Our Experiences With Natural Natural Products As Potential Therapeutic Agents : Towards Safer & Cost Effective Therapy Dr. Mrs.Chanda Kulkarni. MBBS; MD; Ph.D; FSASMS Prof. & Head, Pharmacology St. John’s Medical College INDIA HE SHALL LIVE BECAUSE OF ME

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.

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

Methods - Interventions : IERB Approval Enroll Patients Diagnosis & Clinical Examination Investigations Selection – inclusion / exclusion Informed Consent

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

Setting & Patients : Methods ANTI – DANDRUFF : Poly-Herbal Hair Oil Total Pts. N = males14 females 4 dropouts

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

18 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

Allergic Rhinitis : Methods 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 PatientSelection

Outcome Measures : Methods Before & After Treatment 1.Clinical & Patient Assessment Nasal & non-nasal symptoms – 4 occasions a] Arbitrary scale – Objectively 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.

Statistical Methods : 1.Comparison of nasal / non-nasal symptoms by students ‘t’ test. 2.Use of r escue medications in test Vs placebo group - Chi squared test. Results : 1. Overall improvement – 10/20 = < 75% 2. Clinical improvement – 14/20

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

Morphin e Atropine Digoxin Theophylline Isolation of active molecules Elucidation of structure Biological activity Lead Compounds

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

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