Health Condition 1: G470- Insomnia Health Condition 2: F510- Insomnia not due to a substance orknown physiological condition
Conditions
Interventions
Intervention1: IKSEER E SHIFA: 01 tablet of 520 mg orally twice a day with 250 ml of milk after
meals.IKSEER E SHIFA 520mg Tablet (Containing Asrol,Nishahta gandum,Milk of Sugar,Chalk powder)
Control
Sponsors
STATE TAKMEEL UT TIB COLLEGE AND HOSPITAL
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient meets DSM-5 criteria for Primary insomina:more than equal to 3 nights/week for more than equal to 3 months. 2.Patients with ISI more than equal to 15 (moderate severe insomnia). 3.Patient who will give consent, willing to avoid new sleep meds/psychotherapy during trial, maintain stable caffeine/alcohol habits and are able to do follow up.
Exclusion criteria
Exclusion criteria: 1. Patients with history of Major psychiatric co-morbidity (MDD with Suicidality, psychosis bipolar). 2. Patients with history of otheir primary sleep disorders: restless legs/ PLMD (Periodic Limb Movement Disorder), circadian rhythm disorders (due to jet lag or night or rotating shifts), parasomnias needing treatment. 3. Patients with history of current use of hypnotics, benzodiazepines, antipsychotics, sedating antihistamines within 04 weeks. 4. Patients with severe systemic illnesses. 5. Pregnant, planning pregnancy, or breastfeeding women of childbearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in ISI,ESS and RIS.Timepoint: 4 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| SF-12Timepoint: Baseline,4th week | — |
Countries
India
Contacts
Public ContactProf Mohammad Shahid
State Takmeel Ut Tib College and Hospital Lucknow
Outcome results
None listed