Health Condition 1: R51- Headache
Conditions
Interventions
Intervention1: Amrutanjan Pain Balm Extra Power: apply pea-sized amount of approximately 0.25 g of the pain balm in thin layer to the pain area,once/twice over 24 hours for 1 day.
Intervention2: Amru
Sponsors
Amrutanjan Health Care Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex aged above 18 years. 2. Patients who are able to 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 body pain disorders like knee pain, low back pain and primary type of headache disorders like migraine, tension type headache and other primary head ache disorders.
Exclusion criteria
Exclusion criteria: 1. Women of child bearing 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, known spinal disc herniation and osteoporosis. 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 >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 |
|---|---|
| The primary efficacy endpoints are: 1. To assess the onset of pain reduction after treatment at 30 seconds, 1 min, 2 min, 5 min, 10 min, 30 min and 60 min. (using visual analog scale) 2. To assess the duration of action (i.e need for second application) of the test product for pain relief. Timepoint: 30 seconds, 1 min, 2 min, 5 min, 10 min, 30 min and 60 min. | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor for any adverse events during the study period and assess the quality of lifeTimepoint: 30 seconds, 1 min, 2 min, 5 min, 10 min, 30 min and 60 min. | — |
Countries
India
Contacts
Public ContactDr Ramesh Kannan
KI3, CRO
Outcome results
None listed