Health Condition 1: F489- Nonpsychotic mental disorder, unspecified
Conditions
Interventions
Intervention1: HFSM-02: HFSM-02 at the dose of 1 BD for 60 days
Control Intervention1: Placebo: Placebo at the dose of 1 BD for 60 days
Sponsors
Siddhayu Ayurvedic Research Fdn Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects of age between 18 and 60 years Free of psychiatric conditions other than stress Have a score less than 15 on the World Health Organizationâ??five (WHO-5) well-being index and a score of at least 14 on the Perceived Stress Scale (PSS) CHD patients showing one or more of the following conditions like hypertension, dyslipidemia, atherosclerotic, ischemic changes, with certain psychological stress-related complaints mainly irritation, anxiety, etc. on stable medical prescriptions. Prediagnosed diabetes type 2 patients with HbA1c including but NMT 7.5 with certain psychological stress-related complaints mainly irritation, anxiety, etc. and on stable medical prescription
Exclusion criteria
Exclusion criteria: Subjects suffering from any chronic physical, neurological or psychiatric illness Subjects currently undergoing active MI episode Subjects with uncontrolled diabetes Subjects with compromised liver or renal function test as per sole discretion of investigator that can prove the subject unfit for the trial Subjects currently taking any herbal preparations or formulations containing Ashwagandha, ginseng, ginkgo biloba, Brahmi or related herbs, Subjects pregnant or lactating Subjects with substance dependence Subjects in investigators opinion not fit for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Profile of mood states (POMS-2) Depression and Anxiety Stress Scale 21 (DASS-21) Graded symptom scale for irritation, poor concentration and weak memory General Health Questionnaire â?? 28 (GHQ-28) Stress related disturbed sleep cycle index Serum cortisol levelsTimepoint: Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60) | — |
Secondary
| Measure | Time frame |
|---|---|
| Daytime fatigue using Fatigue Severity Scale (FSS) Daytime mood, ability to function at work, concentration and memory at work place a graded scale. Safety parameters like CBC, LFT, KFT, lipid profile, urine routine, fasting blood sugar, PP blood sugar, ECG. Drug compliance Timepoint: Baseline Visit (Day 0), Visit 1 (Day 30), Visit 2 (Day 60) | — |
Countries
India
Contacts
Public ContactMr Sharad Dhurde
Siddhayu Ayurvedic Research Fdn Pvt Ltd
Outcome results
None listed