Our Experiences With Natural Natural Products As Potential Therapeutic Agents : Towards Safer

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Our Experiences With Natural Natural Products
As Potential Therapeutic Agents Towards Safer
Cost Effective Therapy
BECAUSE OF ME
HE SHALL LIVE

• Dr. Mrs.Chanda Kulkarni. MBBS MD Ph.D
  FSASMSProf. Head, PharmacologySt. Johns
  Medical CollegeINDIA

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Problem Statement Natural Products NPs

• NPs Are used in routine daily life as
  dietary components as medications.
• NPs As therapeutic agents is not
• explored scientifically.
  
  
• NPs Are proposed to be cost effective
• have low toxicity profile.
• NPs May form an attractive treatment option in
  chronic illnesses.

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Objectives

• Clinical Trials In Patient Population
• To Evaluate Efficacy Safety of
  polyherbal preparations.
• To Evaluate Anti-dandruff Anti-
  allergic Rhinitis activity.

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Methods - Interventions

• IERB Approval
• Enroll Patients
• Diagnosis Clinical Examination
• Investigations
• Selection inclusion / exclusionInformed
  Consent

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Design

• Anti-Dandruff - Open Label, Prospective,
  Multicentric study.
• Anti-Allergic - Randomised, Double Blind, Placebo
  Controlled study.

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Setting Patients Methods

ANTI DANDRUFF Poly-Herbal Hair Oil
Total Pts.
N 25
11 males
14 females
4 dropouts
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Patient Selection Methods
? INCLUSION Moderate-Severe Normal-physical
/clinical ? EXCLUSION Pts. with scanty
hair Pts. with endocrine imbalance
? TREATMENT 10 ml.twice/day x 2 wks 3 visits
with follow up ? PARAMETERS Severity of
itching Degree of scalp scaling
Clinical Patient Assessment
VAS Overall / Global Improvement
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Statistics Results

• Pre post treatment scores for Itching White
  Scales compared using Paired t test

No.of Pts. Improve. 8/21 gt 75 10/21
50 75 3/21 lt 50
P lt 0.001
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Allergic Rhinitis Methods
Patient
Selection

• No.of Pts.
• N48
• Test, N24 Placebo, N24
• 12 M 12 F 14 M 10 F
• C, N 20 D, N4 C, N20
  D, N4
• PAR, N15 SAR, N5 PAR, N13 SAR, N7
• Inclusion Exclusion Criteria

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Outcome Measures Methods

• Before After Treatment
• 1. Clinical Patient Assessment
• Nasal non-nasal symptoms 4 occasions
• a Arbitrary scale Objectively 0 - 4
• b VAS Subjectively 0 to 100 mm.
• 2. Assessment of Quality of Life
• Seven disease related domains sleep, non-hay
  fever,practical problems, nasal eye symptoms,
  emotional function, overall rating.

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Statistical Methods

• 1. Comparison of nasal / non-nasal
• symptoms by students t test.
• 2. Use of rescue medications in test Vs
• placebo group - Chi squared test.

• Results
• Overall improvement 10/20 lt 75
• 2. Clinical improvement 14/20

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The POLYHERBAL Anti-Dandruff Anti-
Allergic Rhinitis formulations proved
effective Safe
Conclusions
Drawbacks

• ? Type of Formulation
• ? Multiple ingredients
• ? Method of use
• ? Duration of treatment

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Atropine
Isolation of active molecules
Theophylline
Elucidation of structure
Biological activity
Vincristine
Morphine
Lead Compounds
Digoxin
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Issues for Concern

• ? Natural Variations
• ? Manufacturing Variations
• ? Analytical methods
• ? Standardization

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Acknowledgements

• Himalaya Drug Company Pvt. Ltd.
• Natural Remedies Pvt. Ltd.
• Dr. Vaijayanthi
• Dr. Subhashchandra Shetty
• Dr. Pratibha Nadig
• Dr. V. S. Saxena,
• Dr. Bagchi