None listed
Conditions
Interventions
Intervention1: Sleep Rhythm Capsules (SRC): 2 Capsules at bedtime daily with water for 30 days
Control Intervention1: Placebo Capsule: 2 Capsules at bedtime daily with water for 30 days
Sponsors
Transformative Learning Solutions Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants aged greater than or equal to 21 and less than 65 years at the time of obtaining written informed consent 2. Participants with score between 7-21 on ISI (Insomnia severity index) 3. Participants willing to sign inform consent form and ready to follow the study protocol requirements 4. A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period
Exclusion criteria
Exclusion criteria: 1. Participants with history or diagnosis of secondary sleep disorder (any other underlying medical or surgical condition diagnosed on the basis of history and clinical examination by the investigator) 2. Participants with history of any neurological disorder causing interference in sleep 3. Participants with history of bipolar disorder, psychotic disorder, or posttraumatic stress disorder, or current psychiatric disorder that requires medication 4. Participants with On-going depression & generalized anxiety disorder 5. Participants with history of drug or alcohol addiction or abuse within the past 12 months 6. Participants with habit of smoking Cigarette (Average of more than 5 cigarettes per day over the last 5 years) 7. Participants with known history of hepatitis B and or C 8. Participants with history of malignancy less than or equal to 5 years prior to study participation 9. Participants with shift work disorders and other psychiatric disorders which need medication 10. Participants with known hypersensitivity to any of the ingredients of study products 11. Participants with other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his/her participation in, and completion of the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in sleep parameters [Onset of sleep latency (SOL), Sleep Efficiency (SE), Total Bed time (TBT), Total Sleep Time (TST), Wake after Sleep Onset (WASO), Light Sleep, Deep Sleep, REM Sleep,] using Actigraphy 2. Change in sleep efficiency (Total sleep time/ Time in bed X 100) time of sleep onset, number of awakenings and wake time after sleep onset, (as per participant diary). Timepoint: Baseline visit, Day 7, Day 15, and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in severity of sleep disturbance using Insomnia Severity Index 2 Change in daytime fatigue using Fatigue Severity Scale (FSS) 3.Change in daytime mood, ability to function at work, concentration 4. Change in Quality of sleep on Pittsburgh Sleep Quality Index (PSQI) 5. Change in stress assessed on perceived stress scale (PSS) 6. Global assessment for overall change (CGI I) 7. Assessment of non habit forming property of the study products 8. Change in feeling of relaxation, calmness, deep sleep on VAS 9. Assessment of Restless thoughts, racing thoughts before sleep 10. Change in quality of life by assessing WHO QOL 11. Change in day time drowsiness, grogginess or brain fog 12. Assessment of safety and tolerability of study products Timepoint: Baseline visit, Day 7, Day 15, and Day 30 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Transformative Learning Solutions Pvt Ltd
Outcome results
None listed