REF/2011/11/ CTRI Website URL -

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1 Clinical Trial Details (PDF Generation Date :- Wed, 09 May :46:52 GMT) CTRI Number Last Modified On 12/03/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/01/ [Registered on: 03/01/2012] - Trial Registered Prospectively No Interventional Homeopathy Randomized, Parallel Group, Placebo Controlled Trial To see effetiveness of homoeopathic medicines on chronic rhinosinusitis against placebo A RANDOMIZED DOUBLE BLIND PLACEBO CONTROLLED MULITCENTRIC TRIAL ON THE EFFECTS OF HOMOEOPATHIC MEDICINES ON CHRONIC RHINOSINUSITIS 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 Principal Investigator Dr Alok Kumar Director General Phone , 61-65, Institutional ccrhindia@gmail.com Details Contact Person (Scientific Query) Dr Praveen Oberai Assistant Director (H) Phone , 61-65, Institutional oberai.praveen@gmail.com Details Contact Person (Public Query) Dr Praveen Oberai Assistant Director (H) Phone , 61-65, Institutional 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 oberai.praveen@gmail.com > Type of Sponsor List of Countries of Principal Investigator Dr Subhash Kaushik Dr M N Sinha Dr Sarabjit Sarkar Dr Sunil Ramteke Source of Monetary or Material Support Primary Sponsor Details, 61-65, Institutional Research institution of Site Site Phone/Fax/ Central Research A-1/1. Sector-24, Noida.(U.P.). Gautam Buddha Nagar UTTAR PRADESH Dr. Madan Pratgap Khuteta Rajasthan Homoeopathic Medical College & Hospital, Station Road, Jaipur (Rajasthan) Jaipur RAJASTHAN Inst. (H), Rabha Bhawan, Odalbakra, Kahilipara, Guwahati Kamrup ASSAM Inst. (H), House No.2, Type-D, Lane-1, Sector-1, Below B.C.S., New Shimla, (H.P.) Shimla HIMACHAL PRADESH dr_subhash10@hotmail.com rrihjaipur@gmail.com rrihgua@gmail.com rrihshimla@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? CCRH Ethical Committee Status Not Applicable Health Type Patients Approved 07/11/2011 Yes Date No Date Specified Condition Chronic rhinosinusitis Type Details Intervention Homoeopathic medicines Acid Nit. Aconitinum Allium Cepa the indicated trial medicine shall be given to patient as per page 2 / 5

3 Inclusion Criteria Antimodicum Crude Apis Mel homoeoapthic principles, 15 ml Arsenicum Alb Arsenicum Iod once daily or as per need for 3 Aurum Metallicum Belladonna months Berbaris Vulgaris Byronia Alb Calcarea Carbonica Calcarea Hypophosphorosa Carbo Veg. Causticum Colocynthis Dulcamara Gelsemium Graphites Hepar Sulphur Ignatia Ipecacuanha Justicia Adhatoda Kalium Ars. Kalium Bich. Kalium Carb Kalium Iod Kalmia Lat Kreosote Lobelia Lilium Tigrinum Lycopodium Magnesia Carbonica Magnesium Phos Mercurius Iodatus Ruber Mercurius Sol. Natrum Carbonicum Natrum Mur Natrum Phos Natrum Sulph Nux Vomica Phosphorus Psorinum Pulsatilla Pyrogenium Rhus Tox. Sanguinaria Canadensis Sepia Silicea Spigelia Anthelmia Spongia Tosta Stannum Metallicum Staphysagria Sulphur Thuja Occ. Tuberculinum Comparator Agent Placebo the identical placebo will be given in similar to the indicated medicine, 15 ml once daily or as per need for 3 months Age From Age To Gender Details Year(s) Year(s) Both Inclusion Criteria 1.Age group between years from both gender. 2.Patients suffering from chronic rhinosinusitis (with or without nasal polyps) as defined in European Position paper on rhinosinusitis and polyps 2007.i.e. -Presence of two or more symptoms one of which should be nasal blockage/ obstruction/congestion or nasal discharge (anterior/posterior nasal drip): - facial pain/pressure - reduction or loss of smell for >12 weeks with validation by interview. 3 Written informed consent 4 Patients who can act in accordance with the protocol Exclusion Criteria Details Exclusion Criteria 1Patients who are not adequately symptomatic. 2Patients with serious underlying medical condition (eg. Severe renal or hepatic disease) 3Patients with history of malignancy. 4Patients taken any medication prior to entry into the study (can be enrolled after wash out period of 15 days). 5Patients taken topical steroids within 4 weeks before the study therapy (can be enrolled after wash out period of 1 month) 6 Atrophic rhinitis page 3 / 5

4 7Complications of chronic rhinosinusitis 8Significant psychological problems 9Pregnant women 10 Lactating mother 11Do not give informed consent. 12H/o of underlying immunodeficiencies, cystic fibrosis, bronchiectasis, chronic obstructive pulmonary disease, diabetes mellitus, neoplasia or fungal sinusitis. 13Systemic diseases preventing participation in the study and medical and/or surgical treatments influencing the study. 14 No prior paranasal sinus, nose surgery. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Pharmacy-controlled Randomization Participant and Investigator Blinded Primary Outcome Outcome Timepoints To assess the improvement in the TSS over 3 months with area under the curve. The changes from baseline to 3 months in the Sinus Nasal Outcome Test 22 (SNOT-22) To assess the improvement in the TSS over 3 months with area under the curve. The changes from baseline to 3 months in the Sinus Nasal Outcome Test 22 (SNOT-22) Secondary Outcome Outcome Timepoints Change in SNOT-22 at 6 months Objective clinical and laboratory outcome measures include changes in nasal endoscopy (at 3 months, 6 months) and CT scan (at 3 months). Changes in absolute eosinophilic count (AEC) at 3 months. No. of AE-CRS during observation period which includes endoscopic findings. Number of AE-CRS (FDI) in between groups. Changes in global assessment by patient and physician at 3 months and 6 months. 3 months, 6 months Target Sample Size Total Sample Size=120 Sample Size from =120 Phase of Trial Phase 2/ Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary 15/02/2012 No Date Specified Years=1 Months=8 Days=0 Not Applicable Open to Recruitment A Randomized Double Blind Placebo Controlled Mulitcentric Trial on the effects of Homoeopathic Medicines on Chronic Rhinosinusitis shall be conducted by Central Council for Research in Homoeopathy at its four institutes for a duration of 18 months (6 months for enrollment + 3 months treatment+ 3 months observation period+ 6 months for data analysis and manuscript preparation) page 4 / 5

5 Powered by TCPDF ( REF/2011/11/ with primary objective to evaluate the changes in total symptoms score (TSS) and the changes in Sino nasal outcome test -22 (SNOT-22). A total of 120 patients shall be enrolled (30 for each centre in the ratio Homoeoapthy:Placebo:20:10). The main Inclusion Criteria are Patients suffering from chronic rhinosinusitis (with or without nasal polyps) as defined in European Position paper on rhinosinusitis and polyps 2007.i.e. Presence of two or more symptoms one of which should be nasal blockage/ obstruction/congestion or nasal discharge (anterior/posterior nasal drip), facial pain/pressure, reduction or loss of smell for >12 weeks with validation by interview, Written informed consent, Patients who can act in accordance with the protocol, evidence of rhinosinusitis on imaging by CT Scan. One group will be given individualized homoeopathic medicines and the other group will be given placebo orally. For a period of 3 months.tss score, Sino Nasal Outcome Test-22, Lund Mackay CT scoring, Nasal Endoscopy scoring, Absolute Eosinophil Count (AEC) will be used for assessement. page 5 / 5