Health Condition 1: G508- Other disorders of trigeminal nerve
Conditions
Interventions
None listed
Sponsors
COER Medical college of Ayurveda and Hospital
Eligibility
Inclusion criteria
Inclusion criteria: Age Individuals aged between 18 and 60 years, of either gender Clinical Diagnosis of Ardhavbhedaka Patients presenting with a clinical history of recurrent headache episodes occurring fortnightly or with random frequency with at least 2 episodes per month over the last 3 months. Headache episodes must exhibit at least two of the following four characteristics Unilateral location affecting one side of the head Pulsating or throbbing quality Moderate to severe intensity Aggravation by or leading to avoidance of routine physical activity walking climbing stairs During headache episodes at least one of the following associated symptoms must be present Nausea and or vomiting Photophobia sensitivity to light and or phonophobia sensitivity to sound. General Health Condition Patients who are otherwise clinically stable and fit to undergo oral Ayurvedic therapy as determined by baseline clinical evaluation and laboratory investigations. Therapeutic Suitability Patients who are not undergoing any concurrent Panchakarma procedures or other interventions that may influence the clinical outcome of Ardhavbhedaka. Compliance and Followup Patients who are able and willing to comply with the treatment protocol dietary and lifestyle advice and scheduled followup visits on day 15 30 60 and 90 Wilingness to Participate Patients who are willing to voluntarily participate in the clinical study and have provided written informed consent after being informed about the study in a language they understand
Exclusion criteria
Exclusion criteria: Referred pain in one half of the head due to disorder of the eye, ear nose throat teeth head injury or trauma patients will be excluded. Patients suffering from diabetes tuberculosis hypertension malignancy any other general debilitating health condition needing surgical intervention. Pregnant women will be excluded. Patients on migraine causing medications like Vasodilators dopaminergic agents analgesic overdose corticosteroids SSRIs or SNRIs caffeine will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRIMARY OBJECTIVE To compare the clinical efficacy of Pathyadi Ghanavati and Shirshooladivajra Rasa in the management of Ardhavbhedaka with respect to key clinical symptoms such as: Shirashoola Tivrata (severity of headache) Shirashoola Avriti (frequency of headache) Shirashoola Avadhi (duration of headache) Hrillasa (nausea) Chardi (vomiting) Bhrama (vertigo) And overall disability assessment using MIDAS score. Timepoint: Total duration of the study-30 days. Follow-up- The patient will be examined before the commencement of treatment, on the 15thday, and 30th day during treatment. And on 60th and 90th day (after treatment-without medicine) | — |
Secondary
| Measure | Time frame |
|---|---|
| SECONDARY OBJECTIVE To evaluate the safety and tolerability of Pathyadi Ghanavati and Shirshooladivajra Rasa through observation of any adverse effects during the course of treatment. To assess the sustainability of therapeutic effect during the follow-up period at 60 and 90 days after cessation of treatment. To document and analyse patient-reported improvements in quality of life and daily functionality through structured assessments and follow-up. To explore the Ayurvedic understanding of Ardhavbhedaka and correlate it with the observed clinical response to the two trial drugs. Timepoint: Total duration of the study-30 days. Follow-up- The patient will be examined before the commencement of treatment, on the 15thday, and 30th day during treatment. And on 60th and 90th day (after treatment-without medicine) | — |
Countries
India
Contacts
Public ContactDr Nikita Nigal
APM Ayurved mahavidyalaya, Sion
Outcome results
None listed