A comparative study to assess the efficacy of Ayurvedic formulation and Cognitive Behavioural Therapy in managing Insomnia
- Conditions
- Health Condition 1: F510- Insomnia not due to a substance orknown physiological condition
- Registration Number
- CTRI/2023/07/055113
- Lead Sponsor
- Vaidyaratnam Ayurveda College
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Insomnia Severity IndexTimepoint: Insomnia Severity Index at every 7 day & 1 week after follow up
- Secondary Outcome Measures
Name Time Method ILTimepoint: NI