Health Condition 1: F411- Generalized anxiety disorder
Conditions
Interventions
Intervention1: Ocitum™ (Tulsi Leaf Extract): Ocitum™ (Tulsi Leaf Extract) capsule
2 capsules a day (Each containing 150mg) Route: Oral
Regimen: 1 capsule twice a day with water
Duration: 8 weeks – 56
Sponsors
K Patel Phytoextractions Pvt Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Able to provide written informed consent. 2. Able and willing to comply with the protocol, including availability for all scheduled study visits. 3. Male and female aged between 18 and 65 years (both inclusive), as of the screening date. 4. Individuals experiencing stress for longer than a month, and currently experiencing insomnia/sleep problems (either difficulty falling asleep, staying asleep, or unrefreshing sleep). 5. Participants are required to score minimum 10-20 on Depression, 8-14 on anxiety & 15-25 on stress on DASS-21. 6. No history of addiction to any recreational drug or drug dependence. 7. Subjects who are non-alcoholic and non-smokers. 8. Subjects with no ongoing pre-existing medical conditions. 9. Subjects not currently taking medicines or supplements for stress, anxiety or sleep disturbance.
Exclusion criteria
Exclusion criteria: 1. Participants will not be eligible if they have a serious psychiatric disorder or certain medical conditions, such as diabetes, high or low blood pressure, heart disease, or gastrointestinal issues. 2. Participants requiring regular use of medications for gallbladder disease, autoimmune disease, endocrine disease, or acute or chronic pain conditions. 3. Females who are pregnant or planning pregnancy, lactating, or taking any oral contraceptives. 4. Individuals consuming more than 4 cups of coffee (or equivalent caffeine levels from other sources) or taking herbal or vitamin supplements that are anticipated to significantly influence study outcomes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective: To assess the effect of Ocitum™ on severity of depression, anxiety & stress using Depression, Anxiety, Stress Scale (DASS-21) throughout the study period. To assess the effect of Ocitum™ on severity of sleep using Stanford Sleepiness Scale (SSS) throughout the study period. To assess the effect of Ocitum™ on various parameters of sleep: Sleep Latency, Sleep Efficiency & Sleep Duration throughout the study period.Timepoint: Primary Objective: To assess the effect of Ocitum™ on severity of depression, anxiety & stress using Depression, Anxiety, Stress Scale (DASS-21) throughout the study period. To assess the effect of Ocitum™ on severity of sleep using Stanford Sleepiness Scale (SSS) throughout the study period. To assess the effect of Ocitum™ on various parameters of sleep: Sleep Latency, Sleep Efficiency & Sleep Duration throughout the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective(s): • To evaluate the effect of Ocitum™ on Serum Cortisol levels throughout the study period. • To assess the effect of Ocitum™ on CBC, SGPT & S. Creatinine. • To assess improvement in QoL using WHOQOL-BREF throughout the study period. • To assess the safety of Ocitum™ throughout the study period.Timepoint: Secondary Efficacy Endpoint(s) [Time frame: Baseline to Week 8 (Day 57)] • Change in S. Cortisol levels • Change in CBC (Complete Blood Count) parameters • Change in S. Creatinine levels • Change in SGPT levels • Improvement in WHOQOL-BREF score Note: All the changes are considered from baseline to end of treatment. Safety Endpoints [Time frame: Baseline to Week 10 (Day 71)] • Number and types of adverse (AEs) and serious adverse events (SAEs) | — |
Countries
India
Contacts
Public ContactMr Nimish Dudhatra
Concept Clinical Services
Outcome results
None listed