Evaluation of Prophylactic Efficacy and Safety of Ayurvedic Intervention (Dashmool Taila and Bhunimbadi Kwatha) in Migraine Headache - NI

Dr Kumar Prabhat Bishnu0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月1日

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•Patients who will meet following criteria will be selected for the study.
•a) Adult patients (aged 18-65 years) with a diagnosis of Migraine without aura according to the International Classification of Headache Disorders 3ß (ICHD3) criteria.
•b) Patients with history of migraine type headache without aura for at least 1 year prior to the study and before the age of 50.
•c) Patients who have at least two migraine attacks per month in the last 3 months before the recruitment and not more than 15 days per month.
•d) Participants who are medically fit for nasya karma.
•e) Patients able to maintain a headache diary.
•f) Patients able and willing to provide written informed consent.
•g) No expectation that subject will be moving out of the area of the study center during the next 2 months.

•Patients who will have following characteristics not be selected for the study.
•a) Patients with a history of migraine type headache with aura.
•b) Patients with a history of hypersensitivity to any of study medications.
•c) Patients with abnormal vital signs, renal failure, hepatic disease, heart disease or any clinically significant systemic diseases.
•d) Patients with headache other than migraine, severe psychiatric disease, infections and malignancy.
•e) Patients who had taken migraine prevention drugs during the last 2 months prior to study.
•f) Patients’ headache attacks are associated with or attributable to an identifiable cause, such as: premenstrual period; a disease of eye, ear or nose; a neurological disease; or a psychiatric illness.
•g) Patients are diagnosed to have nasal pathologies that may interfere with the drug absorption.
•h) Patients who will unable to continue for the proposed length of treatment or return for follow-up visits.
•i) Serum SGOT and SGPT, Alkaline Phosphatase, Creatinine and Total bilirubin greater than the upper limits of the normal (ULN) of the reference range at the screening assessment.
•j) Patients with medication overuse and patients who had not responded to more than two different prophylactic agents.
•k) Inability to mark a visual analogue pain scale (VAS).
•l) Active participation in any type of intervention study.
•m) Patients who start developing complications.

发起方

Dr Kumar Prabhat Bishnu