Health Condition 1: G470- Insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patient suffering from Chronic insomnia [ICD 11 Code: 7A00] 2.Insomnia severity index score more than 7. 3.Age 18 to 65 years and of either sex. 4.Participants having prior experience or knowledge of the treatment. Example- primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet.
Exclusion criteria
Exclusion criteria: 1.presence of a significant current medical like cancer or neurological disorder such as dementia, Parkinson disease which compromises sleep. 2.presence of a major psychopathology like major depressive disorder, anxiety disorders. 3.Alcohol or drug abuse during the past year. 4.Evidence of another sleep disorder such as sleep apnea that is apnea-hypopnea index more than 15 or periodic limb movements during sleep that is myoclonic index with arousal more than 15. 5.A score of 7 or low on Insomnia Severity Index 6.Use of psychotropic or other medications known to alter sleep (e.g. bronchodilators) and (g)use of a sleep-promoting agent (e.g. benzodiazepines). 7.Uncontrolled or unstable systemic or psychiatric diseases and/or infections affecting quality of life. 8.Patients who are too sick for consultation. 9.Pregnant and puerperal women, and lactating mothers. 10.Substance abuse and/or dependence. 11.Self-reported immune-compromised state. 12.Undergoing Homoeopathic treatment for any chronic disease within last 6 months. 13.Uncontrolled hypertension, diabetes, nephritic syndrome, renal insufficiency, uncontrolled hypothyroidism, severe or active liver diseases or any other uncontrolled systemic diseases affecting quality of life or organ failure. 14.Vulnerable population- unconscious, non-ambulatory, too sick for consultation, differently abled, terminally and critically ill patient, mentally unstable patients. 15.Patient not providing with written informed consent voluntarily.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburg Sleep Quality Index (PSQI)Timepoint: At baseline, every month, 3months | — |
Secondary
| Measure | Time frame |
|---|---|
| Daily Sleep Diary with Master Sleep Diary Calculator (MSD)Timepoint: At baseline, every month, up to 3 months;Insomnia Severity Index (ISI)Timepoint: At baseline, every month, up to 3 months | — |
Countries
India
Contacts
D. N. De Homoeopathic Medical College and Hospital