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CTRI Number  CTRI/2024/07/070761 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 16/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   A Study to know the effect of siddha medicine Nelli Vadagam in the treatment of Ottrai Thalaivali (Migraine) 
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr A RAMYA 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Kancheeepuram

Kancheepuram
TAMIL NADU
600047
India 
Phone  9176208998  
Fax    
Email  aramyavkl@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr T LAKSHMIKANTHAM 
Designation  Associate Professor and Head of the Department(I/C)) 
Affiliation  National Institute of siddha 
Address  Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Kancheeepuram

Kancheepuram
TAMIL NADU
600047
India 
Phone  9025575185  
Fax    
Email  drlakshmiramaswamy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr T LAKSHMIKANTHAM 
Designation  Associate Professor and Head of the Department(I/C)) 
Affiliation  National Institute of siddha 
Address  Room no 7/8 Department of Maruthuvam National Institute of Siddha Tambaram Sanatorium Kancheeepuram

Kancheepuram
TAMIL NADU
600047
India 
Phone  9025575185  
Fax    
Email  drlakshmiramaswamy@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha, Tambaram sanatorium,Kancheepuram 600047 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  National Institute of Siddha Tambaram Sanatorium Kancheeepuram 600047 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr A Ramya  Ayothidoss pandithar hospital  National Institute of Siddha Tambaram Sanatorium Kancheepuram 600047
Kancheepuram
TAMIL NADU 		 9176208998

aramyavkl@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G439||Migraine, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nelli Vadagam  A Compound herbal drug indicated to treat Ottrai Thalaivali (Migraine) adviced to intake 6grams for 48 days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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. 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Improvement of the clinical symptoms (assessed by HIT score) from the baseline.  48 days 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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 800 has 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 admixtures affecting 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   : 530

PUBLISHED 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




 
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