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An Unique Opportunity for
Ayurvedic Physicians to enhance
their Professional Skills
From
Dr. Sanjay Sharma
Manager – Operations & Research (Karnataka)
VCP Cancer Research Foundation (SIROs)
Evidence Based Therapeutic Ayurveda
For the first time in the history of Ayurveda, an
unique opportunity is offered for the BAMS,
MD/MS graduates to be a part of the
structured, protocol based Ayurvedic
Management and documentation of in
accordance with WHO specified GCP, GLP,
GMP guidelines
VCPCRF
“To Bring in Stated Efficacy of
Ayurveda into Mainstream Medicine”
VCPCRF (SIROs) a leading NGO, in Ayurvedic Research was founded in 1988 to
carry out in-depth and intensive research to bring the stated efficacy of Ayurveda
in main stream of medicine by using tools of modern medicine.
Vaidya Chandra Prakash Cancer Research Foundation (SIROs),is recognized as
Scientific Industrial Research Organization, by Ministry of Science and
Technology, Government of India.
It is a pioneer in developing treatment protocols for certain forms of cancer and
chronic diseases by using Ras Oushadis (herbo mineral compounds). It has
obtained US and European patent for its first invention by developing a treatment
for acute promyelocytic leukamia - a type of blood cancer.
VCPCRF - Achievements
Developed Metal Based Ayurvedic Formulation & Treatment
Protocol for the Management of Acute Promyelocytic Leukemia
Ref: Monograph CCRAS, 2006;
US of A, European and Indian Patent has been obtained
Accorded Membership of Indian Cooperative Oncology Network
Non Iron, Ayurvedic formulation for the treatment of Nutritional
Anemia
Ref: Indian Journal of Hematology and Transfusion, Medicine 2000, Vol:18,
No.4, Page 79 – 83
Developed PRAK- 20, an herbo-mineral compound, with
hepatoprotective, antifibrotic, antiinflamatory, detoxifying and anti
viral properties, proven by using various experimental and clinical
research methodology
Data on file
VCPCRF - Achievements
Developed Protocol Based Statistically Significant Clinical Data in the
Management of the following Diseases
Certain forms of Cancer Habitual Abortions
Childhood Asthma Hyperlipidemia
Chronic Bronchitis Infertility
Chronic Fatigue Syndrome IBS/Colitis
Chronic Pancreatitis Liver Diseases
Chronic Osteomylitis Migraine
Depression/Anxiety/Insomnia Multiple Sclerosis
Epistaxis Nasal Disorders
Gastritis Rheumatoid Arthritis/Gout
Peptic Ulcers Urticaria
Migraine without Aura
(Hereinafter Migraine = Migraine without Aura)
Most common disabling headache
19th amongst the debility causing diseases
worldwide as per WHO
Prevalence in India is 15 – 20% (ICMR)
Greatest Challenge to the Modern Medicine
till date
Ref: Stephen Dsilberstein, M Alan Stiles, William B Young,
Atlas of Migraine, and Other Head Aches 2nd Edition
Evidence Based Therapeutic Ayurveda
Integrated Approach in the Treatment of Migraine
Protocols developed by VCPCRF in accordance with GCP
specified by WHO and IHS
Integrated approach by way of adopting the definition of the
disease as per IHS, with defined selection criteria and Ayurvedic
treatment modalities
Strict adherence to Informed Consent, Registration and Periodic
Follow up
Outcome Based on statistical analysis and documentation
Symptoms
Migraine is one of the varieties of recurrent headaches and most common types, characterized by the following
symptoms
A Idiopathic, recurrent headache (=> 5 attacks)
B 4-72 hours duration *
C Pain characteristics (2/4)
Unilateral location
Pulsating quality
Moderate to severe intensity **
Aggravation by routine physical activity
D. During attack (1/2)
Nausea and / or Vomiting
Photophobia and phonophobia
E. At least one of the following
1. No secondary cause for headache
2. Secondary cause suggested but ruled out by investigations
3. Secondary cause present but migraine does not occur for the first time in close temporal relation to
the disorder
F. Transformed Migraine
Chronic Migraine
4 hours /day for > 15 days /month
Evolution from episodic migraine to frequent migraine
Medication overuse
*children, sleep; ** untreated or unsuccessfully treated
Symptoms Accompanying Severe Migraine Attacks
Nausea 87%
Photophobia 82%
Light headedness 72%
Scalp tenderness 65%
Vomiting 56%
Visual disturbances 36%
Paresthesia 33%
Vertigo 33%
Altered consciousness 18%
(Data Collected on 500patients by International
Headache Society)
Causes of Migraine
No Known etio-patho-physiology of migraine
Certain theories have been put forward
Genetic basis of migraine
Vascular theory of migraine
Neuronal theory of migraine
5-HT in migraine
Dopamine in migraine
Sympathetic nervous system in migraine
No Specific Laboratory Investigation for the Diagnosis of Migraine
Aggravating Factors: Sustained exertion, traveling, red wine,
cheese, chocolates, hunger, lack of sleep, menses, odors,
diarrhea
Relieving Factors: Sleep, exhilaration, Pain killers, Pregnancy
Current Treatment
The recurring attacks of migraine may be
reduced by
Stress Reduction
Elimination of certain food form diet
Regular Exercise
Temporary Relief is Obtained by
Cold Packs
Pressure on the bulging arteries
Analgesics/Migraine Specific Drugs
Current Treatment in Conventional Medicine
ß-blockers, anticonvulsants, tricyclic
antidepressent, calcium channel blocker,
riboflavin, magnesium
Selective 5-HT 1B/1D receptor agonists
Long-term administration of these drugs have
adverse effects; usage should be minimal,
and under close medical supervision.
