A study to evaluate the Efficacy of E-IN-05 in subjects of Primary Insomnia

An Exploratory, Open Label study to evaluate the Efficacy of E-IN-05 in subjects of Primary Insomnia

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/11/002130

Enrollment

Registered

2011-11-16

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Primary Insomnia

Interventions

Intervention1: E-IN-05: Each Capsule contains: Hypericum perforatum - 100 mg Nardostachys grandiflora - 100 mg Celastrus paniculatus - 75 mg Magnesium - 200 mg Zinc - 40 mg Dosage: 2 Caps at night wi

Eligibility

Inclusion criteria

Inclusion criteria: - 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

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
1) Decrease in sleep latency 2) Modified Pittsburgh Sleep Quality Index Timepoint: 1) Day 0, Day 21 and Day 42 2) Day 0, Day 21 and Day 42	—

Countries

India

Contacts

Public ContactSeema Damakale

Enovate Biolife Pvt. Ltd.

shalini@enovatebiolife.com022-42172327

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026