CTRI

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CTRI Number

CTRI/2026/01/100901 [Registered on: 12/01/2026] Trial Registered Prospectively

Last Modified On:

10/01/2026

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Single Arm Study

Public Title of Study

A Clinical Study to Assess MIG-T Tablets in Adults with Episodic Migraine

Scientific Title of Study

A Pilot Clinical Study to Evaluate the Safety and Efficacy of MIG-T, Vaidyaratnam’s Herbal Formulation, in the Management of Episodic Migraine

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 Sheela Karalam B
Designation	Chief Scientist
Affiliation	Vaidyaratnam Ayurveda research Institute
Address	R&D Department Room No. 3 Vaidyaratnam Ayurveda Research Institute R&D Department Room No. 3 Vaidyaratnam Ayurveda Research Institute Thrissur KERALA 680306 India
Phone	9446533770
Fax
Email	sheelakaralam@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Remya V
Designation	Senior Scientist
Affiliation	Vaidyaratnam Ayurveda Research Institute
Address	R&D Department Room No. 1 Vaidyaratnam Ayurveda Research Institute R&D Department Room No. 1 Vaidyaratnam Ayurveda Research Institute Thrissur KERALA 680306 India
Phone	9447168329
Fax
Email	remyavmenon@gmail.com

Details of Contact Person
Public Query

Name	Dr Dileep K S
Designation	Consultant
Affiliation	Vaidyaratnam Ayurveda Foundation Hospital
Address	Room No. 2 Vaidyaratnam Ayurveda Foundation Hospital Room No. 2 Vaidyaratnam Ayurveda Foundation Hospital Thrissur KERALA 680306 India
Phone	9961045901
Fax
Email	dileepkshankar@gmail.com

Source of Monetary or Material Support

NIL

Primary Sponsor

Name	Dr Sheela Karalam B
Address	Vaidyaratnam Ayurveda Foundation Hospital Ollur, Thaikkattussery Thrissur -680306 kerala, India
Type of Sponsor	Other [Self]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Dileep K S	Vaidyaratnam Ayurveda Foundation Hospital	Speciality clinical department Room No. 2 Vaidyaratnam AyurvedaFoundation Hospital Thrissur KERALA	9961045901 dileepkshankar@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Committee for Ethics in Research	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:G431\|\|Migraine with aura. 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: MIG-T, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 650(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1.Documented history of migraine-related headaches with or without aura on fewer than 15 days per month for more than one year. 2.Participants with the MIDAS score: Grade II: Ranging from 6-10 & Grade III: Ranging from 11-20. 3. Patients with a HIT-6 score greater than 50. 4.Patients experiencing VAS score of 4–6 and PSQI score greater than 5. 5.Migraine Days Per Month (MDPM): Fewer than 15 migraine days per month. 6.Commitment to maintain a headache diary and accurately record headache frequency, duration, intensity, and associated symptoms. 7.Ability to provide written informed consent and comply with study procedures.

ExclusionCriteria

Details

1. Chronic Migraine (CM): Headache occurrence of more than 15 days per month.
2. Patient with the history of recent medication use within the past 4 Weeks such as
migraine prophylactic agents before the start of baseline observation period
2.Headaches Other Than Migraine: Presence of other primary or secondary headache
disorders.
3. The participants with known history of severe primary Psychiatric disorders
(Depression, Anxiety, Psychosis) with Generalized Anxiety Disorder (GAD) score greater than14,
major medical illness (Renal, Hepatic, Neurological and Cardiac diseases), Pregnancy,
4. Patients with known history of severe uncontrolled systemic disorders such as
Hypertension, Cardiac problems, Diabetes Mellitus, Tuberculosis, Leprosy, Paralysis,
and malignant disease.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Improvement in MIDAS, HIT, PSIQ, VAS score Changes in the monthly migraine days	Improvement in MIDAS, HIT, PSIQ, VAS score Changes in the monthly migraine days

Secondary Outcome

Outcome	TimePoints
1.Changes in severity, rescue medication use, MSQ score for quality of life 2. Safety assessments and laboratory investigations	1. Baseline, fourth week, eighth week. twelfth week 2. Baseline and twelfth week

Target Sample Size

Total Sample Size="20"
Sample Size from India="20"
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)

30/01/2026

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="3"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Background: Migraine is a neurological disorder characterized under ICHD-3 by recurrent unilateral headaches of moderate–severe intensity with nausea, vomiting, photophobia, or phonophobia, often triggered by psychological or physiological stress. Conventional prophylactic medications frequently show limited adherence, and medication overuse is common. In Ayurveda, the condition correlates with Ardhavabhedaka, a Shiroroga associated with Tridoshic imbalance and inflammatory involvement of Pitta–Rakta. Ayurvedic management focuses on doshic correction through classical therapies and internal formulations. MIG-T is a proprietary Ayurvedic polyherbal formulation developed by Vaidyaratnam, designed to support neurological stability and modulate inflammatory and stress-associated pathways. Preclinical assessments demonstrate safety compliance and suggest possible neuroprotective and anti-inflammatory

Purpose of the Study: This pilot clinical study aims to evaluate the safety, tolerability, and preliminary efficacy of MIG-T, a proprietary Ayurvedic formulation, in individuals with episodic migraine. MIG-T will be administered at a dose of 650 mg (two tablets) twice daily after food for 90 days to 20 eligible subjects. Outcomes will include improvement in MIDAS, HIT, PSIQ, VAS, monthly migraine days, migraine severity, rescue medication use, and quality of life assessed through MSQ scoring. Safety assessments and relevant laboratory investigations will be conducted throughout the study period to ensure tolerability and therapeutic safety.