Clinical Evaluation of Siddha herbal formulation Nelli Vadagam in the management of Ottrai Thalaivali (Migraine) among out-patients attending Ayothidoss Pandithar hospital National Institute of siddha

BACKGROUND

Siddha system was established by great sages called 18 Siddhars.  Siddhar Theraiyar listed the disease of mankind as 4448 based on mukutram i.e.Vali, Azhal, Iyam. According to the Siddha system, diet and lifestyle play a major  role in maintaining promotion of health and in the management of diseases. The Siddha text yugi vaidhya chindhamani 800has explained Ottrai thalaivali as one of the  vatha diseases with the symptoms of Headache which is arrow piercing  in nature., lacrimation with burning sensation of eyes, stressful state of mind,tiredness and loss of appetite and tingling sensation of the body. In Siddha it comes under vatha diseases.Thus, the symptoms of ottrai thalaivali can be correlated to Migraine headache.

Migraine is a type of headache characterized by intense throbbing pain, usually on one side of the head. It can be accompanied by symptoms like sensitivity to light and sound, nausea, and vomiting. Migraines often have distinct phases, including a prodrome (pre-headache phase), aura (visual disturbances), headache, and postdrome (after-effects). Triggers can vary widely and might include stress, certain foods, hormonal changes, and more. Managing migraines involves lifestyle changes, identifying triggers, and medications. Migraine affects over one billion people worldwide and the observed one year prevalence of migraine was 63.9% in South India (the mean global prevalence is estimated at 14.7%). It is the second most common disabling condition worldwide. Migraine is a benign and recurring syndrome of headache, nausea/vomiting and/or other symptoms of neurological dysfunction in varying admixturesaffecting about 20% of females and 6% of males at some point in life. It  impacts the quality of life due to severe pain and requires long-term management.

 OBJECTIVE :To evaluate the therapeutic effectiveness of NELLI VADAGAM in the management of Ottrai thalaivali**(**Migraine) through Headache Impact Test score.

STUDY DESIGN

An open clinical study

STUDY PLACE

OPD of Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram sanatorium, Chennai-47

STUDY PERIOD

12 months

SAMPLE SIZE

30 patients

TREATMENT:INTERNAL MEDICINE: Nelli Vadagam

DOSAGE  : Kottaipakalavu – 6 gms[ twice a day, After Food,chewable]

DURATION OF TREATMENT  : 48 days

REFERENCE  : Athmarakshamrutham  ennum Vaidhiya Sarasangiragam

PAGE NUMBER   : 530PUBLISHED BY   : Sri Senbaga padhipagam

PRINTED  BY  : Surya printers, Vasanth nagar, Madhurai-03

  EDITON : 1st edition, sep 2011 

INCLUSION CRITERIA:§  Age: 18-65 Years

§  Gender: Male/Female/Transgender

§  Five migraine attacks, in the last 3 months each lasting for 4-72 hours and having any two of the following characteristics,

a)        Headache of unilateral location,

b)       Pulsating quality,

c)        Mild to moderate intensity

d)        Lacrimation with burning sensation of eyes

e)  Tiredness

Patient must have at least any one of the following symptoms,

a)        Often accompanied by nausea (and/or vomiting).

b)       Sensitivity to light and sound.

§  Headache Impact Test total score range 36-59 will be included

§  Patient who is willing to participate in the study by signing consent and fulfilling the conditions of Proforma.

EXCLUSION CRITERIA:Patients with the H/O,

§  Cervical spondylosis

§  Cerebro vascular diseases

§  Trigeminal neuralgia.

§  Traumatic history

§  Psychiatric illness

§  Seizures

§  Alcoholism

§  Pregnancy

§  Sinusitis headaches

§  Ear disorders

§   Refractive errors

§  Cluster headache

§  Patient with any other serious systemic diseases.

WITHDRAWAL CRITERIA:§  Patient turning unwilling to continue in the course of clinical trial.

§  Occurrence of any serious illness.

§  Poor patient compliance and defaulters.

·  Occurrence of any adverse reactions during the study

OUTCOME:

Improvement  of the clinical symptoms (assessed by HIT score) from the baseline.

RESULTS AND DISCUSSION

The Results will be statistically analysed and reported

KEYWORDS : Ottrai Thalaivali , Migraine, Nelli Vadagam, HIT