Clinical Trial of Three Different Topical Formulations in Headache.

Phase 2

Completed

Conditions: Health Condition 1: null- Headache

Registration Number: CTRI/2017/06/008797

Lead Sponsor: Emami Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 90

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Percentage of subjects with total or meaningful headache relief after application of study medications <br/ ><br>2. Assessment of pain intensity after application on Verbal rating scale (VRS) <br/ ><br>Timepoint: Day 7, Day 14, Day 21, Day 28

Secondary Outcome Measures

Name	Time	Method
1. Assessment of effect on headache on VAS scale and pain free period after 1 and 2 hours <br/ ><br>2. Assessment of use of rescue medications <br/ ><br>3. Assessment of onset of action and pain relief of balm compared to ordinary balms. <br/ ><br>4.Assessment of duration and intensity of action of the balm <br/ ><br>5.Assessment of quality of sleep and quality of pain relief <br/ ><br>6. Global assessment of overall effect by physician and patient <br/ ><br>7.Assessment of absorption and spread ability of BalmTimepoint: Day 7, Day 14, Day 21, Day 28