| CTRI Number |
CTRI/2024/01/062138 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
24/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical study to compare the effect of four types of murdhini taila with
ksheerabala thailam in primary insomnia. |
|
Scientific Title of Study
|
A clinical study to compare the effect of
murdhini taila with ksheerabala thailam in primary 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 |
DrKeerthana Varghese |
| Designation |
PG Scholar |
| Affiliation |
AMRITA SCHOOL OF AYURVEDA |
| Address |
Amrita School Of Ayurveda,
Amritapuri,
Clappana P.O,
Kollam
Kerala
Amrita School Of Ayurveda,
Amritapuri,
Clappana P.O,
Kollam
Kerala
Kollam
KERALA
690525
India |
| Phone |
08304907509 |
| Fax |
|
| Email |
keerthanatvarghese@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishnu U |
| Designation |
Assosiate professor |
| Affiliation |
AMRITA SCHOOL OF AYURVEDA |
| Address |
Amrita School Of Ayurveda,
Amritapuri,
Clappana P.O,
Kollam
Kerala
Amrita School Of Ayurveda,
Amritapuri,
Clappana P.O,
Kollam
Kerala
Kollam
KERALA
690525
India |
| Phone |
95967198958 |
| Fax |
|
| Email |
pillaidrvishnu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vishnu U |
| Designation |
PG Scholar |
| Affiliation |
AMRITA SCHOOL OF AYURVEDA |
| Address |
Amrita School Of Ayurveda,
Amritapuri,
Clappana P.O, Kollam, Kerala
Amrita School Of Ayurveda,
Amritapuri,
Clappana P.O,
Kollam
Kerala
Kollam
KERALA
690525
India |
| Phone |
95967198958 |
| Fax |
|
| Email |
pillaidrvishnu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School Of Ayurveda
Amritapuri,
Clappana P.O
Vallickav
Kollam
Kerala |
|
|
Primary Sponsor
|
| Name |
DrKeerthana Varghese |
| Address |
Amrita School of Ayurveda,
Amritapuri,
Clappana P.O
Vallickav,
Kollam
Kerala |
| Type of Sponsor |
Other [self] |
|
|
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 Keerthana Varghese |
Amrita School Of Ayurveda,Amritapuri |
Depatment of Panchakarma,First floor,room no:1
Kollam
KERALA |
08304907509
keerthanatvarghese@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amrita Centre for Advanced Research in Ayurveda |
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 | Procedure | - | four types of murdhini taila | (Procedure Reference: Astanga hrdaya, Procedure details: Shiroabhyanga 7days
shiroseka 7days
shiropichu 7days
shirovasti 7days)
|
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients between the age group of 30-50 years irrespective of gender.
2. Patients with primary insomnia for at least 1 month duration.
3. Patients diagnosed with insomnia as per DSM IV with an ISI Score more than 15. |
|
| ExclusionCriteria |
| Details |
1. Patients contraindicated for murdhini taila.
2. Sleep disturbance due to narcolepsy, breathing-related sleep disorder, circadian
rhythm sleep disorder, or a parasomnia.
3. Sleep disturbance occurring during the course of another mental disorder (e.g.,
major depressive disorder, generalized anxiety disorder, a delirium).
4. Patients under medication for insomnia.
5. Patients with alcohol dependence or drug dependency |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| will be the change in severity of insomnia according to insomnia severity index scale |
0 Screening ,diagnosis
Assessment with ISI and PSQI
1-7th day procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
will be change in quality of sleep according to patient
reported PQSI. |
8th day -final assessment
14th day-follow up |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
03/02/2024 |
| 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
|
INCLUSION 1.Patients between the age group of 30-50 years irrespective of gender. 2. Patients with primary insomnia for at least 1 month duration. 3. Patients diagnosed with insomnia as per DSM IV with an ISI Score more than 15.
EXCLUSION 1. Patients contraindicated for murdhini taila. 2. Sleep disturbance due to narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder, or a parasomnia. 3. Sleep disturbance occurring during the course of another mental disorder (e.g., major depressive disorder, generalized anxiety disorder, a delirium). 4. Patients under medication for insomnia. 5. Patients with alcohol dependence or drug dependency |