Positivism: An approach to develop Indian System of Medicine

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Positivism An approach to develop Indian System
of Medicine
by Vaidya Balendu Prakash B.Sc(Hons),BAMS(Ayurved
acharya)
VCP Cancer Research Foundation (Scientific
Industrial Research Organization) Mandir Marg,
Turner road, Clement town, Dehradun - 248 002 Ph
0135-2640792, 2640405, Fax [phone] E.mail
vcpcrf_at_sancharnet.in
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Present Scenario in Drug Development

• From Idea to Market
• Time span - 12 years
• Cost - 600 million dollars
• Inputs from different
• disciplines
• Regulations

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Paradox

• Resource Crunch
• Lack of Co-ordination

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Way Out

• Need Based Research
• Solutions from within
• Different System of Medicines
• Rich Experience
• Peoples Faith
• Government Patronage

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Positivism A scientific approach (19th century
Comte)
Observation Hypothesis Theory
Discovery Development of Nitrous Oxide
Penicillin
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Positivism An ISM model
Observation Preliminary study
Sorting out of patients of APML Pilot Study
1. Bone marrow aspiration peripheral blood
smear measurement 2. Liver Kidney
function test for toxicology
evaluation Hypothesis Can silver
based compound be effective for treating the
APML patients? Yes Theory 1.
Standardization of raw material 2. Development of
in-process quality control technique 3.
Standardization of finished product 4.
Toxicological studies 5. Effective Dose
studies 6. Human trials 7. Pharmacological
explanations
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Positivism An ISM model

• Controlled study to improve nutritional anemia
  by using ISM formulations.
• Non-iron Ayurvedic formulation found most
  effective in the treatment of nutritional anemia.

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Genesis of Study

• Concept and logic of treatment
• Observations
• Hypothesis
• Motivation for study

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Study Design

• Subject 600 NPG Women
• (11- 45 years)
• Group-I Control 120
• Group-II Diet IFA 120
• Group-III DietAYAS 120
• Group-IV Diet SS 120
• Group-V DietAYASSS 120
• Filter paper method used.
• 90 days study.
• QAP carried out.

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Gain in Hb (gm) among various groups
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Gain in Hb() in anemic subjects.
Moderate (7 10 gm)
Mild (10.1 12 gm)
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Gain in Hb (gm) among different age groups
(11 18 yrs)
(19 45 yrs)
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Drug Development from ISM

• Need for Reorientation
• Shedding Inhibition
• De-Schooling
• Flexibility

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Leap from Tradition to Technology

• Documentation of Clinical
• Experiences
• Pilot Studies
• Prima facie evidence for New
• Clinical Entity NCE

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Essential Requisite for Drug Development

• Reproducibility
• Safety
• Efficacy
• Availability
• Pharmacological Explanations

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On going efforts - I

• Observational research on the patients of
  different forms of cancer, specially to
• ?Acute Leukaemia,
• Lymphoma
• Multiple Myeloma
• (de novo, relapse post
  remission)
• ? Solid tumor
• (post surgery)

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On going efforts - II

• Observational research on the patients of
• Backache, Childhood-asthma, Chronic bronchitis,
  Chronic-fatigue-syndrome, Corns,
  chronic-pancreatitis, Epistaxis, Gastritis,
  Duodinitis, Colitis, Peptic-ulcer,
  Habitual-abortion, Headache (Migraine),
  Hyperlipidema, Infertility, Irritable-bowel-syndro
  me, Liver diseases (Hepatitis), Nasal-disorders,
  Obesity, Rheumatoid arthritis/Gout, Stress,
  Depression, Anxiety, Insomnia, Sub mucos oral
  fibrosis, Urticaria.

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Preliminary Findings on Patients
With Headache (01-06-02 to 31-03-04)

• Total Enrolled Patients - 114
• Medicine didnt start 16
• n 98
• Post Ay Rx
• Symptom Mild No change
  Lost to
• Free Occasional
  follow up
• 35 20 32
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• Success rate 56
• 10 patients on treatment

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Preliminary Findings on Patients
With Childhood asthama (01-06-02 to 31-03-04)

• Total Enrolled Patients - 23
• Medicine didnt start 4
• n 19
• Post Ay Rx
• Symptom Mild Lost to
  
• Free Occasional
  follow up
• 14 1 4
• Success rate 73.6
• 6 patients on treatment

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Project in action

• Phase-II study on APML Patients by ICON using Ay.
  treatment protocol
• Clinical study on sustainable effect of Non Iron
  Ayurvedic treatment for anemia
• Standardization of three anti cancer ayurvedic
  preprations
• PADAAV - Speciality Ayurvedic Treatment Centre
  through proficient BAMS

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PARTNERS

• Government
• Industry
• Institution
• Academics
• Professionals
• Community

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Thank you