| CTRI Number |
CTRI/2025/07/090607 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
29/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Brahmi Taila Shirobasti on insomnia |
|
Scientific Title of Study
|
Single arm clinical trial for assessing the efficacy of Brahmi Siddha Taila Shirobasti in the management of Nidranash |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Pranali Rajendra Parmaj |
| Designation |
PG Scholar, Panchkarma Department |
| Affiliation |
Csmss Ayurvedic Mahavidyalaya and Rugnalaya Kanchanwadi, Aurangabad |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi,431011
Aurangabad
OPD no-15 of Panchkarma Department, CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi 431011 Aurangabad
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9922544896 |
| Fax |
|
| Email |
pranaliparmaj1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Megha Survase |
| Designation |
Associate Professor |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Aurangabad |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi 431011
Aurangabad
OPD No-15 of Panchkarma Department, CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi 431011
Aurangabad
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
8149888802 |
| Fax |
|
| Email |
drmegha26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranali Rajendra Parmaj |
| Designation |
PG Scholar Panchkarma Department |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi 431011
Aurangabad
OPD NO 15, Panchkarma Department, CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Aurangabad 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9922544896 |
| Fax |
|
| Email |
pranaliparmaj1999@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dravyaguna
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011 |
|
|
Primary Sponsor
|
| Name |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad |
| Address |
Panchkarma Department Chhatrapati Shahu Maharaj Shikshan Sanstha Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi, Aurangabad 431011 |
| Type of Sponsor |
Private medical college |
|
|
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 Pranali Rajendra Parmaj |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad |
OPD NO-15 Of Panchkarma Department CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011
Aurangabad
MAHARASHTRA |
9922544896
pranaliparmaj1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F01-F99||Mental, Behavioral and Neurodevelopmental disorders. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Shirobasti | (Procedure Reference: Charak and Shushrut Samhita , Procedure details: Shirobasti with lukewarm Brahmi Siddha Taila for 53 minutes )
(1) Medicine Name: Brahmi Siddha Taila , Reference: Sharangdhar Madhyam khanda , Route: Topical, Dosage Form: Taila, Dose: 1500(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Athens Insomnia scale will be used to diagnose Insomnia with score below 7 |
|
| ExclusionCriteria |
| Details |
Patient below age group of 18 and above 60
Difficulty in sleeping due to medical condition like psychiatric disordered or any neurological disorder
Pregnant and lactating mothers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in sleep time deep and relax sleep |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Activaly do day today activity & sleep cycle improve |
1 Week |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
18/07/2025 |
| 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="1"
Months="6"
Days="0" |
|
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
|
Ayurveda mainly focuses to follow the principales of trayopstambha.The word trayopstambha itself describes trayo means three and upastambha means supportive pillars.The three upstambha of life are aahar,nidra,bramhacharya.If they are maintained and followed appropriately,they maintain the body strongly.Nidra plays a vital role in maintaining health. Nidra is super important for your body and mind.Now a days people are suffering from Nidranash.Prevelence rate of Nidranash is 10% worldwide. Ayurveda has wonderful treatment to treat Nidranash. Aacharya Vagbhata explains moordhni taila.Shirobasti is the best to treat Nidranash.Brahmi magically balance vatat and kapha doshas and it is best to treat the Nidranash.
Study will be conducted on 63 diagnosed patients of Nidranash
Informed written consent will be taken
Initial assessment
Enrollment of patients
Follow up and outcome assessment will be done
Statistical Analysis
Result
Conclusion
|