Clinical Trial Details (PDF Generation Date :- Wed, 22 Aug 2018 08:47:30 GMT) CTRI Number CTRI/2009/091/000605 [Registered on: 18/01/2011] - Last Modified On 15/02/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Ayurveda Randomized, Parallel Group, Placebo Controlled Trial A Clinical Study to evaluate the Efficacy and Safety of TLPL/AY/04/2008 as an adjuvant to Oral Hypoglycemic agents (OHAs) in Type 2 Diabetic Patients. A Randomized, Double blind, Placebo controlled, Phase 2 Clinical Study to evaluate the Efficacy and Safety of TLPL/AY/04/2008 as an Add-on therapy with Oral Hypoglycemic agents (OHA) in Type 2 Diabetic Patients. 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) TLPL/AY/04/2008/CT-1, Version 2, Dated 24.07.2009 Protocol Number Details of Principal Investigator Address 153 Magarpatta City Road Hadapsar 153 Magarpatta City Road Hadapsar Details Contact Person (Scientific Query) Address 153 Magarpatta City Road Hadapsar 153, Magarpatta City Road, Hadapsar Details Contact Person (Public Query) Address 153 Magarpatta City Road Hadapsar 153, Magarpatta City Road, Hadapsar page 1 / 5
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 Source of Monetary or Material Support > Tulip Lab Private Limited F-20/21 MIDC Ranjangaon Taluka Shirur Dist Pin 412220 Address Type of Sponsor NIL List of Countries of Principal Investigator Dr Deelip Mane Primary Sponsor Details Tulip Lab Pvt Ltd F-20/21 MIDC Ranjangaon Taluka Shirur Dist. Maharashtra State Pin-412220 Pharmaceutical industry-n Address NIL of Site Site Address Phone// Department of Medicine, OPD No. 8, Ground Floor 153 Magarpatta City Road Hadapsar 09922442350 dileep.mane@yahoo.co.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? Institutional Ethics Committee, Noble Hospital, Hadapsar, Status Not Applicable Health Type Patients Approved 29/07/2009 No Date No Date Specified Condition Type II Diabetes mellitus Type Details Intervention TLPL/AY/04/2008 Each Film coated tablet contains Madhunashini extract (Gymnema sylvestre R.Br), Asana extract (Pterocarpus marcupium Roxb.), Amalaki extract (Emblica officinalis Gaertn), Mamijva extract (Enicostemma littorale Blume) and Jambu extract (Syzygium cumminii Linn) Dosage and Treatment Duration: Two tablets twice daily orally before meals as add on therapy to oral hypoglycemic agent(s)for three months Comparator Agent Placebo Tablets Each film coated tablet contains microcrystalline cellulose, Croscarmellose sodium, Crospovidone, Methyl paraben, page 2 / 5
Inclusion Criteria Age From Age To Gender Details 20.00 Year(s) 70.00 Year(s) Both Inclusion Criteria Propyl paraben, Colloidal anhydrous silica, Magnesium stearate, Hydroxypropyl methylcellulose, Polyethylene glycol, Talc, Titanium dioxide, Iron oxide red, Iron oxide yellow and Purified water. Dosage and Duration of Treatment: Two tablets twice daily orally before meals as an add on therapy to oral hypoglycemic agent(s) for three months 1. Subjects suffering from type 2 diabetes mellitus for more than one year, and stabilized on mono / polydrug oral anti-diabetic therapy (Sulfonylurea alone or combination of sulfonylurea and Biaguanides) for at least last 3 months. 2. Subjects having HbA1C value between 7-10% (both inclusive) at screening. 3. Subjects having Fasting Plasma Glucose 126-252 mg/dl (both inclusive) at screening. 4. Subjects of male gender or a nonpregnant, nonlactating females, at least six weeks postpartum. A urine pregnancy test is required for all female subjects unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal. 5. Subjects having a body mass index (BMI) of 20? 35 kg/m2. 6. Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form. Exclusion Criteria Details Exclusion Criteria 1. Subjects on insulin therapy or on oral hypoglycemic agents other than Sulfonylurea and Biaguanides. 2. Subjects suffering from type-1 DM or types of Diabetes mellitus other than Type -2. 3. Subjects having known hepatic or renal disease. 4. Subjects having an active malignancy. 5. Subjects giving history of significant cardiovascular event 6. Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds. 7. Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. 8. Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes. 9. Use of any other investigational drug within 1 month prior to randomization 10. Known hypersensitivity to ingredients used in study drug 11. Pregnant and Lactating females. Method of Generating Random Sequence Method of Concealment Blinding/Masking Computer generated randomization Pre-numbered or coded identical Containers Participant and Investigator Blinded page 3 / 5
