Effect of Pranayama and Shirodhara therapy on sleep

Randomized controlled trial to assess the efficacy of Pranayama and Shirodhara therapy in insomnia subjects - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/086340

Enrollment

100

Registered

2025-05-05

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

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. Patients Diagnosed with mild to moderate Insomnia based on DSM criteria -IV at the time of screening. 2. Habitual bedtime between 9:00 pm and midnight. 3. Able and willing to follow all study related instructions and to make all required visits. 4. Insomnia severity index score between 10-15. 5.The subjects who agreed to sincerely follow the instructions given during protocol were included in the study.

Exclusion criteria

Exclusion criteria: 4.6.1 Study related: 1. Patients with substance abuse (excluding tobacco, alcohol), severe depressive, psychotic or bipolar disorder with significant suicide risk. 2. Patient diagnosed other primary sleep disorders (Obstructive sleep apnea (OSA), Restless legs syndrome (RLS) and circadian rhythm sleep disorders etc.) will be excluded from study. 3. Patients having sleep schedule changes associated with shift work or night shifts in previous 7 days before study initiation or who intend to do the same during the study period. 4. Patients with clinically significant uncontrolled endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, hematological or neurological illness. 5. Patients with history of malignancy, seizures or significant head trauma. 6. Pregnant or lactating women. 7. Patients in whom another investigational drug was used within three months prior to entry in this study. 8. Subjects otherwise judged by investigator or co- investigator to be inappropriate for inclusion in the study. 9. Those with age less than 18 yrs. and more than 60 yrs. 4.6.2. Pranayama related: 1. Patient who are not able to sit comfortably for 20 minutes on ground due to any physical abnormality of pathology. 3. Patient not willing to follow the code of conduct of Yoga (Yama-Niyam) 4. Patients with marked deafness. 5. Patient not able to follow verbal instructions. 4.6.3 Shirodhara therapy related: 1. Patients with any injury overhead / neck, presence of an open wound / abrasion on over forehead & scalp region. 2. Central / peripheral neuropathy. 3. Patients having problems in lying supine for 1 hour. 4. Patients who cannot be relied upon to comply with the therapy procedures or are unwilling to give informed consent.

Design outcomes

Primary

Measure	Time frame
Effect of pranayama and Shirodhara on sleepTimepoint: Baseline, 9th days, 30th day	—

Secondary

Measure	Time frame
Effect of Pranayama and Shirodhara on quality of life of participantsTimepoint: After completing procedure for 9 days.	—

Countries

India

Contacts

Public ContactPawan Kumar Singh

Panchakarma Department Faculty of Ayurveda institute of medical Sciences Banaras Hindu University

rajkalapatil@bhu.ac.in8999201857

Outcome results