A Comparative Study of Massage Therapy, Herbal Preparation, and Their Combination in Patients with Primary Insomnia

Comparative Study of Dalk -I- Layyin with Rvghan -e- Kahu Harira Maghz -i- Badam Wala and their Combination in Primary Insomnia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/101639

Enrollment

Registered

2026-01-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: F139- Sedative, hypnotic or anxiolytic-related use, unspecified

Interventions

Intervention1: Dalk i Layyin with Ravghan i Kahu: Dalk i Layyin is a gentle massage therapy described in Unani medicine and used to relax the body and calm the nervous system. When performed with Ravg

Eligibility

Inclusion criteria

Inclusion criteria: Patients of both gender Age group 18-60 years Diagnosed with Primary Insomnia. Patients were selected on the basis of DSM-V-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) diagnostic criteria for primary insomnia

Exclusion criteria

Exclusion criteria: Presence of significant psychiatric disorders, including major depression, anxiety disorders, psychosis, or epilepsy Patients with serious somatic illnesses such as severe respiratory, cardiovascular, endocrine disorders, or hepatic/renal insufficiency. History of alcohol or substance abuse. Patients with disease requiring long term treatment Pregnant or lactating women. Individuals engaged in night-shift work or those with irregular sleep patterns who are unable or unwilling to modify their work schedule. History of suicidal ideation or behaviour Use of psychiatric medications, hypnotics, or antihistamines within four weeks prior to baseline. However, individuals who used prescription or over-the-counter hypnotics no more than twice per week may be included after appropriate washout Use of any alternative or complementary therapies during the study period. Presence of primary sleep disorders such as restless legs syndrome, circadian rhythm sleep disorders, or parasomnias.

Design outcomes

Primary

Measure	Time frame
Change in sleep quality and severity of insomnia assessed using standardized scales (Pittsburgh Sleep Quality Index [PSQI] and Insomnia Severity Index [ISI])Timepoint: Primary outcome assessment will be done at the following time points 1 Baseline before initiation of treatment to record PSQI and ISI scores 2 At the end of the treatment period (4 weeks) to assess change in PSQI and ISI scores from baseline	—

Measure

Time frame

Change in sleep quality and severity of insomnia assessed using standardized scales (Pittsburgh Sleep Quality Index [PSQI] and Insomnia Severity Index [ISI])Timepoint: Primary outcome assessment will be done at the following time points 1 Baseline before initiation of treatment to record PSQI and ISI scores 2 At the end of the treatment period (4 weeks) to assess change in PSQI and ISI scores from baseline

—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDr Huma

Regional Research Institute of Unani Medicine Srinagar

akram.laeeque@ccrum.res.in7500877065

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026