| CTRI Number |
CTRI/2025/03/082240 [Registered on: 12/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of bufflow milk shirodhara in nidranash |
|
Scientific Title of Study
|
Randomized controlled clinical trail to Evaluate the efficacy of Mahishksheer Shirodhara in Anidra with special reference Stress Induced Insomnia |
| 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 Namankumar Padamkumar Ajmera |
| Designation |
PG Scholar |
| Affiliation |
CSMSS Ayurved Mahavidayala and Rugnalaya kanchanwadi aurangabad 431011 |
| Address |
OPD NO 15 C.S.M.S.S Ayurved Mahavidyala and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
OPD NO.15 PANCHKARMA DEPARMAENT
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7972577835 |
| Fax |
|
| Email |
namanajmera1008@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Megha Survase |
| Designation |
Associate Professor |
| Affiliation |
CSMSS Ayurved Mahavidayala and Rugnalaya kanchanwadi aurangabad 431011 |
| Address |
OPD NO 15 C.S.M.S.S Ayurved Mahavidyala and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
OPD NO.15 PANCHKARMA DEPARMAENT
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
8149888802 |
| Fax |
|
| Email |
drmegha26@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namankumar Padamkumar Ajmera |
| Designation |
PG Scholar |
| Affiliation |
SMSS Ayurved Mahavidayala and Rugnalaya kanchanwadi aurangabad |
| Address |
OPD NO 15 C.S.M.S.S Ayurved Mahavidyala and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011
OPD NO.15 PANCHKARMA DEPARMAENT
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
7972577835 |
| Fax |
|
| Email |
namanajmera1008@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Ayurved Mahavidayala and Rungnalaya Kanchanwadi Aurangabad 431011 |
|
|
Primary Sponsor
|
| Name |
SMSS Ayurved Mahavidayala and Rugnalaya kanchanwadi aurangabad |
| Address |
CSMSS Ayurved Mahavidayala and Rungnalaya 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 |
| Naman Ajmera |
CSMSS Ayurved Mahavidayala and Rungnalaya Kanchanwadi Aurangabad 431011 |
OPD NO 15 Department of panchkarma
Aurangabad
MAHARASHTRA |
7972577835
namanajmera1008@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CSMSS Ayurved Mahavidalaya 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 | Comparator Arm | Procedure | - | shirodhara | (Procedure Reference: charak and shrushrut samhita, Procedure details: shirodhara with luke warm takra for 45 min perday
in oscillatory manner)
| | 2 | Intervention Arm | Procedure | - | Shirodhara | (Procedure Reference: charak and shrusrut samhita, Procedure details: shirodhara with luke warm bufflow milk for 45 min in oscillatory manner )
|
|
|
|
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 18 and above 60
previous psychological disorder Schizophrenia
pregent and lactating mother |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Increase in sleep time
deep n relax sleep |
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Actively do day to day activity |
1 week |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
17/03/2025 |
| 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) |
Open to Recruitment |
|
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 is one of the worlds oldest holistic healing system.
Ayurveda become more and more accepted globally as it is eco-
friendly toxicity free and cost effective due to holistic approach.
Ayurveda is the science which mentioned various principles for
prevention and treatment of disease. Prevention is better than
cure is the basic concept of Ayurveda. Curing a diseased person
and redefining his healthy status, is the primary goal of a physician.
Acharya Sushruta has given Importance to physical health as well as
mental health. If there is a healthy mind in a healthy body, then
only we can say that a person is a healthy. Ayurveda is not only a system of medicine rather it is the way of
life. It includes physical, mental, and spiritual well being.
In Ayurveda Tridoshas i.e. VATA, PITTA , KAPHA are described as
tristambh of ayurveda . Similarly Aahar (Diet), Nidra(Sleep)and
Bramacharya described as tryoupsthmbas.
Acharya Charaka mentioned Ahara, Nidra and Brahmacharya as
three important tripod of life.
The inclusion of Ahara and Nidra in the three Upastambha proves
its importance of sleep.
Null Hypothesis:
Mahishksheer Shirodhara is not effective in Anidra with special
reference to stress induced Insomnia.
Alternate Hypothesis:
Mahishksheer Shirodhara is effective in Anidra with special
reference to stress induced Insomnia
|