Recent Advances in Human Pathogenetic Trials

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Recent Advances inHuman Pathogenetic Trials

• Dr.A.B.Ram Jyothis .M.D (Hom) Pharm.
• Dept. of Homoeopathic Pharmacy,
• Fr.Muller Homoeopathic Medical College,
• Mangalore
• PHARMAKON_at_rediffmail.co
  m

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Back ground
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Back ground
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• 
  Methodological flaws in
• Hahnemannian Drug provings

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New Drug Development
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HPT vs. Phase -I trialsSimilarities

• Non- patient volunteers.
• Observation of Subjective Objective changes.
• Multiple or more specific end-points.
• Controlled experiments.
• Small number of subjects(20-100).

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HPT vs. Phase -I trialDifferences
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Sources of Current Proving Protocols

• The development of proving methods since
  Hahnemann ( Demarque,1987).
• Provings planning protocol ( Nagpaul,1987).
• The Dynamics Methodology of Homoeopathic
  Proving ( Jeemy Sherr, 1994).
• A Protocol for provings (Sankaran.S,1995).

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Current Protocol
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The Proving Team

• Project Director
• Advisor / Expert
• Proving Supervisors
• Provers

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Methodology of Proving

• 1. The Pre-proving Protocol
• 2. The Proving
• 3. Post Proving Protocol

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Criteria for Including Symptoms

• New symptoms, unfamiliar to the prover.
• Usual or current symptoms that are intensified.
• Current symptoms modified or altered.
• Old symptoms that have not occurred for at least
  one year.
• Present symptoms that have disappeared during the
  proving.
• If a symptom is in doubt, it is included in
  brackets.

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Recent Advances

• Sensitive designs
• Double blind, placebo controlled, randomized,
  four period cross - over design.
• Triple blinding.
• Revised proving time - line.
• Symptom selection criteria 9 item pathogenetic
  index.
• Rating of Symptoms Four point scale.
• Meta analysis of HPT Methodological quality
  Index.
• Concept of PPR Entanglement.

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Thank You