A clinical study to evaluate the Effect of Ayurvedic Therapies with Ksheerabala Taila as an add on to Cognitive Behavioural Therapy for Insomnia in Perimenopausal Women

Randomized Controlled Trial evaluating Ayurvedic therapies- Siro pichu and Padabhyanga with Ksirabala Taila as an Add on to Cognitive Behavioural Therapy-Insomnia (CBT-I) for the management of Insomnia in Perimenopausal Women - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/11/098172

Enrollment

Registered

2025-11-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Women aged 45 to 55 years Insomnia Severity Index(ISI ) score in between 8-21; identified by symptoms of difficulty initiating or maintaining sleep, or early morning awakening, occurring at least three nights per week, persisting for a minimum duration of three months, and associated with clinically significant distress or impairment in daytime functioning. Able to understand and comply with CBT instructions. Able to provide written informed consent.

Exclusion criteria

Exclusion criteria: Known cases of Hypertension, Thyroid disorders, and Diabetes Mellitus. Those who require HRT during their menopausal period. PHQ-9 Depression scale Score greater than 5. Under medication for any psychological or psychiatric disorders & substance use in the past 30 days. Any active medical or neurological conditions causing sleep disruption. No access to mobile phones and internet. Engagement in rotating shift work or any known lifestyle factors that disrupt normal sleep timing. Use of sleep inducing medications, anti depressants, anti psychotics or sedatives in the past 30 days BMI greater than 35

Design outcomes

Primary

Measure	Time frame
Change in Insomnia Severity Index total score and Pittsburgh Sleep Quality Index score from baseline to end of interventionTimepoint: Primary Outcome will be assessed at baseline and at four weeks of intervention	—

Secondary

Measure	Time frame
Early therapeutic response assessed using Insomnia Severity Index total score at Week 2; longitudinal change in Insomnia Severity Index total score during follow up at Weeks 6 8 10 and 12; change in Pittsburgh Sleep Quality Index score during follow up at Weeks 4 8 and 12; occurrence and characterization of clinically relevant events using validated adverse event and adverse drug reaction monitoring checklist; behavioural dependency risk assessed using Severity of Dependency Scale total score; treatment adherence and fidelity assessed using Daily Sleep and Treatment Engagement DiaryTimepoint: Week 2 Weeks 4 6 8 10 and 12 Baseline to Week 12 and daily during intervention	—

Measure

Time frame

Early therapeutic response assessed using Insomnia Severity Index total score at Week 2; longitudinal change in Insomnia Severity Index total score during follow up at Weeks 6 8 10 and 12; change in Pittsburgh Sleep Quality Index score during follow up at Weeks 4 8 and 12; occurrence and characterization of clinically relevant events using validated adverse event and adverse drug reaction monitoring checklist; behavioural dependency risk assessed using Severity of Dependency Scale total score; treatment adherence and fidelity assessed using Daily Sleep and Treatment Engagement DiaryTimepoint: Week 2 Weeks 4 6 8 10 and 12 Baseline to Week 12 and daily during intervention

—

Countries

India

Contacts

Public ContactDevipriya Soman

Amrita School of Ayurveda

dr.parvathy@ay.amrita.edu9497882774

Outcome results