Primary Outcome Outcome Timepoints To evaluate the efficacy of TLPL/AY/04/2008 in comparison with matching placebo as add-on therapy to OHA in patients suffering from type 2 Diabetes mellitus by assessing, 1.Changes in Fasting and Postprandial Plasma Glucose levels 2.Changes in HbA1C% Value Day 0, Day 30, Day 60 and Day 90 Secondary Outcome Outcome Timepoints 1.Changes in fasting Serum insulin level Day 0, Day 30, Day 60, Day 90 2.Reduction in dose of OHAs 3.Improvement in clinical symptoms of Type 2 DM 4. Global assessment for overall improvement by the subject 5. Global assessment for overall improvement by the investigator 6. Tolerability of study drugs assessment by study subject and investigator 7. Laboratory parameters like Liver function tests (LFT), renal function tests (RFT), Lipid Profile, Complete blood count (CBC), ESR, Hb% and Urine Examination Target Sample Size Total Sample Size=80 Sample Size from =80 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 26/12/2009 No Date Specified Years=1 Months=6 Days=0 Not Applicable Completed None Yet Patients of Type-2 DM attending outpatient clinic at will be screened for eligibility criteria. On screening visit, a written informed consent will be obtained from subjects for their participation in the study. Subject s history will be recorded and his/her physical examinations will be done. Then patient will undergo investigations (viz. CBC, ESR, Hb%, BSL Fasting and PP,Urine Sugar (Fasting & PP) Serum insulin, HbA1C, Liver function tests, Renal function tests, Lipid profile, Urine routine and microscopic examinations, Urine pregnancy test (only if the subject is female of child bearing potential), Stool routine & microscopic examinations, HIV test, X- ray chest (PA View) and ECG). Diary card to record daily symptoms of diabetes will be provided to patients. A wash out period of 7 days will be advised during which patients will have to refrain from anti-diabetic medicines (Herbal /homeopathic etc) other than OHA prescribed by Investigator. On baseline visit, subject will be recruited in the study if he/she meets all the inclusion criteria. Subjects will then be randomized to one of the two study groups as per the computer generated randomization list. Subjects will undergo general and systemic examinations. At baseline visit and on every follow up visit (except last follow up visit), subjects will be provided with diary card to record daily symptoms of DM. On every follow up visit, filled diary card will be collected and symptoms assessed and graded on clinical symptom scoring scale as given in Appendix-C. At baseline visit and at every page 4 / 5
Powered by TCPDF (www.tcpdf.org) PDF of Trial follow up visit (except last follow up visit), as per computer generated randomization list, subjects will be provided a HDPE container containing 72 tablets (60 tablets for 15 days + additional 12 tablets for use if the follow up is delayed maximum by three days) of either?tlpl/ay/04/2008? or matching placebo. Subject will be advised to consume medication in a dose of 2 tablets twice daily orally before meals for next 15 days. Subject will be advised to continue his/her allopathic anti-diabetic medicines (OHAs). Drug compliance will also be assessed by the investigator on every follow up visit. Subjects will be advised to continue the diabetic diet and exercise regimen (which they are already following) during the entire study. Subjects will be called to for follow up visits on every 15th day upto 90 days after the baseline visit. On every follow up visit, they will undergo general and systemic examinations and assessment of clinical symptoms of type 2 DM will be done. Subject?s blood sugar (fasting & PP) and Urine sugar (Fasting & PP) will be checked on every month. Patient?s global evaluation for overall improvement and Investigator?s global evaluation for overall improvement will be done on completion of the study. Tolerability of the trial drugs will be assessed by the investigator and by the patient at the end of the trial. All the patients will be closely monitored for any Adverse Events starting from baseline visit till the end of the study visit. On final follow up visit (i.e. Day 90) subjects laboratory investigations (viz. CBC, ESR, Hb%, BSL (fasting & PP), Urine Sugar (Fasting & PP), Serum insulin, HbA1C, Liver function tests, Renal function tests, Lipid profile, Urine routine & microscopic, Stool routine & microscopic) will be performed. After completion of 90 days of study treatment, all the subjects will be asked to stop trial medication and take advice of investigator for further treatment. page 5 / 5