| CTRI Number |
CTRI/2020/03/024176 [Registered on: 23/03/2020] Trial Registered Prospectively |
| Last Modified On: |
25/02/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of Shirodhara in Madatyajanya Anidra |
|
Scientific Title of Study
|
COMPARATIVE CLINICAL STUDY OF TIL TAILA SHIRODHARA AND KSHEER SHIRODHARA IN MADATYAYA JANYA ANIDRA W.S.R.TO ALCOHOL WITHDRAWAL SYNDROME |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Anita Sharma |
| Designation |
Professor and H.O.D. |
| Affiliation |
National Institute of Ayurveda Jaipur (Raj) |
| Address |
Room no. 205 Department of Agad Tantra, National Institute of Ayurveda Jaipur Rajasthan
Pin code- 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414078653 |
| Fax |
|
| Email |
anita31sharma@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Anita Sharma |
| Designation |
Professor and H.O.D. |
| Affiliation |
National Institute of Ayurveda Jaipur (Raj) |
| Address |
Room no. 205 Department of Agad Tantra, National Institute of Ayurveda Jaipur Rajasthan
Pin code- 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9414078653 |
| Fax |
|
| Email |
anita31sharma@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Poonam Sharma |
| Designation |
M.D.Scholar |
| Affiliation |
National Institute of Ayurveda Jaipur (Raj) |
| Address |
Room no. 208 Department of Agad Tantra, National Institute of Ayurveda Jaipur Rajasthan
Pin code- 302002
Jaipur
RAJASTHAN
302002
India |
| Phone |
9459590967 |
| Fax |
|
| Email |
ps149686@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur |
|
|
Primary Sponsor
|
| Name |
National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur |
| Address |
National Institute of Ayurveda Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Poonam Sharma |
National institute of Ayurveda Hospital jaipur |
Room no.25 NIA OPD, Room No. 208 Department of Agad Tantra, National Institute of Ayurveda Jaipur Rajasthan
Pin code- 302002
Jaipur
RAJASTHAN |
9459590967
ps149686@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F101||Alcohol abuse, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Til Taila Shirodhara will be given in 15 patients of Madatyajanya Anidra.
Amount - 1L of oil for Shirodhara
Time Period- 45 minutes
Total Days- 14 days trial with follow up for 14 days.
|
| Comparator Agent |
Group B |
Ksheer Shirodhara will be given in 15 patients of Madatyajanya Anidra.
Amount - 1L of Ksheer for Shirodhara
Time Period- 45 minutes
Total Days- 14 days trial with follow up for 14 days.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed patient of alcohol addiction.
2. Clinical manifestation of insomnia as a alcohol withdrawal syndrome which will be presented at that time.
3. Age between 20-60 years
4. Either sex.
|
|
| ExclusionCriteria |
| Details |
1. Alcohol addicted patients suffering from liver failure, gastrointestinal bleeding, cerebellar degeneration.
2. Alcohol addicted patients who are suffering from major psychiatric disorders like Bipolar disorder.
3. Alcohol addicted patients suffering from major systemic illness like diabetes, hypertension, myocardial infarction, ischemic heart disease, pulmonary tuberculosis etc.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
| Changes in sleep quality |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in Parameters of Madatyaya janya Anidra |
28 days |
|
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Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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 |
|
Date of First Enrollment (India)
|
01/04/2020 |
| 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="0"
Days="28" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This trial will be done to compare clinical efficacy of Til Taila Shirodhara and Ksheer Shirodhara in management of Madatyaya janya anidra with special reference to Alcohol Withdrawal Syndrome. This is an interventional clinical trial with sample size of 30 with 2 groups. Each group having a sample size of 15 patients. In group A Til Taila Shirodhara will be done for duration of 45 minutes for 14 days. The time of administration will be morning (8 -11 AM). In group B Ksheer Shirodhara will be done for duration of 45 minutes for 14 days. The time of administration will be morning (8 -11 AM). The assessment of the clinical response in the total number of patients will be made on : The insomnia assessment criteria, insomnia screening questionnaire, Clinical assessment of alcohol withdrawal Patients (CIWA). Patient will be further followed up on Fourteenth day after the completion of the trial.
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