To study the effect of Ayurvedic treatments in Insomnia

Effect of Integrated Ayurveda Treatment Protocol in Primary insomnia- A Randomised Comparative Clinical Trial - Nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/054890

Enrollment

140

Registered

2023-07-06

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: G470- Insomnia

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Individuals between the age group of 20 to 60 years having insomnia of minimum three month duration 2. Patients of Either sex. 3. Insomnia Severity Index >7 4. DASS-21 depression score <13, Anxiety score <9 and stress score <18

Exclusion criteria

Exclusion criteria: 1. Patients with known cases of psychiatric illness like schizophrenia, Major depressive disorder, Psychosis, Epilepsy, moderate to severe anxiety disorders. 2. Patients with Alcohol dependency or Drug dependency. 3. Patient with known cases of other sleep disorders like Narcolepsy, Breathing-related sleep disorder, Circadian rhythm sleep disorder, or Parasomnia 4. Patients with other known cases of systemic illness like Thyroid, Asthma, Malignancies, Liver disorders, Uncontrolled Hypertension, uncontrolled Diabetes mellitus & Chronic renal failure. 5. Use of Hypnotics by prescription, Psychotherapy within the past 4 weeks. 6. Pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
Changes in Insomnia severity indexTimepoint: at baseline, 15th & 30th day	—

Secondary

Measure	Time frame
Changes in Pittsburgh sleep quality index, from baseline & at 15th & 30th days. b. Changes in Epworth sleepiness scale from baseline and at 15th & 30th days. c. Changes in Manasabhava scale from baseline and at 15th & 30th days from baseline and at 15th & 30th days. d. Changes in Depression Anxiety and Stress Scale (DASS). Changes in Quality of life (SF36) from baseline and at 15th & 30th daysTimepoint: 0th day, 15th day, 30thday	—

Measure

Time frame

Changes in Pittsburgh sleep quality index, from baseline & at 15th & 30th days. b. Changes in Epworth sleepiness scale from baseline and at 15th & 30th days. c. Changes in Manasabhava scale from baseline and at 15th & 30th days from baseline and at 15th & 30th days. d. Changes in Depression Anxiety and Stress Scale (DASS). Changes in Quality of life (SF36) from baseline and at 15th & 30th daysTimepoint: 0th day, 15th day, 30thday

—

Countries

India

Contacts

Public ContactDrSuhas Kumar Shetty

KAHERs Shri BMK Ayurveda Mahavidyalaya

drsuhasshetty@gmail.com06374894696

Outcome results