CTRI/2024/06/068686 [Registered on: 11/06/2024] Trial Registered Prospectively
Last Modified On:
24/07/2025
Post Graduate Thesis
No
Type of Trial
PMS
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
To observe safety of Vasograin (a combination of Ergotamine, Paracetamol, Prochlorperazine, and Caffeine) for treating migraines in adults: an open study where all participants receive the same treatment.
Scientific Title of Study
To Evaluate efficacy and tolerability of Vasograin ( Ergotamine 1 mg plus Paracetamol 250 mg plus Prochlorperazine 2.5 mg plus Caffeine 100 mg) in adult patients in the treatment of acute migraine: An Open label, Non-randomized, Single arm Clinical Trial
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CT-24-005, Version 1.0 dated 30 Apr 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Dimple Shah
Designation
Head- Medical Affairs
Affiliation
Zyfis Lifesciences Private Limited
Address
ZYFIS LIFESCIENCES PVT. LTD
Address: 511, Silver Radiance 2, Nr. Shakti Arcade, Science City Rd, Sola, Ahmedabad
Ahmadabad GUJARAT 380060 India
Phone
8866662183
Fax
Email
dimple.shah@zyfis.in
Details of Contact Person Scientific Query
Name
Dr Dimple Shah
Designation
Head- Medical Affairs
Affiliation
Zyfis Lifesciences Private Limited
Address
ZYFIS LIFESCIENCES PVT. LTD
Address: 511, Silver Radiance 2, Nr. Shakti Arcade, Science City Rd, Sola, Ahmedabad
Ahmadabad GUJARAT 380060 India
Phone
8866662183
Fax
Email
dimple.shah@zyfis.in
Details of Contact Person Public Query
Name
Pravin Goswami
Designation
Project Manager
Affiliation
Zyfis Lifesciences Private Limited
Address
ZYFIS LIFESCIENCES PVT. LTD.,
Address: 511, Silver Radiance 2, Nr. Shakti Arcade, Science City Rd, Sola, Ahmedabad
1 tablet at the start of migraine attack; 1 additional tablet every 2 hours, if needed for full relief (Maximum Dose: not more than 4 tablets per day and 10 tablets within a week)
Total duration 7 days
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Patients of both genders.
2. Age older or equal to 18 years.
3. Patients which are experiencing migraine headache as per physician’s clinical judgement.
4. Ability to understand and consent to participate in this clinical research, expressed by signing the Informed Consent Form (ICF).
ExclusionCriteria
Details
1. Hypersensitivity to any of the study drugs.
2. Pregnant or lactating females or female using an oral contraceptives.
3. Patients with clinically significant hepatic or renal disease.
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Pain relief after use of Vasograin
Pre dose, post dose- 2 hours 4 hours, 24 hours and 48 hours
Secondary Outcome
Outcome
TimePoints
Decrease in pain intensity after use of Vasograin
Sustained pain free interval after use of Vasograin
Proportion of patients requiring rescue medication within 24 hours.
Relief from migraine associated symptoms like Nausea/vomiting, Photophobia & Phonophobia: the proportion of patients who are free from migraine associated symptoms like nausea/vomiting, photophobia & phonophobia
At Base line, 2 hrs, 4 hrs, 24 hrs & 48 hrs post dose
Target Sample Size
Total Sample Size="1000" Sample Size from India="1000" Final Enrollment numbers achieved (Total)= "1000" Final Enrollment numbers achieved (India)="1000"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This study aims to evaluate the effectiveness and safety of Vasograin, a combination medication (Ergotamine 1 mg, Paracetamol 250 mg, Prochlorperazine 2.5 mg, Caffeine 100 mg), in treating acute migraines in adults. It will be conducted as an open-label, non-randomized, single-arm clinical trial, the study will include 1000 patients. Eligible participants are adults aged 18 or older, experiencing migraine headaches as diagnosed by a physician, and capable of understanding and consenting to the study. Exclusion criteria include allergies to the study drugs, significant liver or kidney disease, and women who are pregnant, breastfeeding, or using oral contraceptives.
The primary objective is to assess the efficacy of Vasograin in relieving migraine pain, measured by the proportion of patients reporting no headache pain at 2 and 4 hours post-dose, using a 4-point Likert scale. Secondary objectives include evaluating pain intensity reduction at 4 hours, the proportion of patients achieving sustained pain-free intervals (24 and 48 hours), the need for rescue medication within 24 hours, and relief from associated symptoms such as nausea, vomiting, photophobia, and phonophobia at 2 and 4 hours. This comprehensive evaluation aims to determine if Vasograin is an effective and tolerable treatment option for adults suffering from acute migraines.