Health Condition 1: null- Chronically stressed patients
Conditions
Interventions
Intervention1: Standardized Withania somnifera extract: 1 capsule of 125 mg WSE + 1 Placebo capsule
Intervention2: Standardized Withania somnifera extract: 2 capsules of 125 mg WSE
Intervention3:
Sponsors
Natreon Inc Research And Development Centre
Eligibility
Inclusion criteria
Inclusion criteria: Subjects meeting all the following criteria will be included in the study 1. Subjects between the age group of 18 â?? 70 years of either sex. 2. Subjects who fit into either Grades 1, 2 and 3 on the Objective physical health scale (ref: Vaillant GE, Mukamal K. Successful Aging. Am J Psychiatry 2001; 158:839â??847) 3. Subjects who are stable on medications with no change in medication in the last 4 weeks and who have the results of the following investigations in the standard laboratory range (± 10%) : Hb, CBC, ESR, Urine 4. Subjects who have a mHAM-A of > 28 for physical symptoms and > 19 for cognitive/ mood/ behavioural symptoms. 5. Women should have a negative urine pregnancy test at screening and should be willing to use adequate methods of contraception (OC pills /double barrier methods) or should have no childbearing potential (surgically sterilized or postmenopausal for 1 year). 6. Subjects ready to abide by trial procedures and willing to give written informed consent.
Exclusion criteria
Exclusion criteria: Subjects presenting with any of the following criteria will be excluded from the study. 1. Subjects who are taking antidepressant, antipsychotic and anxiolytic medications. 2. Subjects with a history of intake of any herbal / ayurvedic/ homeopathic medicines for any indication. in the last one month. 3. Subjects with a presence of clinically significant laboratory abnormality at screening e.g. significant abnormality of Liver Function Test (more than 2.5 times upper limit of normal) & Renal Function Test (more than 1.5 times upper limit of normal). 4. Subjects with drug/alcohol addictions 5. Subjects who have received in the 3 months prior to screening any systemic glucocorticoid treatment. 6. Subjects with history of hospital admission (hospital stay > 24 hours) with medical/surgical complications in the last1 month. 7. Subjects with history of infectious diseases in the last 1 month 8. Subjects with any known hypersensitivity to the components of the test medicine. 9. Women who are pregnant or breastfeeding or fertile women who are not practicing adequate methods of contraception (OC pills /double barrier methods). 10. Subjects who have received any investigational drug within the previous 1 month. 11. Subjects who are simultaneously participating in any other clinical trial. 12. Subjects with any other condition which in the opinion of the investigator would make the him/her unsuitable for the study or compromise his/her safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy end-points are â?¢ Change in mHAM-A scores at day 60 from the baseline. Timepoint: 0 days 60 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Evaluate safety of standardized WSE. 2.To assess the percentage of subjects achieving a mHAM-A of 28 for physical symptoms and 19 for cognitive/ mood/ behavioural symptoms with standardized WSE as compared to placebo on day 60. 3.Evaluate the change in the mean score of each component of Clinical Global Impressions (CGI) scale as compared to placebo Timepoint: 0 days 30 days 60 days | — |
Countries
India
Contacts
Public ContactDr Dipankar Banerjee
Natreon Inc, Kolkata
Outcome results
None listed