Health Condition 1: G470- Insomnia
Conditions
Interventions
Intervention1: Tulsi Odaat® Capsule: Contains Tulsi 2.5% Extract (Ocimum sanctum) and Ursolic acid
Dosage and Treatment Duration: 1 Capsule twice daily orally after meals with water for a period o
Sponsors
LODAAT PHARMA
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects diagnosed with Insomnia Disorder based on DSM-5 Diagnostic Criteria for Insomnia Disorder 2. Insomnia Severity Index more than 7 and less than 21 3. Subjects willing to sign inform consent form 4. A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period 5. Willing to stop alcohol, caffeine, and nicotine consumption while in the study
Exclusion criteria
Exclusion criteria: 1. History or diagnosis of any other disease resulting in another sleep disorder 2. History of bipolar disorder, psychotic disorder, or posttraumatic stress disorder or current psychiatric disorder that requires medication 3. On-going depression and generalized anxiety disorder 4. History of substance abuse or dependence 5. History or current evidence of a clinically significant cardiovascular disorder or clinically significant electrocardiogram (ECG) at screening visit 6. Taking prohibited medications [opium, cannabis (marijuana) and methamphetamines] 7. Subjects with habit of smoking 8. Subjects with known history of hepatitis B and/ or C 9. History of malignancy 10. Known hypersensitivity to any of the ingredients of â??Tulsi Odaat® Capsuleâ?? 11. 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 |
|---|---|
| 1.Change in patient-reported total sleep time (as per patient diary) 2. Change in sleep efficiency Timepoint: Day-3, Day 0, Day 14, Day 28, Day 35 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in patient-reported time to sleep onset, number of awakenings and WASO 2. Requirement of sedatives as rescue medication 3. Change in severity of Insomnia 4. Changes in daytime fatigue, mood, ability to function at work, concentration and memory 5. Assessment of Quality of sleep on PSQI and rebound of insomnia 6. Global assessment for overall change by investigator and by patient 7. Assessment of tolerability of study drug, adverse events, vitals and safety lab parameters Timepoint: Day-3, Day 0, Day 14, Day 28, Day 35 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed