| CTRI Number |
CTRI/2019/05/018980 [Registered on: 07/05/2019] Trial Registered Retrospectively |
| Last Modified On: |
03/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ayurvedic Treatment in refractory and chronic migraine patients |
|
Scientific Title of Study
|
Randomized controlled clinical trial to evaluate prophylactic properties of Ayurvedic Treatment Protocol in refractory and chronic migraine patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manjari Tripathi |
| Designation |
Additional Professor |
| Affiliation |
AIIMS |
| Address |
Room No. 705, 7th Floor
Department of Neurology
CNC Centre
AIIMS
Delhi
New Delhi
DELHI
110029
India |
| Phone |
911126594494 |
| Fax |
011-26588248 |
| Email |
mtripathiaiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manjari Tripathi |
| Designation |
Additional Professor |
| Affiliation |
AIIMS |
| Address |
Room No. 705, 7th Floor
Department of Neurology
CNC Centre
AIIMS
Delhi
New Delhi
DELHI
110029
India |
| Phone |
911126594494 |
| Fax |
011-26588248 |
| Email |
mtripathiaiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manjari Tripathi |
| Designation |
Additional Professor |
| Affiliation |
AIIMS |
| Address |
Room No. 705, 7th Floor
Department of Neurology
CNC Centre
AIIMS
Delhi
New Delhi
DELHI
110029
India |
| Phone |
911126594494 |
| Fax |
011-26588248 |
| Email |
mtripathiaiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ipca Laboratories Limited |
|
|
Primary Sponsor
|
| Name |
Ipca Laboratories Limited |
| Address |
142-AB
Kandivli Industrial Estate
Kandivli(W)
Mumbai- 400067 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Manjari Tripathi |
All India Institute of Medical Sciences |
Room No. 705, 7th Floor,
CN Centre,
AIIMS, New Delhi
New Delhi
DELHI |
01126594494
mtripathiaiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee,All India Institute of Medical Sciences, Room no 102, 1st floor, Old OT block, Ansari nagar, New Delhi-110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ayurvedic Treatment protocol |
We will give Ayurvedic Treatment to refractory migraine patients, who will be already on conventional treatment. Two drugs will be administered on BD basis, one drug on OD basis and the fourth drug on TDS basis, for a continuous period of 120 days.the administration of all four drugs will be oral. |
| Comparator Agent |
Conventional Treatment |
We will give conventional treatment to refractory migraine patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Male or Female patients age 18-65 years |
|
| ExclusionCriteria |
| Details |
Patients having migraine with aura, sinusitis induced headache, patients with refractory headache, post traumatic headache, medication over use headache, intracranial hypertension/hypotension and neuralgias and patient with pseudo refractory migraines |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in number of headache days |
The Aurvedic treatment protocol will be given for 120 days and the patients will be then followed up every month for the next 360 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy in reducing the intensity and frequency of pain and associated symptoms on migraine patients by using modern scientific parameters (VAS & MIDAS) |
7 visits to complete 1 year |
|
|
Target Sample Size
|
Total Sample Size="154"
Sample Size from India="154"
Final Enrollment numbers achieved (Total)= "157"
Final Enrollment numbers achieved (India)="157" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/05/2012 |
| Date of Study Completion (India) |
18/01/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Randomized controlled trial to assess the
efficacy of Ayurvedic treatment in migraine patients. It is being conducted in
All India Institute of Medical Sciences. The primary objective of this study is
to assess the efficacy of Ayurvedic treatment to bring long term remission
amongst migaraine patients.The secondary objective of the study is to assess
the efficacy in reducing the intensity and frequency of pain and associated
symptoms on migraine patients by using modern scientific parameters (VAS &
MIDAS) |