| CTRI Number |
CTRI/2025/07/091841 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
25/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Study Efficacy of Til tail padabhyanga versus Anu Tail nasya in Anidra. |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial to Study the Effect of Taila Padabhyanga in Anidra Caused by Prolonged Screen Time with Reference to the Pittsburgh Sleep Quality Index. |
| 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 Priyansh Sharma |
| Designation |
PG SCHOLOR |
| Affiliation |
LRP Ayurvedic Medical College Islampur sangli |
| Address |
Swasthavritta Opd Loknete Rajarambapu Patil Ayurvedic Medical College Hospital PG Institute and Research Center Islampur 415409 Dist Sangli
MAHARASHTRA
415409
Sangli
MAHARASHTRA
415409
India |
| Phone |
7030278288 |
| Fax |
|
| Email |
priyanshsharma3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shweta R Nakil |
| Designation |
Associate Professor |
| Affiliation |
LRP Ayurvedic college Islampur Sangli |
| Address |
Swasthavritta Opd Loknete Rajarambapu Patil Ayurvedic Medical College Hospital PG Institute andResearch Center Islampur 415409 Dist. Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9850920891 |
| Fax |
|
| Email |
Shwetanakil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shweta R Nakil |
| Designation |
Associate Professor |
| Affiliation |
LRP Ayurvedic college Islampur Sangli |
| Address |
Swasthavritta Opd Loknete Rajarambapu Patil Ayurvedic Medical College Hospital PG Institute andResearch Center Islampur 415409 Dist. Sangli
Sangli
MAHARASHTRA
415409
India |
| Phone |
9850920891 |
| Fax |
|
| Email |
Shwetanakil@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital Post Graduate Research Centre Islampur 415409 Dist Sangli Maharashtra India |
|
|
Primary Sponsor
|
| Name |
LRP AYURVEDIC COLLEGE ISLAMPUR |
| Address |
Swasthvritta Opd LRP Ayurvedic Medical College Hospital PG Institute Research Centre Islampur 415409 |
| 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 Shweta R Nakil |
LRP AYURVEDIC COLLEGE AND HOSPITAL ISLAMPUR SANGLI |
Swasthavritta Opd ,Lokneta Rajarambapu patil Ayurvedic Medical College Hospital Post Graduate Institute
and Research Center Islampur 415409
Sangli
MAHARASHTRA |
9850920891
Shwetanakil@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Lokanete Rajarambapu patil Ayurvedic Medical College, Hospital, Post Graduate Institute and Research Center, Islampur 415409 |
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 | Drug | Classical | | (1) Medicine Name: TIL tail, Reference: Sushrut Samhita chikitsasthan, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: hs, Bhaishajya Kal: Samudga, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Anu Tail, Reference: Astang Hridaya , vagbhata sutrasthan, Route: Nasal, Dosage Form: Bindu/ Drops (Karna/ Nasa/ Netra), Dose: 2(drops), Frequency: hs, Bhaishajya Kal: Samudga, Duration: 21 Days, anupAna/sahapAna: No, Additional Information: - |
|
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age group 30 to 50 years will be randomly selected for the study
irrespective of their caste, gender, marital status, and economic class
People Working for more than 4 hours daily on computer screen
Patients having Nidranasha lakshanas |
|
| ExclusionCriteria |
| Details |
People of age less than 30 years and more than 50 years of age.
People who work for less than hours on a computer screen. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the effect of practicing Til Tail Padabhyanga in Anidra cause due to
longer screen time observes by reduction in score of PSQI scale. |
21 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the association between working for longer duration on screen and Anidra |
21 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/08/2025 |
| 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="0"
Months="3"
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
|
One of the important components for maintaining balance between body and mind is trayopstambha which includes ahar, nidra and brahmacharya i.e. three supportive pillars of life[3]. Out of which nidra is a very important factor. Sleep plays a vital role in maintaining balance of physical, mental and emotional health of a person. Lack of sleep is termed as insomnia. Understanding the severity of the disease and finding the permanent solution for that is need of an hour. Padabhyanga can be the solution for that. The effect of padabhynga is mentioned in all the three texts of Brihatrayee, have commonly mentioned as dristiprasadana or netraprasadan. In specific disease like anxiety, stress, insomnia padabhyanga done at night hours has good effect[13] Nasya is another solution for the same. Pratimarsha Nasya, one of the type of Nasya procedure[14] is also advocated to be used as a part of Dincharya(daily regimen)[15] Regular practice of Anutaila Nasya regains the sharpness of the sense organs Most of the research studies were conducted to assess only single efficacy of padabhyanga or Nasya procedure, but none of the studies was conducted between til tail padabhyanga and anu tail nasya procedure.
|