| CTRI Number |
CTRI/2025/08/092614 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To Evaluate Efficacy of Migreez Tablets and Drops in patient suffering from chronic migrain |
|
Scientific Title of Study
|
Open labelled Prospective Randomized single Arm clinical trial to Evaluate the efficacy and safety of Migreez Tablet and nasal drop in management of Chronic Migrain |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr MM Godbole |
| Designation |
Dean and Medical Superintendent |
| Affiliation |
Yashwant Ayurvedic College |
| Address |
Swasthavritta Department
2nd floor
Yashwant Ayurvedic College Post Graduate Training and Research Centre
Kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
02328224146 |
| Fax |
|
| Email |
yamkodoli@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manasi Maurya |
| Designation |
Assistant manager- Medico marketing |
| Affiliation |
Yashwant Ayurvedic College |
| Address |
Vedistry Pvt. Ltd
Medical Department ,
501-A. 5th Floor
21 Evergreen Industrial Estate
Off E Moses Road Mahalaxmi
Mumbai 400011
Mumbai
MAHARASHTRA
400011
India |
| Phone |
9619528619 |
| Fax |
|
| Email |
drmanasimaurya@vedistry.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T vishala |
| Designation |
Professor |
| Affiliation |
Yashwant Ayurvedic College |
| Address |
Kayachikitsa Department
1st Floor
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli
Kolhapur
MAHARASHTRA
416114
India |
| Phone |
02328224146 |
| Fax |
|
| Email |
yamkodoli@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vedistry Pvt. Ltd
21, Evergreen Industrial Estate
Off E Moses Road, Mahalaxmi
Mumbai 400011 |
|
|
Primary Sponsor
|
| Name |
Vedistry Pvt. Ltd |
| Address |
21 Evergreen Industrial Estate
Off E Moses Road Mahalaxmi
Mumbai 400011 |
| 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 |
| DrM M Godbole |
Yashwant Ayurvedic College Post Graduate Training and Research Centre Kodoli |
Swathavritta Department
2nd floor
Yashwant Ayurvedic College Post Graduate Training and Research Centre
Kodoli
Kolhapur
MAHARASHTRA |
02328 222088
yamkodoli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| YashwantAyurvedicCollege Post Graduate Training and Research Centre 02328 222088 yamkodoli@gmail.com Edit || Delete |
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. Ayurveda Condition: ARDHAVABEDAKAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Migreez Tablet , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Glass of water ), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with having with symptoms of Migraine one sided throbbing headache /Nausea & vomiting Sensitivity to light & sound more than 3 months
Completed the screening process within 3 days prior to randomization
Study participant has understood and signed the informed consent form to participate in the study.
Study participant willing to be available for the entire study period and adhere to protocol requirements as evidenced by signing the informed consent document |
|
| ExclusionCriteria |
| Details |
Complicated and special types of gastritis hemorrhage peptic ulcer cholelithiasis cholecystitis, dysplasia of gastric mucosa or pathological diagnosis of suspected malignant change
Reports any presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, urologic, hepatic, immunologic, endocrine, or neurologic systems or psychiatric disease as determined by the investigator(s).
Pregnant and lactating women;
Had a history of allergy from trial medication;
Subject who has been involved with another experimental trial within the past 30 days from the date of recruitment.
Subjects using over-the-counter or prescription anti-reflux agents (Allopathic, Herbal, Homeopathic, Ayurveda, Unani, Siddha medicines) within the past 14 days from the date of recruitment. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Reduction in migraine pain intensity over 30 days by a validated pain scale
2.Decrease in the number of migraine episodes per week over 30 days
3.Reduction in the occurrence of nausea, vomiting, photophobia, and phono phobia over 30 days
4.Time to significant relief from acute migraine pain over 30 days |
1 Visit 1 Baseline
2 Visit 2 Day 15
3 Visit 3 Day 30
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety of Migreez Tablet & Drop in chronic migraine patients. |
1 Visit 1 Baseline
2 Visit 2 Day 15
3 Visit 3 Day 30 |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/08/2025 |
| Date of Study Completion (India) |
10/11/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drmanasimaurya@vedistry.com].
- For how long will this data be available start date provided 31-03-2025 and end date provided 25-10-2042?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Migraine is a neurological condition characterized by recurring episodes of moderate to severe headaches, often accompanied by other symptoms like nausea, vomiting, and sensitivity to light (photophobia) or sound (phonophobia). Migraines may be preceded by an aura, which includes visual disturbances or other sensory changes. It is more than just a headache, involving complex interactions in the brain that lead to pain and other symptoms. The Migreez tablets & Nasal drops are Ayurvedic formulations designed to relieve one sided throbbing headache, Nausea & vomiting, Sensitivity to light & sound. This trial aims to document the efficacy and safety of Migreez Tablets & Drops in relieving migraine associated pain & headache, other symptoms like nausea, vomiting and sensitivity to light and sound, in individuals suffering from chronic migraine. |