A Multicentric, Open label, Interventional, non-comparative study to evaluate the Efficacy and Tolerability of Volini balm for pain relief In subjects with Headache - VIN-ACHE

Sun Pharmaceutical Industries Ltd0 个研究点目标入组 65 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1. Subjects of either sex aged 18 Ã¢â?¬â?? 80 years.
•2. Subjects 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. Subjects who are diagnosed with tension-type headache as per The International Classification of Headache Disorders 3rd edition (ICHD-3) criteria.
•4. Subjects with pain score Ã¢â?°Â¥ 4/10 (based on numeric pain rating scale) during the past 1 week.

•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. Pregnant or lactating subjects
•3. Subjects diagnosed with secondary type of headache disorders and other type of primary headache disorders as per ICHD-3 criteria.
•4. Known allergy to compounds of test product.
•5. Subjects 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 during the last 30 days.
•7. Immuno-compromised (history) individuals like known HIV positive subjects or subjects who are on treatment with steroids or immunomodulators.
•8. Subjects of vulnerable group (e.g. seriously ill, mentally challenged).
•9. History of drug or alcohol abuse during the last 6 months.

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