Protocol Based Ayurvedic Treatment for Migraine
Ayurvedic treatment protocol comprising diet,
life-style and medicines
Retrospective and Prospective clinical data
from the year 1985 to 2006
Improves working efficiency
Significant reduction in paying visit to
emergency and pain killers
Saves from possible side effects & MIH
Study at VCPCRF
Preliminary Studies (1985 – 2002) by VBP
I Prospective Study
Conducted at Sri Dhanvantry Ayurvedic College & Hospital between
June 2002 & December 2004 by VBP & VPM
II Prospective Study (Ongoing)
Started on 15th May 2005, in different locations across Karnataka
Evaluated on completion of 1 year (Ref: First Annual Report) by VRB,
VHM, VSK, VHE, VSA, VSH
First Prospective Study – CHD (n= 131/104)
II Prospective Study
at various locations in Karnataka (n=267/101)
Aims and Objectives:
To prospectively study the impact of Ayurvedic
treatment in the prevention of common
migraine attacks, and its impact on migraine
frequency, intensity and associated symptoms
using Migraine disability assessment scale
[MIDAS] and visual analogue scale [VAS].
Material and Methods
From 15 May 2005 to 31 March 2006 a total
of 267 patients were enrolled in 7 Ayurvedic
clinics in the state of Karnataka** ( 3 each in
Bangalore & Bellary and 1 in Tumkur district)
under using centralized Postcard registry
system under VCPC Research Foundation
(SIROs), Dehradun, Uttranchal, India.
Inclusion and Exclusion Criteria
The selection criteria included patients with
normal blood bio-chemistry and
hematological parameters.
All patients’ fulfilled International Headache
Society [IHS] 1998 criteria for Migraine.
Patients with deranged hematological
blood biochemistry were excluded from the
study. The patients characteristics are as
shown
Treatment Protocol
The given treatment was derived following Ayurvedic concept
of diagnosing of Shiroruja
All medications were prepared at Bharat Bhaishajaya Shala
Private Ltd, Dehradun and given to all the patients in daily
dosages (table 2) for a period of at least 10 days to a maximum
period of more than 180 days (table3).
Lifestyle changes like three meals three snacks providing
adequate calories and meals devoid of nicotine, caffeine,
reheated food, aerated drugs and minimum of eight hours of
sleep were recommended.
Response Evaluation
All Patients were evaluated for Intention to
treat analysis and severity of pain and
frequency of migraine attacks on day 0,
30, 60 and 90 of treatment.
