Clinical Study on Menthoplus Balm Headache caused due to tension

Evaluation of Efficacy and Safety of Menthoplus Balm in Subjects Suffering from Tension Type Headache - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/10/095733

Enrollment

Registered

2025-10-08

Start date

Unknown

Completion date

Unknown

Last updated

2025-10-13

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

Conditions

Health Condition 1: G442- Tension-type headache

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Subjects diagnosed to have Tension Type Headache as per the ICHD II criteria. 2. Headache without any serious medical or surgical condition requiring the continuous use of NSAIDs for pain relief. 3. Willing to comply with all requirements of the study.

Exclusion criteria

Exclusion criteria: 1. Headache due to conditions like migraine, sinusitis, headache, fever or any other underlying disease 2. History of surgery of the Head, Neck, Eyes, Ear, and Nose at least one year prior to recruitment in the study 3. Subjects who use regular analgesics for headache relief 4. Use of any other investigational drug within 1 month prior to randomization 5. Any medical conditions which may interfere with efficacy and or safety of the treatment with the investigational product 6. Known other active and serious medical or surgical disease 7. Pregnancy and Lactation 8. Known hypersensitivity to any ingredients of the trial drug. 9. Other conditions, which in the opinion of the investigators, make patient unsuitable for enrolment or could interfere with his or her participation in, and completion of the study

Design outcomes

Primary

Measure	Time frame
1. Percentage of subjects with total or meaningful headache relief 2. Change in pain (Headache) intensity Timepoint: Baseline Visit, visit 1 (Day 7), Visit 2 (Day 15)	—

Secondary

Measure	Time frame
1. Pain free period after 1 hour and 2 hours 2. Use of rescue medications 3. Onset and duration of action as pain (headache) reliever of Menthoplus Balm 4. Satisfaction of the quality of sleep 5. Quality of pain relief (ability to get back to normal) action of Menthoplus balm 6. Global assessment of overall change as assessed by physician and subjects 7. Global assessment of tolerability of study product 8. Assessment of adverse events including vitals Timepoint: Baseline Visit, visit 1 (Day 7), Visit 2 (Day 15)	—

Measure

Time frame

1. Pain free period after 1 hour and 2 hours 2. Use of rescue medications 3. Onset and duration of action as pain (headache) reliever of Menthoplus Balm 4. Satisfaction of the quality of sleep 5. Quality of pain relief (ability to get back to normal) action of Menthoplus balm 6. Global assessment of overall change as assessed by physician and subjects 7. Global assessment of tolerability of study product 8. Assessment of adverse events including vitals Timepoint: Baseline Visit, visit 1 (Day 7), Visit 2 (Day 15)

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Countries

India

Contacts

Public ContactDr Sanjay Tamoli

Target Institute of Medical Education and Research Pvt. Ltd

targetinstitute@yahoo.com9322522252

Outcome results