Health Condition 1: null- Headache
Conditions
Interventions
Intervention1: CT 64: It contains Mentha, Gaultheria fragrantissima Dosage and treatment duration: Apply sufficient quantity on the Head at the time of experiencing the episode of headache. The durati
Sponsors
Emami Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Diagnosed with Tension Type Headache as per the ICHD II criteria (History of Headache for >= 1 Year, having at least 2 days of headache in a month, and the headache lasts for >= 4 hours if untreated) 2.Subjects using Local application like oil, ointment, balm etc. the treatment of the headache. 3.Subjects not having severe Headache requiring continues medical management 4.Subjects signing written informed consent and ready to comply with the protocol requirement
Exclusion criteria
Exclusion criteria: 1.Headache due to conditions like migraine, sinusitis, cold, 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.Subjects having uncontrolled diabetes mellitus, tuberculosis, HIV, Ischemic Heart Disease 6.Subjects using oral contraceptives 7.Known other active and serious medical or surgical disease 8.Pregnancy & Lactation 9.Known hypersensitivity to compounds similar to the trial drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Percentage of subjects with total or meaningful headache relief after application of study medications 2. Assessment of pain intensity after application on Verbal rating scale (VRS) Timepoint: Day 7, Day 14, Day 21, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Assessment of effect on headache on VAS scale and pain free period after 1 and 2 hours 2. Assessment of use of rescue medications 3. Assessment of onset of action and pain relief of balm compared to ordinary balms. 4.Assessment of duration and intensity of action of the balm 5.Assessment of quality of sleep and quality of pain relief 6. Global assessment of overall effect by physician and patient 7.Assessment of absorption and spread ability of BalmTimepoint: Day 7, Day 14, Day 21, Day 28 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research
Outcome results
None listed