Health Condition 1: - Health Condition 2: -
Conditions
Interventions
Intervention1: Shagandha�®: One capsule, once a day after dinner for 90 days
Control Intervention1: Placebo: One capsule, once a day after dinner for 90 days
Sponsors
SamiSabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female in the age of 18 to 60 years. 2. Hamilton Depression Rating Scale (HDRS) from 8 ââ?¬â?? 18. 3. Hamilton Anxiety Rating Scale (HARS) from 6-24. 4. Willingness to provide informed consent and comply with the trial protocol.
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, Uncorrected visual impairment, food allergies/insensitivities; any hormonal status likely to induce an unstable/fluctuating emotional state (e.g., menopausal transition); presence of life event likely to induce unstable/fluctuating emotional state (e.g., change of professional function/ situation, death of a family member, divorce, surgery); worked night shifts. 3. Engaged in high levels of physical activity; consumed >500 mg caffeine per day; current smokers and alcohol abusers. 4. Using medication or psychotherapy for depression. 5. Have major psychiatric, medical, or neurocognitive disorders that make participation infeasible or interfere with the adherence to the lifestyle intervention 6. With chronic gastrointestinal diseases, severe immune deficiency. 7. Not on stable doses of medications for blood pressure for at least one month prior to starting study medication or having uncontrolled hypertension > 160/100 mmHg. 8. Not on stable doses of medications for diabetes for at least one month prior to starting study medication or having uncontrolled HbA1c > 7.5%. 9. Having a history of stroke. 10. History of intake of ANY Ayurvedic/herbal/homeopathic/ dietary supplements (including Vitamin E) or any alternative therapies in the last one month. 11. History of acute medical/surgical complications which require hospitalization. 12. Participants with history of clinically significant thyroid disorder (hypo or hyper), cardiovascular (congenital heart disease, cardiomyopathy, heart failure, heart valvular disease) haematological, hepatic (SGOT or SGPT levels > 2 Upper Limit of Normal), renal (serum creatinine � 1.3 mg/dl), respiratory, or genitourinary abnormalities or diseases. 13. A history of significant multiple and/or severe allergies or anaphylactic reactions. 14. Participants with known history of hypersensitivity to the investigational product. 15. Participants who have participated in other clinical trial within last 3 months. 16. Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Mean change in the Hamilton Depression Rating Scale (HDRS) 2) Hamilton Anxiety Rating Scale (HARS)Timepoint: 1. Screening, Day 30, Day 60, and Day 90. 2. Screening, Day 30, Day 60, and Day 90. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change in Groningen Sleep Quality Scale 2. 2. Mean change in the serum serotonin 3. 3. Mean change in the WHO- quality of life Questionnaire 4. 4. Safety as determined by the changes in complete blood count (CBC), blood biochemistry test profile and occurrence of adverse events.Timepoint: 1. Day 0, Day 30, Day60 and Day 90 2. Day 0 and Day 90. 3. Day 0, Day 30, Day 60 & Day 90. 4. Screening, Day 30, Day 60 & Day 90. | — |
Countries
India
Contacts
Public ContactDr Kalpesh Shah
Sami-Sabinsa Group limited
Outcome results
None listed