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HE SHALL LIVE

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; FSASMS Prof. & Head, Pharmacology St. John’s Medical College INDIA.

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HE SHALL LIVE

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  1. 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. John’s Medical CollegeINDIA

  2. 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 proposedto be cost effective & havelow toxicityprofile. NPs : May form an attractive treatment option in chronic illnesses.

  3. Objectives : Clinical Trials In Patient Population – To Evaluate : Efficacy & Safety of polyherbal preparations. To Evaluate : Anti-dandruff & Anti- allergic Rhinitis activity.

  4. Methods - Interventions: • IERB Approval • Enroll Patients • Diagnosis & Clinical Examination • Investigations • Selection – inclusion / exclusionInformed Consent

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

  6. Setting & Patients : Methods ANTI – DANDRUFF : Poly-Herbal Hair Oil Total Pts. N = 25 11 males 14 females 4 dropouts

  7. 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

  8. Statistics & Results Pre & post treatment scores for Itching & White Scales compared using Paired ‘t’ test No.of Pts. Improve. 8/21 > 75% 10/21 50% – 75% 3/21 < 50% P < 0.001

  9. Allergic Rhinitis : Methods Patient Selection No.of Pts. N=48 Test, N=24 Placebo, N=24 12 M + 12 F 14 M + 10 F C, N =20 D, N=4 C, N=20 D, N=4 PAR, N=15 SAR, N=5 PAR, N=13 SAR, N=7 Inclusion & Exclusion Criteria

  10. 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.

  11. 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 = < 75% • 2. Clinical improvement – 14/20

  12.  Type of Formulation  Multiple ingredients  Method of use  Duration of treatment The POLYHERBAL Anti-Dandruff & Anti- Allergic Rhinitis formulations proved effective & Safe Conclusions : Drawbacks :

  13. Isolation of active molecules Atropine Theophylline Elucidation of structure Biological activity Vincristine Morphine Lead Compounds Digoxin

  14. Issues for Concern :  Natural Variations  Manufacturing Variations Analytical methods Standardization

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

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