| CTRI Number |
CTRI/2025/03/083668 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy
Other (Specify) [Primary Insomnia] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Efficacy of Alternative therapies in the cases of primary insomnia |
|
Scientific Title of Study
|
Efficacy of Yoga therapy (Yog Nidra) and Shirodhara in adults
with Primary Insomnia – A Multi-Centric Randomized Controlled Trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GEETANJALI SAMBHAJI KARLE |
| Designation |
Professor |
| Affiliation |
AYUSH department, MUHS |
| Address |
Maharashtra University of Health Sciences
Dindori road, Nashik
Nashik
MAHARASHTRA
422004
India |
| Phone |
09890767919 |
| Fax |
|
| Email |
geetanjali.anat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
GEETANJALI SAMBHAJI KARLE |
| Designation |
Professor and Head |
| Affiliation |
AYUSH department, MUHS |
| Address |
Maharashtra University of Health Sciences
Dindori road, Nashik
Nashik
MAHARASHTRA
422004
India |
| Phone |
09890767919 |
| Fax |
|
| Email |
geetanjali.anat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GEETANJALI SAMBHAJI KARLE |
| Designation |
Professor |
| Affiliation |
AYUSH department, MUHS |
| Address |
AYUSH Department, Maharashtra University of Health Sciences
Dindori road, Nashik
Nashik
MAHARASHTRA
422004
India |
| Phone |
09890767919 |
| Fax |
|
| Email |
geetanjali.anat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maharashtra University of health Sciences, Nashik, Dindori road, Nashik |
|
|
Primary Sponsor
|
| Name |
Applied for IMR to Maharashtra University of Health Sciences Nashik |
| Address |
Maharashtra University of Health Sciences
Dindori road |
| Type of Sponsor |
Other [Maharashtra University of Health Sciences] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karle Geetanjali |
Prakruti wellness center |
AYUSH Department, Maharashtra University of Health Sciences
Dindori road
Nashik
MAHARASHTRA |
09890767919
geetanjali.anat@gmail.com |
| Dr Sanchita Gour |
SMBT institute of medical sciences and research centre |
Dhamangaon, Igatpuri Nashik
Nashik
MAHARASHTRA |
8237467010
geetanjali.anat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Maharashtra University of Health Sciences, Nashik |
Approved |
| SMBT institute of medical sciences and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F418||Other specified anxiety disorders. Ayurveda Condition: NIDRA-VAISHAMYAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Yog Nidra | Yog Nidra session for 20 minutes | | 2 | Intervention Arm | Procedure | - | Shirodhara and Yog nidra | (Procedure Reference: Samhita , Procedure details: Shirodhara and Yog nidra will be given for 20 minutes each )
(1) Medicine Name: Bramhi , Reference: charak , Route: Topical, Dosage Form: Taila, Dose: 1000(ml), Frequency: od, Duration: 8 Days | | 3 | Comparator Arm (Non Ayurveda) | | - | Etiozolam 0.25 mg od | modern medicine proven drug for insomnia | | 4 | Intervention Arm | Procedure | - | Shirodhara | (Procedure Reference: Samhita , Procedure details: oil drip on forehead for 20 minutes ))
(1) Medicine Name: bramhi oil , Reference: samhita , Route: Topical, Dosage Form: Taila, Dose: 1000(ml), Frequency: od, Duration: 8 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed primary insomnia with complaints of sleep disturbances |
|
| ExclusionCriteria |
| Details |
secondary insomnia Pregnant women
Chronic systemic disorders
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in Sleep quality and sleep duration is primary outcome. Modern medicine is having its own limitations. If it is taken for long duration, it may cause dependency. Insomnia cases may be successfully treated with alternative therapies like Shirodhara and Yognidra. Shirodhara may be most effective treatment for Insomnia. integrative approach may be beneficial for the improvement in Sleep Efficiency. |
first 7 days allotted therapy wlii be given (shirodhara/ yog nidra/ modern medicine) from 8 th day therapy will be stopped and patients only will maintain diary for noting observations regarding Sleep quality and duration up to 15 th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| integrative approach may be beneficial for the improvement in Sleep Efficiency. |
15 days observations will be noted down |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
07/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
07/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 20-03-2025 and end date provided 20-03-2030?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Present study aims to determine the efficacy of Yog Nidra or Shirodhara in the cases of primary insomnia. study will be conducted in four parallel groups- group 1- shirodhara, group 2- Yog nidra, group 3- Shirodhara + yog nidra, group 4- Etiozolam 0.25 mg od. all treatments will be given for 8 days. diary will be given to patient for note down observations from day-1 to day-15 regarding sleep Quality and time. finally results will be drawn based on observations. |