However, MIDAS score was done for
patients who have completed treatment for
at least 90 days
II Prospective Study - Karnataka
(n= 267/101)
142 History of Migraine
Distribution;
25 23
20
Number
15 13
57 12 12
10
27 5
22 5
12 2
1
2
1 2 4 0
0 0
<1 1-5 5-10 10-15 15-20 20-25 25-30 30-35 35-40 40-45 45-50
<11 11<18 18<45 >45
Duration (years)
Male Female
Frequency of Attacks Day – 0
Occ, 13
2m/1, 3 C, 55
m/1, 15
m/2, 43
w/4, 46
m/3, 8
0 Day w/3, 4
w/2, 13
w/1, 67
n=267
Impact of AyT on MIDAS
(Migraine Disability Assessment Scale)
Duration Mean Midas p Value Day 0 Day 90
in Days Score
Gr I 0 24
Gr II 2 24
Gr III 9 19
Basal 60.5 40.6 - Gr IV 90 34
90 19.22 18.41 2.67 x 10-5 Mean 60.45 19.20
Day 0
60.45 60.45
Impact = 62.2% Reduction
Day 90 19.21 19.21
0 20 40 60 80
M ean M idas Score
Mean MIDAS Score
Impact of AyT on VAS (Visual Analog Scale)
Day Day Day
Day 0 30 60 90 Duration Mean p Value
VAS Score
Mild 0 12 43 80 0 Day
9.00 ± 1.42 -
Moderate 9 48 43 18 30 days
6.11 ± 2.21 0.00086
Severe 23 30 14 3 -4
60 days 0.00321 x 10
4.05 ± 2.23
Very
-8
Severe 69 11 1 0 90 days 1.41 ± 2.32 0.00119 x 10
Reduction in Mean Pain Score
(n=101) (p<0.05)
10
9 9.01
8
7
6 6
Mean Pain
5
Score
4 3.9
3
2 2.3
1
0
Day 0 Day 30 Day 60 Day 90
Impact on Associated Symptoms
260 Nausea Photophobia Phonophobia
240
Vomiting
220
200
180
No. of Patients
160
140 Fatigue
120 Blurred
100 Vision Sweats
Abdominal
80
Pain
60
40
20
0
0 Day 30 Days 60 Days 90 Days
Impact of AyT on Associated Symptoms
Symptom Day 0 Day 30 Day 60 Day 90
Nausea No of Patients (%) 93 (92.1) 50 (49.5) 17(16.8) 06(05.9)
p Value *2.86 x 10-11 *6.79 x 10-27 *1.78 x 10-34
Vomiting No of Patients (%) 84 (83.2) 44 (43.6) 17 (16.8) 09 (08.9)
p Value *5.17 x 10-9 *4.17 x 10-21 *3.41 x 10-26
Photophobia No of Patients (%) 89 (88.1) 50 (49.5) 15 (14.8) 07 (06.9)
p Value *3.15 x 10-9 *2.05 x 10-25 *7.11 x 10-31
Phonophobia No of Patients (%) 88 (87.1) 45 (44.6) 12 (11.9) 05 (04.9)
p Value *1.77 x 10-10 *1.07 x 10-26 *1.04 x 10-31
Blurred Vision No of Patients (%) 29 (28.7) 11(10.9) 03 (03.0) 01(01.0)
p Value *0.00023 *1.19 x 10-8 *1.19 x 10-8
Fatigue No of Patients (%) 46 (45.5) 24 (23.8) 08 (07.9) 02 (02.0)
p Value *0.0014 *1.53 x 10-9 *3.50 x 10-13
Abdominal No of Patients (%) 29 (28.7) 07 (06.9) 02 (02.0) 0 (0)
pain p Value *5.24 x 10-7 *1.36 x 10-7 *5.92 x 10-9
VCPCRF Criteria for Assessment
Conclusion
Ayurvedic Treatment for Migraine without
aura, has been highly significant
statistically and clinically, in prevention of
Migraine attacks
Scientific Accreditation in International
Community
Poster Presented
and discussed at
16th Migraine Trust
International
Symposium,
18 - 20 September 2006
The Conference Centre,
Kensington Town Hall,
London, UK
What are we looking for?
Your Partnership in promotion of Evidence
Based Therapeutic Ayurveda (EBTA), in the
treatment of Migraine as a team member of
VCPCRF
Your association in having Ayurveda as the
Mainstream Medicine acceptable world wide
Your Benefits
Personalized Training and Certification
Membership in the body of EBTA practioners
Social & Professional Recognition
Exposure to International Research
Community
Opportunity to expand in specialized treatment
in various other treatments in future
Financial Gains
Our Strengths
Training
Protocol
Product
We Provide
Training & Certification in EBAT – Integrated Approach
for Migraine Treatment
All required materials including CRF’s, Manuals,
Medicines
Ongoing Support over email and phone on Patient
Care & Documentation
CME’s
Next Step
Enroll for the Training & Certification
Enhance your skills & be a specialist
Adopt Protocol Based Treatment for Migraine
for your existing and new patients
Organize and Participate in the events for
creating awareness amongst the masses
about Ayurvedic Treatment for Migraine
Participate in CME’s and Other Events
thank you
Looking forward for a
mutually beneficial
association
Dr. Sanjay Sharma
Manager – Operations & Research
VCPCRF (SIRO’s), Dehradoon
