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1 Clinical Trial Details (PDF Generation Date :- Thu, 15 Nov :31:39 GMT) CTRI Number Last Modified On 01/10/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2012/05/ [Registered on: 07/05/2012] - Trial Registered Retrospectively No Interventional Nutraceutical Randomized, Parallel Group, Active Controlled Trial To study the effects of CollagenCal in the management of Osteoporosis in women. A RANDOMIZED, OPEN LABEL, MULTI-CENTER, TWO ARMS PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CollagenCal IN COMPARISON WITH A FORMULATION CONTAINING CALCIUM + VITAMIN D3 IN THE MANAGEMENT OF OSTEOPOROSIS IN WOMEN 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) AHC/ORT/011/10 Version No.:03 / Date : 23/05/11 U Protocol Number UTN Details of Principal Investigator Dr B Thanigai Arasu M S Ortho Orthopaedician Roshini Health Centre Phone Roshini Health Centre No 124th Street, Halls Garden, Royapettah,, INDIA roshinihealthcentre@gmail.com Details Contact Person (Scientific Query) Dr VT Sriraam MBBS MD Medical Director Phone Auroville Health Care Research and Development Private Limited Auroville Health Care Research and Development Private Limited No 180/109 Rangarajapuram Main Road Kodambakkam INDIA sriraamvt@aurovillehealthcare.com Details Contact Person (Public Query) Dr VT Sriraam MBBS MD Medical Director Auroville Health Care Research and Development Private Limited Auroville Health Care Research and Development Private Limited No 180/109 Rangarajapuram Main Road Kodambakkam INDIA 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 Phone > Nitta Gelatin Limited Type of Sponsor Auroville Healthcare R D Pvt Ltd List of Countries of Principal Investigator Dr T R Ramesh Pandian D Ortho Dr M Sundaresan D Ortho sriraamvt@aurovillehealthcare.com Source of Monetary or Material Support Primary Sponsor Details Nitta Gelatin Limited Post Box No 4262, 50/1002, SBT Avenue, Panampilly Nagar Cochin INDIA : , Tel: , Pharmaceutical industry-n No 180/109 Rangarajapuram Main Road Kodambakkam of Site Site Phone// Deepam Hospital Limited Mother Orthopedics 327 Muthurangam Road West Tambaram /134, Big Street Tiruvannamalai Kancheepuram Dr B Thanigai Arasu Roshini Health Centre No 12, 4th Street, Halls Garden, Royapettah, Dr Arvind Rajagopalan D Ortho PGDMLS Dr S Anbazhagan MS ortho Dr R Prabhakar M S Ortho S M C Ortho and Trauma Clinic 12, Violet Flats Ground Floor Vellalar Street Mogappair-West V S R Ortho Hospital Kancheepuram Kancheepuram Vyasar Bone and Joint Clinic No62, MeenambalSalai, Krishnamurthy Nagar trrpandian@gmail.com drsundaresan61@yaho o.co.in roshinihealthcentre@g mail.com arvindrajagopalan@sm cortho.com sunderrajananbazhaga n@gmail.com prabhakarortho@gmail. com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Global Ethics Approved 28/05/2011 Yes page 2 / 5

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Committee, , Tamil Nadu, Status Date Notified 06/06/2011 Health Type Patients Condition Osteoporotic changes Type Details Intervention CollagenPeptide + VitaminD3 + VitaminC + Calcium Citrate 10mg Once Daily ORAL To be taken with Water for 12 months Comparator Agent Calcium + VitaminD3 10mg ORAL TABLET to be taken with Water for 12 months Age From Age To Gender Details Year(s) Year(s) Female Inclusion Criteria Subjects whoare ambulatory women of 40 to 65 years oldwhoare willing to give informed consent Whoare willing to comply with the study procedures and restrictions are diagnosed by DEXA as osteoporotic, with BMD score of Tare diagnosed with Primary osteoporosis Exclusion Criteria Exclusion Criteria Details Subjects who are previously diagnosed with secondary osteoporosis or got presently diagnosed by clinical lab investigations. Subject who are having a BMI of more than 30 had or has fracture, as observed from medical history with in past 6 months. Subjects who had hysterectomy Subjects who had received glucocorticoids, estrogens, thyroid hormone, parathyroid hormone, fluoride, bisphosphonates, calcitonin, thiazide diuretics, barbiturates, antiepileptic medication for the past 3 months. Subjects who are suffering from systemic diseases (cardiac, hepatic, renal, hemopoietic) which the investigator feels will compromise the subjects safety. Subjects who are suffering from disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures. Pregnant, lactating women and women of child bearing potential, not practicing effective methods of contraception and planning a pregnancy during the study period. Subjects who are known to have or tested positive for human immunodeficiency virus, hepatitis C virus, or hepatitis B surface antigen Any other metabolic bone disease or secondary cause to bone loss that is not controlled and will interfere with the interpretation of the findings. Malignancy Subjects who had or has received any organ or bone marrow transplantation. Any laboratory abnormality which, in the opinion of the investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results. Subjects who are known to have calcium intolerance. Any physical or psychiatric disorder which, in the opinion of the page 3 / 5

