Health Condition 1: G448- Other specified headache syndromes
Conditions
Interventions
None listed
Sponsors
Amrutanjan Health Care Limited, Tamil Nadu, India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex aged above 18 years. 2. Patients who can 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. Patients who had been diagnosed with primary type of headache disorders like migraine, tension type headache and other primary head ache disorders.
Exclusion criteria
Exclusion criteria: 1. Women of childbearing 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. 2. Secondary type of headache disorders. 3. Known allergy to compounds of investigational product. 4. Subjects who had a diagnosis of basilar or hemiplegic migraine. 5. Patients suffering from medical or psychiatric conditions that would increase the risk of adverse events or interfere with study assessments. 6. Participation in an investigational drug trial in the 30 days prior to the screening visit. 7. Immuno-compromised (history) individuals like known HIV positive patients or patients who are on treatment with steroids or immunomodulators. 8. Patients of vulnerable group (children, lactating mother, elderly greater than 80 years, handicapped, seriously ill, mentally challenged). 9. History of drug or alcohol abuse during the last 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the onset of pain reduction after treatment from 30 seconds up to 15 minutes continuously and then on hourly basis for 24 hours using visual analog scale To assess the duration of action ie need for second application of the test product for pain relief time frame 0-24 hours the severity of pain For statistical analysis ordinal conversion of pain levels will be assigned as 0 no pain up to 10-severe pain.Timepoint: 30 seconds up to 15 minutes continuously and then on hourly basis for 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor other complications like nausea, vomiting, photophobia, and phonophobia. To monitor for any adverse events during the study periodTimepoint: 0 to 24 hours | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
Shree Lakshmi Clinic
Outcome results
None listed