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1 Clinical Trial Details (PDF Generation Date :- Fri, 08 Mar :58:14 GMT) CTRI Number Last Modified On 26/12/2012 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/08/ [Registered on: 17/08/2011] - Trial Registered Retrospectively No Interventional Ayurveda Dentistry Single Arm Trial To Evaluate the efficacy and safety of Himalaya Organique Toothpaste for its antiplaque activity on subjects with skin type I and II having plaque. To Evaluate the efficacy and safety of Himalaya Organique Toothpaste for its antiplaque activity on subjects with skin type I and II having plaque. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) Details of Dr. Mukta Sachdev Clinic Details Contact Person (Scientific Query) Dr. Mukta Sachdev Clinic Details Contact Person (Public Query) Rajiv Gandhi university of health sciences, Karnataka page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria > Type of Sponsor List of Countries of Principal Investigator Dr Mridu Ashok Kaushal Source of Monetary or Material Support Primary Sponsor Details Himalaya Drug Company Makali, , Pharmaceutical industry-n of Site Site Phone/Fax/ Dr. Mukta Sachdev Clinic Consultant Dentist Dr. Mukta Sachdev Clinic, 36/1, 7th Cross,1st Main, Cambridge Layout, of Committee Approval Status Date of Approval Is Independent Ethics Committee? IEC Aditya Approved 28/07/2011 Yes Status Health Type Healthy Human Volunteers Date No Date Specified Condition Subjects with Dental plaque and of skin type I and II Have a minimum of 16 natural uncrowned teeth (excluding 3rd molars) present Be in good general health. Type Details Intervention Himalaya Herbal Tooth Paste. (Neem and Pomegranate Tooth Paste) Comparator Agent NA NA Age From Age To Gender Year(s) Year(s) Both Inclusion Criteria Each enrolled volunteer will be brushing twice a day with IP (paste) for 28 days. Details Must give written informed consent and abide by the protocol sincerely and regularly visit the site for follow up Subjects aged between years, and of skin type I and II Male and Female subjects with dental plaque. Wash out period: No other medicated toothpaste/mouthwash for 1 page 2 / 5

3 week. Have a minimum of 16 natural uncrowned teeth (excluding 3rd molars) present Be in good general health. Subjects who have not participated in similar clinical study in the past four week before enrolling into the study. Exclusion Criteria Exclusion Criteria Details Subjects with preexisting systemic diseases necessitating long term medications Subjects having advanced Dentist disease Subjects having diseases of soft /hard tissues Subjects having Orthodontic appliances Subjects with Abnormal salivary function Use of oral antibiotics one (1) month prior to or during this study Pregnant or breastfeeding Participation in another clinical study in the past one month preceding this study Allergic to common dentifrice ingredients Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) Subjects who have the habit of consuming alcohol, smoking, chewing gums, pan or gutka. Subjects having orthodontic problems but not under any kind of orthodontic treatment. Subjects should not allow to use any other dental aid. Subjects not adhering to the oral hygene instructions given and not maintaining oral health. Subjects suffering halitosis due to systemic causes. Subjects having deficiency disorders like scurvy. Subjects having abnormal frenum attachment. Subjects who are mouth breathers, tongue thrusters and bruxers. Subjects having masochistic habits like tooth pick injury. Subjects using other dental aids or using hard bristle brushes. Method of Generating Random Sequence Method of Concealment Blinding/Masking Primary Outcome Outcome Timepoints Control plaque formation, fight against germs, Prevent bad breath, improve gum tightening, prevent gum bleeding and to provide complete protection to gums and teeth by visual assessment of dentist, digital photography and dental swab for plating and count of bacteria. Subject will be visiting the site day 1, day 7, day 14, day 21, day 28. The outcome will be assessed after 28 days for each subject. Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 2 Date of First Enrollment () Date of First Enrollment (Global) Total Sample Size=55 Sample Size from =55 10/08/2011 No Date Specified page 3 / 5

4 Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Years=0 Months=3 Days=0 Completed The study is an open label phase II prospective, single centric study. Study will be conducted over a period of 28 days and will include a total of 5 visits i.e. day 1, day 7, day 14, day 21, day 28. A total of 55 subjects with skin type I and II of either gender aged between years will be enrolled in the study. ICF will be obtained. The subjects who satisfy inclusion and exclusion criteria will be enrolled. A general physical examination will be performed. Volunteers will be acclimatized in a controlled temperature of 22 +/- 5 degree Centigrade and humidity of 50% +/-10% for minutes Collection of swab for plating and culture of bacteria. Investigator evaluation of the oral cavity for the presence of plaque, poor oral hygiene, bleeding gums, bad breath. Digital photograph of the oral cavity will be taken for each volunteer. Investigational product will be dispensed after weighing to each volunteer. page 4 / 5

5 Powered by TCPDF ( Method of tooth brushing with the paste will be demonstrated to each volunteer. The subject is asked to come for regular follow ups on day 7, day 14, day 21, day 28 to analyse the oral hygiene score. Any allergic or adverse reaction will be also noted on all follow up visits. Subjects self assessment will be done in all follow up visits. page 5 / 5