Health Condition 1: G439- Migraine, unspecified
Conditions
Interventions
Intervention1: Unani Formulation (Ayarij): 1.Turbud sufaid Operculina turpethum L 12grams
2.Shaham e hanzal Citrullus colocynthis
(L.) Schrad.12 grams
3.Ghariqoon Polyporus officinalisb12 grams
4Saqmu
Sponsors
National Research Institute of Unani Medicine for Skin Disorders Hyderabad
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants of any gender, aged 18-60 years 2.Participants diagnosed with Shaqiqa (Migraine without Aura) as per ICHD-3 (International Classification of Headache Disorders, 3rd edition) Criteria19 3.Migraine of Grade I to III severity, based on MIDAS (Migraine Disability Assessment) Score (0-20) (Annexure IV) 4.Participants willing to sign the ICF and to comply with the protocol ICHD-3 Criteria for Migraine without Aura A. At least five attacks fulfilling criteria B-D B. Headache attacks lasting 4-72 hours (when untreated or unsuccessfully treated) C. Headache has at least two of the following four characteristics: 1. Unilateral Location 2. Pulsating Quality 3. Moderate or severe pain intensity 4. Aggravation by or causing avoidance of routine physical activity (e.g., walking or climbing stairs) D. During headache at least one of the following: 1. Nausea and/or vomiting 2. Photophobia and Phonophobia E. Not better accounted for by another ICHD-3 diagnosis.
Exclusion criteria
Exclusion criteria: 1.Patients aged below18 years or Above60 years 2.Migraine with MIDAS Grade IV 3.Patients having a Migraine with Aura 4.Non-migrainous headache: tension-type headache; cluster headache; chronic paroxysmal or non-paroxysmal hemi-cranias 5.Familial hemiplegic migraine 6.Patients with Neuropsychiatric illness 7.Use of any migraine prophylactic agents (b-blockers, anti-depressants, calcium channel blockers, anti-epileptic agents, cycle-modulating hormonal drugs, or vessel dilatation agents) within 1 month prior to screen 8.Pregnant or Lactating Women 9.Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction 10.Known cases of Immunocompromised states (HIV/ AIDS, etc.)/ Malignancies 11.Patient not willing to attend treatment schedule regularly
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in the number of headache days per month and the average duration of headache episodes (in hours), assessed using a daily headache diary, from baseline to Week 4 of treatment 2.Change in Visual Analog Scale (VAS) Score for Pain Intensity, from baseline to Week 4 3.Change in Migraine Disability Assessment (MIDAS) Score, from baseline (Day 0) to end of treatment (Week 4) Timepoint: At baseline to 1st 2nd 3rd and 4th week | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Evaluation of Safety by: a.Monitoring Adverse Events (AEs): Adverse effects related to either the Unani drug or control drug will be documented at each clinical assessment visit weekly, both as reported by the participants and observed by the physician during clinical examination. b.Changes in Laboratory Parameters (performed at baseline and at week 4): Hemogram: Hb, TLC, DLC, RBC Count, Platelet Count, ESR LFTs: S. Bilirubin, SGOT, SGPT, S. Alkaline Phosphatase KFTs: Serum Creatinine, Blood Urea Urine Examination: Routine & Microscopic ECG Change in the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) Score from baseline to the end of 4 weeks Timepoint: At baseline and 4th week | — |
Countries
India
Contacts
Public ContactDr Tahira Tabassum A R
National Research Institute of Unani Medicine for Skin Disorders
Outcome results
None listed