| CTRI Number |
CTRI/2018/09/015763 [Registered on: 19/09/2018] Trial Registered Prospectively |
| Last Modified On: |
30/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To see the effect of Shirobasti(Pooling of oil on head),Shirodhara(Pouring warm oil over the head for a period of time), Shiropichu(cotton dipped with warm medicated oil kept over head) and Shiroabhyanga(Head Massage with medicated oil) with Lakshadi Taila(Medicated oil) in Nidranash(Insomnia). |
|
Scientific Title of Study
|
“An Open Randomized Comparative Clinical Study on the types of Murdha Taila in the management of Nidranash (Insomnia).†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nidhi Gupta |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda,Jaipur |
| Address |
PG Department of Panchakarma National Institute of Ayurveda Madhav vilas palace, Near Jorawer singh gate, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9691226829 |
| Fax |
|
| Email |
drnidhigupta.20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gopesh Mangal |
| Designation |
Assistant professor and Head |
| Affiliation |
National Institute of Ayurveda,Jaipur |
| Address |
PG Department of Panchakarma National Institute of Ayurveda Madhav vilas palace, Near Jorawer singh gate, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
8619849011 |
| Fax |
|
| Email |
gmangal108@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nidhi Gupta |
| Designation |
PG Scholar |
| Affiliation |
National Institute of Ayurveda,Jaipur |
| Address |
PG Department of Panchakarma National Institute of Ayurveda Madhav vilas palace, Near Jorawer singh gate, Jaipur
Jaipur
RAJASTHAN
302002
India |
| Phone |
9691226829 |
| Fax |
|
| Email |
drnidhigupta.20@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda
Madhav vilas palace, Near Jorawer singh gate
Jaipur 302002 , Rajasthan |
|
|
Primary Sponsor
|
| Name |
National institute of Ayurveda |
| Address |
PG Department of Panchakarma National Institute of Ayurveda Madhav vilas palace, Near Jorawer singh gate |
| Type of Sponsor |
Government 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 Nidhi Gupta |
National Institute of Ayurveda |
Madhav vilas palace, Near Jorawer singh gate,Jaipur
Jaipur
RAJASTHAN |
9691226829
drnidhigupta.20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, National Institute of Ayurvedat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Group A- Shirobasti with Lakshadi Taila in the dose of 2.5 Litre continuously for 7days |
| Intervention |
Group B |
Group B- Shirodhara with Lakshadi Taila in the dose of 2.5Litre continuously for 7days
|
| Intervention |
Group C |
Group C- Shiropichu with Lakshadi Taila in the dose of 350ml continuously for 7days
|
| Intervention |
Group D |
Group D - Shiroabhyanga with Lakshadi Taila in the dose of 210ml continuously for 7days
|
| Comparator Agent |
NOT |
Not |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A. Patients between 16-60 years of age.
B. Patients with clinical signs and symptoms of
Nidranash.(Insomnia)
C. Patients of Insomnia with mild hypertension,mild depression and anxiety disorders without any complications of any other diseases were included for the present study.
D.Patients of either sex irrespective of their occupation, religion and socio-economic status.
E.Patients willing to sign consent form for trial. |
|
| ExclusionCriteria |
| Details |
1.Patients suffering from severe systemic disorders as Uncontrolled Diabetes Mellitus, Uncontrolled Hypertension,Cardiac Problem, Tuberculosis, Leprosy, Paralysis, Malignantdiseases |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Shirobasti, Shirodhara, Shiropichu and Shiroabhyanga.
are effective in management of Nidranash (Insomnia) and Improvement in the symptoms of the Patient.
|
22 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Any adverse effect in clinical signs and symptoms |
7days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
Date of First Enrollment (India)
Modification(s)
|
01/09/2019 |
| Date of Study Completion (India) |
17/02/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NO |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Shirobasti, Shirodhara, Shiropichu and Shiroabhyanga is included in variety of Murdha Taila. In the
present study Murdha Taila has
been explained in Sushruta Sharir Sthana
in reference to Nidranash along with other diseases. So, Murdha Taila
is selected particularly for Nidranash. Etymology, definition,
indication, contraindication, importance, mode of action etc. and the Poorva
Karma, Pradhana Karma, Pashchata Karma and precautions explained in detail. In this clinical
trial total 42 patients were registered from OPD/IPD of department of
Panchkarma, National Institute of Ayurveda, Jaipur, Rajasthan. Selected
patients were divided randomly with the help of lottery method, into 4 Groups. Out
of 42 patients, 1 patient was drop-out case in Group B due to chronic rhinitis
and 1 patient was drop-out case in Group D due to some family problems before
starting the treatment. Total 40 patients completed the treatment. Following conclusion can be drawn from current
research study- ·
Nidranash being a Vata Nanatmaja Vyadhi, Brinhana
is best therapy and all the types of Murdha Taila are best
recommended in the patient of Nidranash, with the help of Lakshadi
Taila which having Balya, Indriya Prasadana and Nidrajanana
Properties, as all the
procedures are non-invasive, outpatient procedures with minimal discomfort.
- Insomnia
is more commonly seen in middle age group and females are more affected in
this study.
- It
is observed that insomnia manifests mostly in patients who are suffering
from Chinta followed by Shoka.
·
Observations
and results of the present study hold the explanation of the modern and Ayurveda
literatures and also support the result of the previous work done.
- Tandra
(drowsiness), Shirashoola (headache), Angamarda (body ache)
and total PSQI (Pittsburg sleep quality index) parameter found significant
result in all four Groups.
- Jrimbha (yawning) parameter is
found significant result in only Group B and Arati - Klama
(inertness and fatigue) is found significant result in only Group A.
- Jadya
(stiffness) parameter found significant result in Group A and Group B.
- Apkti
(indigestion) parameter found Non- significant result in all four Groups.
- According
to mean rank percentage, Group B (Shirodhara) is more effective
than all Groups.
- In
chronic condition may need long term therapy for better results and to
remove occurrence and repeated Murdha Taila after the assessing the patient may be
the best choice for the management of Nidranash (insomnia)
·
Thus, it is concluded that the“Types
of Murdha Taila are effective in the management of Nidranash
(insomnia)â€.
|