Study to Find Out if the New Amrutanjan Headache Roll-On Gives fast Pain Relief in Migraine Patients

Phase 3

Not yet recruiting

• Conditions: Other migraine. Ayurveda Condition: ARDHAVABEDAKAH,

• Registration Number: CTRI/2025/06/089406
• Lead Sponsor: Amrutanjan Health Care Limited, Tamil Nadu, India

Brief Summary

This is a single-arm, open-label clinical study designed to evaluate the **safety, effectiveness, and tolerability** of the **NEW AMRUTANJAN HEADACHE FASTER RELAXATION ROLL ON** in individuals suffering from **migraine headache disorders**.

A total of **24 adult participants** diagnosed with migraine (as per international criteria) will be enrolled. The study involves the **topical application** of the roll-on to areas like the temples, behind the ears, and the back of the neck within **2 hours of headache onset**. If pain relief is not achieved within 2 hours, participants may use rescue medications (NSAIDs).

Participants will be observed over a short period of **2 days**, with follow-up assessments conducted at the clinical facility on **Day 2**. They will use the roll-on **two to three times in a day** as needed.

The **primary outcomes** include:

- Time taken to experience pain relief and complete pain relief

- Change in pain severity (using a numeric pain scale and the McGill Pain Questionnaire)

- Overall satisfaction with the product (using a 7-point Likert scale)

**Secondary outcomes** include monitoring for any **adverse events (AEs) or serious adverse events (SAEs)** within 24 hours.

This study aims to assess whether the NEW AMRUTANJAN HEADACHE FASTER RELAXATION ROLL ON offers fast and effective relief for migraine sufferers in a safe and well-tolerated manner.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-14
• Study Start: 2025-06-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• 1. Participants of either gender, aged 18 – 65 years. 2. Participants who are able to understand written and/or verbal instructions and are ready to comply with all study requirements with a willingness to participate and give written informed consent voluntarily. 3. Participants who are diagnosed with migraine-type headache (Common Migraine, Classical Migraine, Ophthalmic Migraine and Basilar Migraine) as per The International Classification of Headache Disorders 3rd edition (ICHD-3) criteria. 4. Participants with pain score greater than or equal to 3/10 (based on numeric pain rating scale) during the past 1 week. 5. Migraine attacks present for more than 1 year. 6. Migraine attacks, on average, lasting about 4.
• 72 hours if untreated. 7. 1 to 8 migraine days per month on average across the 3 months prior to the Screening Visit 8. Less than 15 headache days (migraine or non-migraine) per month in each of the 3 months prior to the screening visit and throughout the screening phase.

Exclusion Criteria

• Women of child bearing potential who are either unwilling or unable to use an acceptable method of birth control [such as oral contraceptives, other hormonal contraceptives (implants or injectable products, vaginal products, skin patches), or IUDs, barrier methods] to avoid pregnancy during the study period.
• Pregnant or lactating participants 3.
• Inability to distinguish other headaches from migraine 4.
• History of resistance to sumatriptan, or non-response to 2 or more other triptans, defined as participants who have not responded to an adequate dose and duration of treatment 5.
• Current use of medication for migraine prophylaxis that has not been stable (no dose adjustment) for 30 days prior to screening 6.
• Chronic opioid therapy (greater than 3 consecutive days in the 30 days prior to screening) 7.
• Active chronic pain syndrome (such as fibromyalgia, chronic pelvic pain, complex regional pain syndrome 8.
• Known allergy to compounds of test product.
• Participants suffering from medical or psychiatric conditions that would increase the risk of adverse events or interfere with study assessments.
• Participation in an investigational drug trial during the last 30 days.
• Immuno-compromised (history) individuals like known HIV positive participants or participants who are on treatment with steroids or immunomodulators.
• Participants of vulnerable group (e.g. seriously ill, mentally challenged).
• History of drug or alcohol abuse during the last 3 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Time to onset of relief of pain [Time frame: 0-120 minutes post dose]	30 seconds, 1 minute, 2minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes post dose
2. Time to achieve complete relief of pain [Time frame: 0-120 minutes post dose]	30 seconds, 1 minute, 2minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes post dose
3. Reduction in pain score on numeric pain rating scale (VAS) [Time frame: 30 seconds, 1 minute, 2minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes post dose]	30 seconds, 1 minute, 2minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes post dose
4. Assessment of pain relief by using McGill Pain questionnaire. [Time frame: 0-120 minutes post dose and end of 24 hours]	30 seconds, 1 minute, 2minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes post dose
5. Participants overall satisfaction for pain relief on a 7- point Likert Satisfaction scale [Time Frame: on day 2 - post dose]	30 seconds, 1 minute, 2minutes, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes, 90 minutes, 105 minutes, 120 minutes post dose

Secondary Outcome Measures

Name	Time	Method
Adverse events (AE) and serious adverse events (SAE) will be monitored	0-24 hours

Trial Locations

Locations (1)

DK Elite Health Care Center; 🇮🇳 Pondicherry, PONDICHERRY, India

DK Elite Health Care Center

🇮🇳Pondicherry, PONDICHERRY, India

Dr M Sakthi Balan

Principal investigator

9443627722

saheerose@gmail.com