| CTRI Number |
CTRI/2019/03/018093 [Registered on: 14/03/2019] Trial Registered Prospectively |
| Last Modified On: |
19/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A comparative study to evaluate effect of dripping of liquid substance on forehead between tila oil and medicated milk in sleeplessness. |
|
Scientific Title of Study
|
A comparative study to evaluate the effect of Bala and Shatavari Siddha Ksheer Shirodhara and Tila Taila Shirodhara in Anidra ( 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 Pooja Rani |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurveda Charak Sansthan, Kheradabar,NajafGarh |
| Address |
Chaudhary Brahm Prakash Ayurveda Charak Sansthan, Kheradabar,NajafGarh
South West
DELHI
110073
India |
| Phone |
8851304239 |
| Fax |
|
| Email |
pathakpooja773@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vishakha Rajesh Wetal |
| Designation |
Associate Professor |
| Affiliation |
Chaudhary Brahm Prakash Ayurveda Charak Sansthan, Kheradabar,NajafGarh |
| Address |
Chaudhary Brahm Prakash Ayurveda Charak Sansthan, Kheradabar,NajafGarh
South West
DELHI
110073
India |
| Phone |
9518528493 |
| Fax |
|
| Email |
vishakhawetal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Rani |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurveda Charak Sansthan, Kheradabar,NajafGarh |
| Address |
Chaudhary Brahm Prakash Ayurveda Charak Sansthan, Kheradabar,NajafGarh
South West
DELHI
110073
India |
| Phone |
08851304239 |
| Fax |
|
| Email |
pathakpooja773@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurveda Charak Sansthan KheradabarNajafGarh |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurveda Charak Sansthan KheradabarNajafGarh |
| Address |
Chaudhary Brahm Prakash Ayurveda Charak Sansthan, Kheradabar,NajafGarh |
| 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 Pooja rani |
Chaudhary Brahm Prakash Ayurveda Charak Sansthan KheradabarNajafGarh |
PG Department of panchakarma,room no.342
South West
DELHI |
8851304239
pathakpooja773@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee- chaudhary brahm prakash ayurveda charak sansthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
bala and shatavari siddha ksheera shirodhara |
bala and shatavari siddha Ksheer will be prepared about 1500ml daily and it will be poured over forehead of the patients and it will be done for 7 days. |
| Comparator Agent |
tila taila |
Tila taila will be poured over the forehead of the patient.For that 1500ml for first three days and
50ml added further when quantity reduced and done till 7 days. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
patients diagnosed as a case of (anidra)chronic insomnia according to clinical features as described in classical text will be selected irrespective of gender and socioeconomic status. |
|
| ExclusionCriteria |
| Details |
patient having any major psychiatric illness, with alcohol dependency, asthma,malignancies, liver cirrhosis, chronic renal failure, or any acute illness. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| insomnia severity index scale |
14 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| scoring adoptive scale for anidra (insomnia) |
14 days |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="126" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/03/2019 |
| Date of Study Completion (India) |
30/07/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/07/2019 |
|
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
Modification(s)
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This study is an open label parallel group trial comparing the effect of bala and shatavari siddha ksheera shirodhara and tila taila shirodhara in anidra (insomnia). In one group patients treatment will be given with bala and shatavari siddha ksheera shirodhara and in another group of patients tila taila shirodhara will be given with primary outcome improvement in sleeplessness assessed on insomnia severity index scale. the study will be conducted in chaudhary brahm prakash ayurveda charak sansthan, PG department of panchkarma room no.342,kheradabar, India. |