Skip to content

Homeopathic medicines for sleep disturbance

An open-label, randomized, placebo-controlled trial to evaluate the efficacy of Passiflora incarnata and individualized homeopathic medicines in insomnia

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/11/021931
Enrollment
60
Registered
2019-11-08
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: G470- Insomnia

Interventions

Intervention1: Passiflora incarnata in centesimal or 50 millesimal potencies, as decided appropriate to the case or condition: Intervention is planned as administering Passiflora incarnata in centesim
dosage and repetition depending upon the individual requirement of the cases. In 50 millesimal scale, a single cane sugar globule of poppy seed size (no. 10) medicated with Passiflora incarnata in 50
16 doses to be marked on the vial
dosage and repetition depending upon the individual requirement of the cases. The medicines will be procured from a Good Manufacturing Practice (GMP)-certified firm. The patients will be advised to ma

Sponsors

National Institute of Homoeopathy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients suffering from insomnia for more than 3 months 2. Both sexes 3. Age 18-65 years 4. Literate patients with ability to read Bengali or English 5. Patients willing to participate in the study and giving written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients who are too unwell to take part 2. Inability to read patient information sheets and/or denied consent to take part 3. Diagnosed cases of unstable psychiatric complaints or other systemic diseases affecting quality of life 4. Currently receiving standard therapy for insomnia and/or homeopathic treatment for any chronic condition(s) 5. Pregnant and lactating women 6. Self-reported immune compromised conditions 7. Substance abuse and/or dependence

Design outcomes

Primary

MeasureTime frame
Sleep efficiency score derived from sleep diaryTimepoint: Baseline, every month, up to 3 months

Secondary

MeasureTime frame
Daily sleep diary - five itemsTimepoint: Baseline, every month, up to 3 months;Insomnia Severity Index (ISI)Timepoint: Baseline, every month, up to 3 months

Countries

India

Contacts

Public ContactPratima Pal

National Institute of Homoeopathy

dr.pratimapal@gmail.com7679507608

Outcome results

None listed

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