Health Condition 1: F489- Nonpsychotic mental disorder, unspecified Health Condition 2: null- patients suffering from insomnia
Conditions
Interventions
Intervention1: Tagaradi Capsule: 2 capsules of 500 mg with luke warm milk once at bedtime for 8 weeks
Control Intervention1: Placebo (starch) capsule: 2 capsules of 500 mg with luke warm milk once at
Sponsors
IPGT RA GAU Jamnagar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of both sexes in between the age group 18-75 years. 2. Patients suffering from following type of disturbed sleep pattern. 1) Sleep onset insomnia (Difficulty to taking sleep at the beginning of the night) 2) Sleep maintenance insomnia (Difficulty to maintain the sleep) 3) Nocturnal awakening (Difficulty to returning to sleep after awakening in the middle of the night or wakening early in the morning) 4) Rebound insomnia (Patients who has developed dependence to sedatives) 5) Circadian rhythm disorders (Sleeping pattern changes) 6) Patients having insomnia more than 2 weeks, less than 6 months 3. Patients of insomnia with mild hypertension, mild depression and anxiety disorders without any complains of other major diseases.
Exclusion criteria
Exclusion criteria: •Patients less than 18 years and more than 75 years. •Patients suffering from fatal familial insomnia. •Insomnia with major psychiatric illness like, Schizophrenia, Depressive psychosis, Epilepsy, etc. •Patients having advanced chronic illness like Bronchial asthma, Diabetes mellitus, Malignancy, Liver cirrhosis, Chronic renal failure, etc. •Patients with alcohol or drug dependency will be excluded. •Patients having acute illness like Cardiovascular accidents, Myocardial infarction, Chronic obstructive pulmonary disease. •Pregnant woman and planning to be pregnant within six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| relief in signs and symptoms of Anidra (Insomnia)Timepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| relief in signs and symptoms of Anidra (Insomnia) and regular normal sleepTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr A R Dave
IPGT RA Jamnagar Gujarat
Outcome results
None listed