| CTRI Number |
CTRI/2021/07/034627 [Registered on: 06/07/2021] Trial Registered Prospectively |
| Last Modified On: |
04/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to evaluate the safety and efficacy of MIGSPRAY (nasal spray) in the prevention of episodic migraines in Migraine patients. |
|
Scientific Title of Study
|
A Randomized, Double blind, Clinical Trial to evaluate the safety and efficacy of MIGSPRAY (nasal spray) in the prevention of episodic migraines in Migraine patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Mig/OBS/2021 Version: 1.0; Dated: 13 Feb 2021 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Sadgune |
| Designation |
overall Trial Coordinator |
| Affiliation |
Mudra Clincare |
| Address |
1st Floor, Department of Medicine Awaskar
Building, Pen, Raigad,
Maharashtra.
Mumbai (Suburban)
MAHARASHTRA
Raigarh
MAHARASHTRA
402107
India |
| Phone |
8291745386 |
| Fax |
|
| Email |
mudraclincare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Sadgune |
| Designation |
overall Trial Coordinator |
| Affiliation |
Mudra Clincare |
| Address |
1st Floor, Awaskar Department of Medicine
Building, Pen, Raigad,
Maharashtra.
Mumbai (Suburban)
MAHARASHTRA
Raigarh
MAHARASHTRA
402107
India |
| Phone |
8291745386 |
| Fax |
|
| Email |
mudraclincare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Sadgune |
| Designation |
overall Trial Coordinator |
| Affiliation |
Mudra Clincare |
| Address |
1st Floor, Awaskar Department of Medicine
Building, Pen, Raigad,
Maharashtra.
Mumbai (Suburban)
MAHARASHTRA
Raigarh
MAHARASHTRA
402107
India |
| Phone |
8291745386 |
| Fax |
|
| Email |
mudraclincare@gmail.com |
|
|
Source of Monetary or Material Support
|
| VITROBIO SAS ZAC de Lavaur 63500 Issoire, France |
|
|
Primary Sponsor
|
| Name |
VITROBIO SAS |
| Address |
VITROBIO SAS ZAC de Lavaur 63500 Issoire, France |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Mudra Clincare |
1st Floor, Awaskar
Building, Pen, Raigad,
Maharashtra.
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vaibhav Joshi |
Dnyaneshwari Clinic and Hospital |
Department of Medicine
1st Floor, Awaskar
Building, Pen
Raigarh
MAHARASHTRA |
9004757987
drvaibhavj1980@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Altezza Institutuional Ethics Committe, Shree Ashirwad Hospital, Dombivli, ,Maharshtra, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:G43C||Periodic headache syndromes in child or adult. Ayurveda Condition: k, kha, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MIGSPRAY nasal spray |
Duration 56 days
Route - Nasal Spray
|
| Comparator Agent |
Placebo nasal spray |
Duration 56 days
Route - Nasal Spray |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients having greater than 1-year history of episodic, migraine (with or without aura) with onset prior to 50 years of age, according to diagnostic criteria established by the International Headache Society.
2 Migraine history during the prior 6 months must include:
a at least 4 migraines per month
b no more than 15 migraines per month
c Women of child-bearing potential must not be pregnant, must agree to avoid pregnancy and use an acceptable double-barrier method of birth control during the trial.
3 Willing and able to treat a minimum of 4 migraines per month with study medication and consistently complete Diary for up to 12 weeks.
4 Patient who has not been using a prophylaxis treatment for at least two months prior to the start of the study.
|
|
| ExclusionCriteria |
| Details |
Patients, >50 years old at migraine onset
Pregnant or nursing patients
Abuse of crisis treatment
Patients having history of cluster or hemiplegic headache
Patients having evidence of seizure or major psychiatric disorder
Patients having active chronic pain syndrome
Patients having Cardiac or hepatic disease
Abusing drugs or alcohol
Patients having history of a significant mental disorder
Patients having hypersensitivity/ history of allergy to any of the Investigational product’s components.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the change from baseline in monthly migraine |
at day 65 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Achievement of at least a 50% reduction from baseline in monthly migraine |
at day 65 |
| Change from Baseline in acute migraine-specific medication treatment |
at day 65 |
| Change from Baseline in headache impact scores as measured by the HIT-6 |
at day 65 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
09/07/2021 |
| 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="2"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary
Objective:
§ To assess the efficacy of
MIGSPRAY containing combination of two plants extracts, Salix Alba and
Tanacetum Parthenium in the prevention of episodic migraines in a randomized,
double blind clinical trial.
Secondary
Objective:
To assess the
migraine duration and intensity, and well tolerability of test product. |