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Homoeopathic treatment of chronic sleeplessness

Efficacy of individualized homoeopathic medicines in the management of chronic insomnia in adults: Double-blind, randomized, placebo-controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/064757
Enrollment
54
Registered
2024-03-26
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

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

Conditions

Health Condition 1: G470- Insomnia

Interventions

Intervention1: Individualized homoeopathic medicines in centesimal potency plus concomitant care: Intervention is planned as administering indicated homoeopathic medicines in centesimal potencies (CH)
dosage and repetition depending upon the individual requirement of the cases. Patients will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within

Sponsors

D. N. De Homoeopathic Medical College and Hospital
Lead Sponsor

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

MeasureTime frame
Pittsburg Sleep Quality Index (PSQI)Timepoint: At baseline, every month, 3months

Secondary

MeasureTime 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

Public ContactBidisha Ray

D. N. De Homoeopathic Medical College and Hospital

bidisharay66@gmail.com9163969154

Outcome results

None listed

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