days). | — |
Countries
India
Contacts
Public ContactDr Kalpesh Shah
ClinWorld Private Limited
Outcome results
None listed