| CTRI Number |
CTRI/2020/09/027759 [Registered on: 11/09/2020] Trial Registered Prospectively |
| Last Modified On: |
08/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Vataj Shiroroga Management With Snehan Nasya (Instillation of medicated oil in Nostrils)And Shirobasti Along With Oral Administration Of Pathyadi Kwath |
|
Scientific Title of Study
|
A CLINICO COMPARATIVE EVALUATION BETWEEN SHIROBASTI AND SNEHAN NASYA ALONG WITH PATHYADI KWATH ORALLY IN THE MANAGEMENT OF VATAJ SHIROROGA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kapadiya Umangkumar Jasvantbhai |
| Designation |
PG Scholar |
| Affiliation |
Government Akhandanand Ayurved college |
| Address |
Upgraded Department of Shalakya Tantra,Govt Akhandanand Ayurved College,Bhadra,Ahmadabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
7990341453 |
| Fax |
|
| Email |
kapadiyaumang16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemangi Shukla |
| Designation |
Professor of Shalakya Tantra Department |
| Affiliation |
Government Akhandanand Ayurved college |
| Address |
Upgraded Department of Shalakya Tantra,Govt Akhandanand Ayurved College,Bhadra,Ahmadabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9825504280 |
| Fax |
|
| Email |
drhemangishukla@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemangi Shukla |
| Designation |
Professor Of Shalakya tantra Department |
| Affiliation |
Government Akhandanand Ayurved college |
| Address |
Upgraded Department of Shalakya Tantra,Govt Akhandanand Ayurved College,Bhadra,Ahmadabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9825504280 |
| Fax |
|
| Email |
drhemangishukla@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt.Akhandanand Ayurved College and Hospital |
|
|
Primary Sponsor
|
| Name |
Govt Akhandanand Ayurved College |
| Address |
Govt Akhandanand Ayurved College Bhadra Laldarvaja Ahmadabad |
| Type of Sponsor |
Research institution and hospital |
|
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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 |
| Kapadiya Umangkumar Jasvantbhai |
Government Akhandanand Ayurved hospital |
Upgraded Department Of Shalakyatantra,Government Akhandanand Ayurved college and hospital,bhadra,Lal darvaja,ahmadabad
Ahmadabad
GUJARAT |
7990341453
kapadiyaumang16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G891||Acute pain, not elsewhere classified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bala Taila Shirobasti with oral administration of pathyadi kwath |
Shirobasti with Bala Taila in two schedule of seven days along with pathyadi kwath orally |
| Comparator Agent |
Bala Taila Snehan Nasya With oral administration of pathyadi kwath |
Snehan Nasya Of Bala taila given by instilling 16 drops in each nostril along with pathyadi kwath orally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically Diagnosed Patient of Vataj Shiroroga |
|
| ExclusionCriteria |
| Details |
Patients having age below 18Yrs and above 60 years
Shirobasti Ayogya
Nasya Ayogya
Chronic sinusitis
Referred headache from the ear, nose, eye and teeth.
Secondary headache caused by meningitis, tumor, encephalitis, increase intra ocular Pressure, cervical spondylosis, hypoglycemia.
Migraine
Cerebral Haemorrhagic condition
Brain injury
Hydrocephalus
Stroke
Hypertension
Pregnancy
Neurological conditions: e.g. Trigeminalneuralgia
Any other serious systemic illness.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Management of Vataj shiroroga relieves the Symptoms of Vataj Shiroroga |
After the Completion of the treatment follow up of patient will be for 30 days with the interval of 15 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Grading System of Vataj Shiroroga With VAS Criteria |
After Completion of Treatment,Patient Will be Followed Up For 30 days |
|
|
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)
|
17/09/2020 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
This Research Work is Part of MS(Ayu)Degree,The research Work will be Submitted in the form of Dissertation.Publication:Nil
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare the efficacy of bala taila Shirobasti and bala taila Snaihik Nasya in the management of the Vataj Shiroroga is the main objective of the main objective of the Study.Patients will be Selected from Government Akhandanand Ayurved Hospital and Smt.Maniben Ayurved Hospital.They will be Treated with Bala Taila Shirobasti And Bala Taila Snehan Nasya Along With Pathyadi Kwath Orally.The Patients Will be assessed through VAS Criteria and other grading pattern.This Result will be analysed through Statistical Tests That will be required.
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