Health Condition 1: G470- Insomnia Health Condition 2: Z733- Stress, not elsewhere classified
Conditions
Interventions
Intervention1: AshwaDaat® Capsule: Contains Ashvagandha (Withania somnifera) Root Extract (Standardized to Withenoloids NLT 5%) and Marich (Piper nigrum) Fruit Extract
Dosage and Treatment Duration
Sponsors
LODAAT PHARMA
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects who perceive themselves to be under stress and having a score between 14 -24 on the Perceived Stress Scale (PSS) 2.Subjects not having any psychiatric conditions other 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 on treatment for stress and insomnia 3.Subjects using oral or systemic contraceptive medications 4.Subjects with uncontrolled diabetes and hypertension 5.Subjects with substance dependence 6. Chronic alcoholics and Habitual Tobacco chewers. 7.Known cases of Severe/Chronic hepatic or renal disease. 8.Known case of any active malignancy. 9.Subjects giving history of significant cardiovascular event 10.Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 11.Known case of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes. 12.Subjects using any other investigational drug within 1 month prior to recruitment or Subjects currently participating in any other Clinical study 13.Known hypersensitivity to any of the ingredients used in study drug 14.Pregnant and Lactating females. 15.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 |
|---|---|
| Changes in stress on perceived stress scale (PSS)Timepoint: Day -3, Day 0, Day 15, Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in severity of Insomnia on Insomnia Severity Index 2. Change in pre and post serum cortisol (morning) level 3. Change in Quality of Life on GHQ28 Scale 4. Changes in vitals. 5. Assessment of occurrence adverse event 6. Global assessment for overall change by investigator and subject on CGI Scale 7. Assessment of tolerability of study drug by investigator and subject. 8. Assessment of safety by assessing safety lab parameters Timepoint: Day -3, Day 0, Day 15, Day 30 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed