| CTRI Number |
CTRI/2025/05/086340 [Registered on: 05/05/2025] Trial Registered Prospectively |
| Last Modified On: |
17/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy
Process of Care Changes
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Pranayama and Shirodhara therapy on sleep |
|
Scientific Title of Study
|
Randomized controlled trial to assess the efficacy of Pranayama and Shirodhara therapy in insomnia subjects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pawan Kumar Singh |
| Designation |
PhD Scholar |
| Affiliation |
Panchakarma Department Faculty of Ayurveda institute of medical Sciences Banaras Hindu University |
| Address |
Panchakarma Department Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
919453731170 |
| Fax |
|
| Email |
pawansingh@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajkala Panchakshari Patil |
| Designation |
Associate Professor |
| Affiliation |
Panchakarma Department Faculty of Ayurveda institute of medical Sciences Banaras Hindu University |
| Address |
Panchakarma Department Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8999201857 |
| Fax |
|
| Email |
rajkalapatil@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Pawan Kumar Singh |
| Designation |
PhD Scholar |
| Affiliation |
Panchakarma Department Faculty of Ayurveda institute of medical Sciences Banaras Hindu University |
| Address |
Panchakarma Department Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
919453731170 |
| Fax |
|
| Email |
pawansingh@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Sir Sunderlal Hospital, Panchakarma Section, Indian Medicine Wing, Banaras Hindu University, Varanasi U.P. India 221005 |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences BHU |
| Address |
Sir Sunderlal Hospital Panchakarma Section Indian Medicine Wing Banaras Hindu University Varanasi U P India 221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajkala Panchakshari Patil |
Sir Sunderlal Hospital |
Sir Sunderlal Hospital Panchakarma Section Indian Medicine Wing Banaras Hindu University Varanasi U P India 221005
Varanasi
UTTAR PRADESH |
9824043686
rajkalapatil@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University Institute of Medical Sciences Institutional Ethics Committee Varanasi 221005 BHU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G470||Insomnia. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Pranayam | PRANAYAMA PRACTICE (Total 45 Minutes)
Name of Practice Duration
Pre-Practice
(Aasan)- 1. Vajrasana up to 10 breath awareness 1 minutes 15 minutes
2. Shashanka Asana & Bhujanga Asana
(3 rounds holding for 10 breaths at each step) 5 minutes
3. Ardha uttanPadasana with both leg
(holding for 10 breaths at each step) 2 minutes
3. Ardha Pawan Mukt asana With Both leg
(holding for 10 breaths at each step) 2 minutes
4. Pawanmukt asana &Setubandha Asana
(holding for 10 breaths at each step) 2 minutes
5. Crocodile variation
(holding for 10 breaths at each step) 3 minutes
Core Practice
(Pranayama) Natural breathing Awareness with concentration of nose in Sukh asana 5 minutes 20 minutes
Bhramari Pranayama 20 Round 10 minutes
Natural breathing with awareness of sensation in head
5 minutes
Post
Practice
(Relaxation) Relax in supine position or in Shava asana with awareness of sensation of whole-body parts 10 minutes
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
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.
|
|
| ExclusionCriteria |
| Details |
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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effect of pranayama and Shirodhara on sleep |
Baseline, 9th days, 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Effect of Pranayama and Shirodhara on quality of life of participants |
After completing procedure for 9 days. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
05/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="3"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an Randomized controlled study to analyse the effect of Pranayama and Shirodhara in 100 selected patients of Insomnia. This study aims to compare the efficacy of both procedures in insomnia.
|