4 Method of Generating Random Sequence Method of Concealment Blinding/Masking Stratified randomization Not Applicable Open Label investigator, will prevent the subject from completing the study or interfere with the interpretation of the study results. Alcohol or substance-abuse or smoking within the last 3 months. Subjects who recently underwent gastro-intestinal contrast studies and/or radionuclide tests before one week. Subjects who are having serum Creatinine1.3mg/dL, Serum calcium 10 mgl/dl. Subjects who are having systolic BP 175 mm Hg or diastolic BP 105mm Hg. Subjects who are in suspect of primary hyperparathyroidism with serum calcium 10mg/dL combined with PTH 5.0 mmol/l or serum calcium 9.8mg/dL combined with PTH?7.0 mmol/l. Subjects who used Ayurvedic formulation or any form of CAM (Complementary Alternative Medicine) therapy in the preceding 3 months Subjects who are currently enrolled or participated in the any other trial(s) in preceding 3 months Primary Outcome Outcome Timepoints Percentage decrease in the following markers from baseline to end of Treatment period o Serum CTx: 23-35% o Serum OC and Serum BAP : 13-20% o Free Urinary DPD : 13-20% Percentage Decrease in the following Markers from Baseline to 6months and End of Treatment o Serum CTx: 23-35% o Serum OC and Serum BAP : 13-20% o Free Urinary DPD : 13-20% Secondary Outcome Outcome Timepoints Increase in percentage of BMD from baseline to the end of treatment Period Improvement in QoL from baseline to the end of treatment Period Base Line and End of study which is after one year Target Sample Size Total Sample Size=60 Sample Size from =60 Phase of Trial Phase 3/ Phase 4 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 29/09/2011 No Date Specified Years=1 Months=6 Days=0 Not Applicable Completed NIL PROTOCOL NUMBER: AHC/ORT/011/10 STUDY TITLE: A Randomized, Open Label, Multi-center, Two Arms Parallel Group Study to Evaluate the Efficacy and Safety of CollagenCal in Comparison with a Formulation Containing page 4 / 5

5 Powered by TCPDF ( PDF of Trial Calcium + Vitamin D3 in the Management of Osteoporosis in Women. SUMMARY: The purpose of this study was to ascertain the efficacy and safety of CollagenCal in improving bone mineral density in women with osteoporosis between the ages of 40 to 65 years by evaluating percentage decrease in the bone turnover markers and improvement in BMD and overall Quality of Life (QoL) of the subjects and to compare the results with active control arm. The treatment arm received CollagenCal and the control arm received a formulation with Calcium + Vitamin D3, both to be consumed once daily for a period of one year. The analysis of the efficacy data of the subjects in the treatment arm shows that the primary objectives of percentage decreases in the Biomarkers Serum CTX, Serum OC, and Serum BAP from baseline to end of study have been met with statistical significance. However the data from udpd does not show similar results. The percentage decreases in all four biomarkers do not show statistically significant difference in the comparative analysis between CollagenCal TM and the comparator. Similarly, CollagenCal TM shows significant improvement in the Nutritional Score and Quality of Life improvement in the subject over a year but fails statistically in a comparative analysis. The bone mineral density changes as measured by DEXA Scan show that CollagenCal TM is efficacious as evident by significant change in the L1-L4 lumbar Scores (T Score, Z Score, BMD) but baseline to end of treatment. But the Total Hip Score are found to be statistically insignificant. Similarly, CollagenCal TM fails to show statistically distinguishable difference in the comparative analysis of the DEXA Scan parameters with the comparator. The same results hold true when the changes are measured from baseline to 6 months into treatment and that same midpoint to end of treatment. Thus, the analysis to assess the comparative efficacy of CollagenCal with a formulation containing Calcium + Vitamin D3 in the management of osteoporotic women and the corresponding result showed that the difference between the CollagenCal and the Comparator with respect to the change in certain efficacy parameters was not statistically significant. However, the analysis of Total Nutritional Status Scores and Total QoL Scores, including individual assessment scores of QoL showed that the CollagenCal is significantly better than the Comparator in terms of improvement in the MNA Total Score, QoL Total Score and QoL Individual Assessment Scores from baseline to end of the treatment period. page 5 / 5