Health Condition 1: G442- Tension-type headache
Conditions
Interventions
None listed
Sponsors
Emami Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects diagnosed to have Tension Type Headache as per the ICHD 2 criteria. (having at least headache for 2 days in a month, for a duration of greater than 4 hours- if left untreated and having this for more than one year). 2. Headache without any serious medical or surgical condition requiring the continuous use of NSAID s 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, such as but not limited to disorders described i.e. untreated or uncontrolled Hyperthyroidism, Uncontrolled epilepsy, diagnosis of glaucoma, Moderate or severe persistent asthma (untreated or uncontrolled), NSAID-induced asthma diagnosed, Systemic hypertension (SH) stage 3 uncontrolled, Moderate and severe congestive heart failure, Acute myocardial infarction, unstable angina, Uncontrolled cardiac arrhythmia, uncontrolled Diabetes type 1 or type 2 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 as assessed using VAS Timepoint: Screening or Baseline Visit (Day 0), Visit 3 (Day 7), Visit 4 (Day 15) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain free period after 1 hour and 2 hours and 24 hours 2. Use of rescue medications 3. Onset and duration of Time of Cool Feeling 4. Intensity of cool feeling on VAS and gradations 5. Onset and duration of action as pain (headache) reliever of study product 6. Satisfaction of the quality of sleep 7. Change in stress using perceived stress scale 10. 8. Change in tiredness or fatigue of VAS 9. Quality of pain relief 10. Global assessment of overall change 11. Skin patch test using Dermal Response Score (BIS). 12. Global assessment of tolerability of study product 13. Assessment of adverse events including vitals Timepoint: Screening or Baseline Visit (Day 0), Visit 3 (Day 7), Visit 4 (Day 15) | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed