| CTRI Number |
CTRI/2019/03/018000 [Registered on: 08/03/2019] Trial Registered Prospectively |
| Last Modified On: |
07/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
MANAGEMENT OF ARDHAVBHEDAKA (MIGRAINE) WITH AYURVEDIC MANAGEMENT |
|
Scientific Title of Study
|
“Management of Ardhavbhedaka (Migraine) with Tilkalkadi Shirolepa along with Pathyadi Kwath and Pathyadi Kwath Alone – an open Labelled Randomized comparative Clinical Trial†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sejal Dinubhai Gamit |
| Designation |
P.G Scholar |
| Affiliation |
Government Akhandanand Ayurvedic College, Ahmadabad |
| Address |
Upgraded Department Of Shalakya Tantra, Govt. Akhandanand ayurved College ,
Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
7202807408 |
| Fax |
|
| Email |
seju2291@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Varshaben Chaudhari |
| Designation |
Assistant Professor |
| Affiliation |
Government Akhandanand Ayurvedic College Ahmadabad |
| Address |
Upgraded Department Of Shalakya Tantra, Govt. Akhandanand ayurved College,
Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9328083435 |
| Fax |
|
| Email |
ashavarsha_tarak@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Vd Varshaben Chaudhari |
| Designation |
Assistant Professor |
| Affiliation |
Government Akhandanand Ayurvedic College Ahmadabad |
| Address |
Upgraded Department Of Shalakya Tantra, Govt. Akhandanand ayurved College,
Bhadra Ahmedabad
Ahmadabad
GUJARAT
380001
India |
| Phone |
9328083435 |
| Fax |
|
| Email |
ashavarsha_tarak@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Government Akhandanand Ayurvedic College and Hospital Ahmadabad |
|
|
Primary Sponsor
|
| Name |
Government Akhandanand Ayurvedic college |
| Address |
Bhadra Ahmedabad |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sejal Gamit |
Government Akhandanand Ayurvedic Hospital |
Upgraded Department Of Shalakya Tantra, Govt. Akhandanand ayurved College,
Bhadra Ahmedabad
Ahmadabad
GUJARAT |
7202807408
seju2291@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: G439||Migraine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pathyadi kwath |
40ml Pathyadi kwath with sahpan of Gud (jaggery) twice a day before meal for 30 consecutive days |
| Intervention |
Tilkalkadi Shirolepa along with Pathyadi kwath |
Tilkalkadi Shirolepa application on kapal pradesh in evening once in a day and 40ml Pathyadi kwath with sahpan of Gud (jaggery) twice a day before meal for 30 consecutive
days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients having classical features of Ardhavbhedaka as well as Migraine in modern medical Science. |
|
| ExclusionCriteria |
| Details |
Patient having headache due to any other pathologies except Migraine, complicated Migraine, Migraine with aura, Familial Hemiplegic Migraine (FHM).
Patients Taking any kind of medications of headache.
Patients having any critical condition and suffering from any General Debilitating Health condition.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Management of Ardhavbhedaka( Migraine)and improve releave the symptom of Ardhavbhedaka (Migraine). |
2 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gradation of Ardhavbhedaka as well as Migraine on their severity and grading pattern of HIT-6 |
After treatment completion the patient will be followed for 1 month at the interval of 15 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)
|
11/03/2019 |
| 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 a part of education of MS (Ayurveda) degree, The research work will be
submitted in the form of dissertation and all rights regarding its publication will be reserved by
Gujarat Ayurveda University, Jamnagar. Research Article on the therapy will be made and
published in indexed journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To Study Comparative Efficacy of Tilkalkadi Shirolepa Along With Pathyadi Kwath and Pathyadi Kwath Alone In Ardhavbhedaka (Migraine) Is the Main Objective of This Study. Patients Will Be Selected From Government Akhandanand Ayurveda Hospital, Ahmadabad and Smt. Maniben Ayurveda Hospital Asarva, Ahmadabad after the Conformation of the Diagnosis Of Ardhavbhedaka with the Help of Clinical Features of Ardhavbhedaka (Migraine). They Will Be Treated With Tilkalkadi Shirolepa And Pathyadi Kwath As Mentioned In The Classical Text Books. The Patients Assessment Will Be Carried Out On The Basis Of Scoring And Grading System Of Clinical Features Of Ardhavbheaka (Migraine). The Result Will Be Analysed Through Student T Test And Other Statistical Tests That Will Be Required. |