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HE SHALL LIVE

This study explores the use of natural products as potential therapeutic agents to provide safer and cost-effective treatments for chronic illnesses. Clinical trials evaluate the efficacy and safety of polyherbal preparations for conditions like dandruff and allergic rhinitis. Various methods and interventions are used, and outcomes show promising results. The study discusses drawbacks, issues, and areas for improvement in utilizing natural products in healthcare.

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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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