A study to evaluate the Efficacy of E-IN-05 in subjects of Primary Insomnia
- Conditions
- Health Condition 1: null- Primary Insomnia
- Registration Number
- CTRI/2011/11/002130
- Lead Sponsor
- Enovate Biolife Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 20
Case of primary Insomnia as diagnosed by the investigator
- Sleep disorder indicated by one or more of the following:
- History of sleep duration of less than 4.5 hrs/ night
- History of sleep latency of >= 60 min
- History of tiredness post awakening
- History of presence of above symptoms for >= 6 months.
- Able and willing to follow all study related instructions and to make all required visits
- Subjects not willing to discontinue insomnia medication
- Secondary forms of insomnia
- Concurrent history/ treatment of acute psychiatric illness (such as schizophrenia, acute panic attack, major depressive disorder etc.).
- Subjects with history of a substance use disorder
- History of uncontrolled diabetes, hypertension and other metabolic disorder.
- Clinical history of allergy/ hypersensitivity to one or more products of herbal origin.
- Pregnant / lactating women and women who are planning to get pregnant
- Recent (within last 3 months) participation in a clinical trial
- Recent (within last 15 days) use of any, herbal or homeopathic product for the insomnia.
- A medical condition, which in the Investigatorâ??s opinion may pose a threat to patient compliance e.g. case of seizures.
- Subjects otherwise judged by the investigator or sub -investigator to be inappropriate for inclusion in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢Increase in sleep duration by 1-2 hrs/ day as assessed by patientâ??s sleep dairyTimepoint: â?¢Increase in sleep duration by 1-2 hrs/ day as assessed by patientâ??s sleep dairy
- Secondary Outcome Measures
Name Time Method 1) Decrease in sleep latency <br/ ><br>2) Modified Pittsburgh Sleep Quality Index <br/ ><br>Timepoint: 1) Day 0, Day 21 and Day 42 <br/ ><br>2) Day 0, Day 21 and Day 42