Health Condition 1: null- Stress and Insomnia
Conditions
Interventions
Intervention1: Ayumem Capsule: It Contains Centella asiatica, Convolvulus pluricaulis, Withania somnifera, Glycerrhiza glabra, Asparagus racemosus, Celastrus paniculatus.
Dosage and Treatment Duratio
Sponsors
Welex Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects who perceive themselves to be under stress and having a score of between 14 -24 on the Perceived Stress Scale (PSS). 2.Subjects not having any other psychiatric conditions than stress. 3.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form
Exclusion criteria
Exclusion criteria: 1. Subjects suffering from any chronic physical, hormonal or psychiatric illness. 2. Subjects using oral or systemic contraceptive medications. 3. Subjects with uncontrolled diabetes and hypertension. 4. Subjects with substance dependence. 5. Chronic alcoholics and Habitual Tobacco chewers. 6. Known cases of Severe/Chronic hepatic or renal disease. 7. Known subject of any active malignancy. 8. Subjects giving history of significant cardiovascular event 9. Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 10. Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes. 11. Subjects using any other investigational drug within 1 month prior to recruitment or Subjects currently participating in any other Clinical study. 12. Known hypersensitivity to any of the ingredients used in study drug. 13. Pregnant and Lactating females. 14. Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of Ayumen Capsules on stress using perceived stress scale (PSS) in comparison to placebo Timepoint: Day-3, Day 0, Day 30, Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of Ayumem Capsules on stress using perceived stress scale 2. Assessment of severity of Insomnia on Insomnia Severity Index. 3. Assessment of pre and post serum cortisol (morning). 4. Assessment of Quality of Life on GHQ28 Scale. 5. Assessment on vitals and adverse event. 6. Global assessment for overall change by investigator and Subject. 7. Assessment of tolerability of study drugs by investigator and subject. 8. Assessment of lab parameters Timepoint: Day-3, Day 0, Day 30, Day 60 | — |
Countries
India
Contacts
Public ContactVandana Bade
Target Institute of Medical Education and Research
Outcome results
None listed