| CTRI Number |
CTRI/2017/07/009135 [Registered on: 27/07/2017] Trial Registered Retrospectively |
| Last Modified On: |
20/07/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study of ayurvedic management of vaata dominant headache vis a vis migraine |
|
Scientific Title of Study
|
A clinical study of ayurvedic management of vatik shiroroga vis a vis migraine |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parth K Patel |
| Designation |
Pg scholar |
| Affiliation |
j s ayurveda mahavidhyalaya |
| Address |
Room no. 1 Kaychikitsha department, P D Patel Ayurveda Hospital, J S Ayurveda college,
College road, Nadia
Room no. 1 Kaychikitsha department, P D Patel Ayurveda Hospital, J S Ayurveda college,
College road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8469148243 |
| Fax |
2520646 |
| Email |
patelparth19910@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish V Patel |
| Designation |
Reader |
| Affiliation |
j s ayurveda mahavidhyalaya |
| Address |
Room no. 1 Kaychikitsha department, P D Patel Ayurveda Hospital, J S Ayurveda college,
College road, Nadiad
Room no. 1 Kaychikitsha department, P D Patel Ayurveda Hospital, J S Ayurveda college,
College road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
9979589865 |
| Fax |
2520646 |
| Email |
manishayu97@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parth K Patel |
| Designation |
Pg scholar |
| Affiliation |
j s ayurveda mahavidhyalaya |
| Address |
Room no. 1 Kaychikitsha department, P D Patel Ayurveda Hospital, J S Ayurveda college,
College road, Nadiad
Room no. 1 Kaychikitsha department, P D Patel Ayurveda Hospital, J S Ayurveda college,
College road, Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
8469148243 |
| Fax |
2520646 |
| Email |
patelparth19910@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no. 1 Kaychikitsha department, P D Patel Ayurveda Hospital, J S Ayurveda college,
College road, Nadiad |
|
|
Primary Sponsor
|
| Name |
j s ayurved mahavidhyalaya |
| Address |
Room no. 1 Kaychikitsha department, P D Patel Ayurveda Hospital, J S Ayurveda college,
College road, Nadiad |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| j s ayurveda mahavidhyalaya |
Room no. 1 Kaychikitsha department, P D Patel Ayurveda Hospital, J S Ayurveda college,
College road, Nadiad |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Parth K Patel |
j s ayurved mahavidhyalaya |
PG department Kayachikitsha division room no 1 P D Patel ayurved hospital college road nadiad
Kheda
GUJARAT |
8469148243
2520646
patelparth19910@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee for human reasearch |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
patient suffering with migraine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
not applicable |
not applicable |
| Intervention |
Pathyadi Kwatha,shirahshuladri vajra rasa,nasya karma
|
pathyadi kwath
dose 40ml two times per day empty stomach
Pathya Aksa Dhatri Bhunimba Nisha Nimba Amruta,
shirahshuldri vajra rasa
500mg one tds after meal with madhu
sudhha parada sudhha gandhaka Loha bhasma Tamra bhasma sudhha Guggulu Triphala churna Yastimadhu Pippali churna Sunthi churna Goksura churna Vidanga churna Dasamula churna Dasamula kwatha Gaughrta
nasya karma with narayana oil 8 drops each nostril at morning for 2 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinical features of vatika shiroroga (migraine) as mentioned in diagnostic criteria.
2.Patients between the age group of 18 to 60 years.
|
|
| ExclusionCriteria |
| Details |
1.Patient on corticosteroids and who received psycho pharmacological agents in last 6 months.
2.Pregnant and lactating women.
3.Patient having any other clinical condition i.e. diabetes, hyperthyroidism, hypothyroidism, cardiovascular disease, tuberculosis, Parkinsion’s disease and Patients suffering from sinusitis, hypertension and fever, secondary headache caused by meningitis, tumor, encephalitis, cervical spondylitis and refractive errors; also patients using any other systemic drugs which may alter the results of the study will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Notify improvement sign and symptoms and laboratory investigation in the patients |
the outcome wil be assesed after 19 days of treatment in comperision to before treatment measure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/01/2017 |
| 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="17"
Months="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
The research work is a part of postgraduation study hence it will be published in the form of disseration |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
For a clinical study patients fulfilling the inclusion criteria will be carried from out patient department (O.P.D) and in patient department (I.P.D.) department of P.D. Patel Ayurveda hospital Nadiad for the present study irrespective of demographical divison .Detailed history will be taken according to the proforma prepared for the study incorporating all the relevant points from both Ayurveda and modern medical science.
|