Effectiveness of Pankajakasthuri Migraine Oil in Reducing Migraine Headache Symptoms Among Adults: A Clinical Study

An open labeled single arm clinical trial on the Efficacy of Pankajakasthuri Migraine Oil in migraine - nil

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/11/076378

Enrollment

Registered

2024-11-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G89- Pain, not elsewhere classified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age: 18-60 years 2. Diagnosis of migraine 3. Both fresh and previously treated cases will be considered 4. Subjects of any sex 5. Migraine attacks occurring 1-6 times per month 6. History of migraine attacks for over one year

Exclusion criteria

Exclusion criteria: 1. Subjects diagnosed with other primary headache disorders 2. Referred pain due to eye, ear, nose, throat, or dental disorders 3. Systemic disorders that could interfere with treatment outcomes

Design outcomes

Primary

Measure	Time frame
Change in the severity and frequency of migraine headachesTimepoint: The severity of migraines will be assessed using a validated scale, such as the Visual Analog Scale (VAS) or the Migraine Disability ?Baseline: Prior to treatment initiation (Day 0). ?30 Days: Post-treatment, patients will report the severity and frequency of migraines. ?90 Days: Follow-up assessment to determine sustained changes. ?180 Days: Long-term assessment of treatment effectiveness.	—

Measure

Time frame

Change in the severity and frequency of migraine headachesTimepoint: The severity of migraines will be assessed using a validated scale, such as the Visual Analog Scale (VAS) or the Migraine Disability ?Baseline: Prior to treatment initiation (Day 0). ?30 Days: Post-treatment, patients will report the severity and frequency of migraines. ?90 Days: Follow-up assessment to determine sustained changes. ?180 Days: Long-term assessment of treatment effectiveness.

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Secondary

Measure	Time frame
• Changes in nausea, photophobia, phonophobia, and quality of life assessed at baseline and after six months of treatment. • Adverse effects will be monitored throughout the study period, and any reports will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE). Timepoint: Changes in Nausea, Photophobia, Phonophobia, and Quality of Life will be assessed on 30 days, 90 days, and 180 days. • Adverse effects will be tracked throughout the study period via patient-reported outcomes and clinician observations. Adverse events will be documented at each follow-up (30 days, 90 days, and 180 days).	—

Measure

Time frame

• Changes in nausea, photophobia, phonophobia, and quality of life assessed at baseline and after six months of treatment. • Adverse effects will be monitored throughout the study period, and any reports will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE). Timepoint: Changes in Nausea, Photophobia, Phonophobia, and Quality of Life will be assessed on 30 days, 90 days, and 180 days. • Adverse effects will be tracked throughout the study period via patient-reported outcomes and clinician observations. Adverse events will be documented at each follow-up (30 days, 90 days, and 180 days).

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Countries

India

Contacts

Public ContactDr Kasthuri Nair A

Pankajakasthuri Ayurveda Medical college and PG centre

aiswarya@pkhil.com9900141246

Outcome results