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A comparative study to assess the efficacy of Ayurvedic formulation and Cognitive Behavioural Therapy in managing Insomnia

To compare the efficacy of combination of Takra Bilva Prayoga and Cognitive Behavioural Therapy with Cognitive Behavioural Therapy alone in improving the quality of sleep in Primary Insomnia- a randomized clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/055113
Enrollment
46
Registered
2023-07-12
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

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

Sponsors

Vaidyaratnam Ayurveda College
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: DSM â?? V criteria Dissatisfaction with sleep quantity or quality, with one or more of the following symptoms: • Difficulty initiating sleep • Difficulty maintaining sleep • Early morning awakening with inability to return to sleep • Sleep disturbances leading to impaired day time functioning evidenced by atleast one of the following : fatigue or low energy Daytime sleepiness Impaired attention, concentration or memory Mood disturbance Behavioural difficulties Impaired occupational or academic function Impaired interpersonal or social function Negative effect on caregiver or family functioning The sleep difficulty occurs at least three nights per week, is present for at least three months, and occurs despite adequate opportunity for sleep.

Exclusion criteria

Exclusion criteria: Insomnia associated with other sleep disorders (eg- narcolepsy, breathing related sleep disorder, circadian rhythm sleep wake disorder, parasomnia). • Insomnia caused by mental disorders and medical conditions. • Participants taking allopathic medications for insomnia. • Participants with chronic systemic diseases. • Participants with uncontrolled hypertension. • Pregnant and lactating women. • Participants with alcohol dependence and substance abuse • Participants who have been part of any other study in the past 6 months.

Design outcomes

Primary

MeasureTime frame
Insomnia Severity IndexTimepoint: Insomnia Severity Index at every 7 day & 1 week after follow up

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr P V Giri

Vaidyaratnam Ayurveda College

doctorviswagiri@gmail.com9447527366

Outcome results

None listed

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