CTRI Trial Data

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Clinical Trial Details (PDF Generation Date :- Fri, 01 Oct 2021 11:03:41 GMT)

CTRI Number CTRI/2013/08/003868 [Registered on: 02/08/2013] - Trial Registered Retrospectively Last Modified On 01/12/2020 Post Graduate Thesis No Type of Trial Interventional Type of Study Ayurveda Study Design Non-randomized, Multiple Arm Trial Public Title of Study Scientific Evaluation of an Ayurveda medicine in tablet form in Diabetic patients Scientific Title of A Single Centre Pilot Open Label Clinical trial to assess the Safety and Efficacy of Pramehoushadhi Study Tablets as a Monotherapy and an adjuant in patients with Type 2 Diabetes Melitus Secondary IDs if Any Secondary ID Identifier CLIN-OUSHADHI-01 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Sheela Karalam B Trial Coordinator (multi-center study) Designation Special Officer R and D Affiliation Oushadhi The Pharmaceutical Corporation (I.M) Ltd Address Oushadhi - The Pharmaceutical Corporation (I.M) Ltd Kuttanellur.P.O Thrissur Thrissur KERALA 680001 India Phone 0487-235-2109 Fax 0487-234396 Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Sheela Karalam B Query) Designation Special Officer R and D Affiliation Oushadhi The Pharmaceutical Corporation (I.M) Ltd Address Oushadhi - The Pharmaceutical Corporation (I.M) Ltd Kuttanellur.P.O Thrissur

KERALA 680001 India Phone 0487-235-2109 Fax 0487-234396 Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name DrSreejith Sreekumar Designation Chief Executive Officer Affiliation Clinfound Clinical Research Services Pvt Ltd Address 832 C1, AR3 Annexe Near Vallathol Jn. Seaport-Airport Road Thrikkakara. P. O Cochin Ernakulam KERALA 682021 India Phone 04846062400

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Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Oushadhi - The Pharmaceutical Corporation (I.M) Ltd , Kuttanellur.P.O , Thrissur,0487-235-2109 Primary Sponsor Primary Sponsor Details Name Clinfound Clinical Research Services Pvt Ltd Address 832C1, AR3 Annexe, Near Vallathol Jn. Seaport-Airport Road Thrikkakara,Cochin-682021 Type of Sponsor Contract research organization Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Sheela Karalam B Oushadhi Department of 0487-235-2109 Panchakarma Hospital Research and 0487-2334396 and Research Institute Development Room [email protected] Number 01 Shornur Road Thhrissur-680022 Thrissur KERALA Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Institutional Ethics Approved 25/05/2013 No Committee of Oushadhi Panchakarma Hospital and Research Institute,Thrissur Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Type 2 diabetes mellitus without complications Patients Type 2 diabetes mellitus without complications Intervention / Type Name Details Comparator Agent Intervention Pramehoushadhi Tablet alone 2 Pramehoushadhi tablet is a tablets twice daily before food tablet formulation of Oushadhi - for 3 months The Pharmaceutical Corporation (I.M) Ltd,Thrissur. Comparator Agent Pramehoushadhi tablet 2 tablets Pramehoushadhi tablets are twice daily bedore food given as tablet formulations of and adjuant to modern Oushadhi-Pharmaceutical pharmaceutical medicines with Corporation of India Ltd., uncontrolled sugar levels for 3 Thrissur months Inclusion Criteria Inclusion Criteria Age From 30.00 Year(s) Age To 65.00 Year(s) Gender Both Details 1.Patients between 30-65 age, both sex.
2.Body mass index

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(BMI) below 40 kg/m².
Group A
1.25 Drug naive or previously treated Type 2 DM or patients willing to shift to sole Ayurvedic treatment.
2.Hemoglobin A1c (HbA1c) ?7.5% and ?11%
3.Fasting Plasma Glucose (FPG) ?130 mg/dL
Group B.
1.25 patients with Type 2 DM with Modern Pharmaceutical Medication having insufficient glucose control.
2.Insufficient glucose control defined as laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) ?7.5% and ?11% and a Fasting Plasma Glucose (FPG) ?130 mg/dL
Exclusion Criteria Exclusion Criteria Details 1.Type 1 diabetes. 2.Current need for Insulin treatment. 3.Complication of DM. 4.Patients with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.6mg/dl), uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) or other concurrent severe disease. 5.Women who are pregnant or lactating 6.Smokers/Alcoholics and/or drug abusers 7.Patient with poorly controlled Hypertension 8.Patients with evidence of malignancy 9.Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis

Method of Generating Not Applicable Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Change from Baseline in Hemoglobin A1c Visit 1(Day 1) and Visit 12(Day 90) (HbA1c) at Week 12 (End of study). Secondary Outcome Outcome Timepoints Change from Baseline in Fasting Plasma Vist 1, Week2,Week4,Week 6, Week 8,Week Glucose (FPG) to Week 12 10,Week 12

Change from Baseline in 2-hr Post-Meal Glucose Visit 1,Week 2,Week 4,Week 6, Week 8,Week (PMG) to Week 12 10, Week 12 Symptomatic changes assessed using Ayurvedic Visit 1,Week 2,Week 4,Week 6,Week 8, Week symptom questionnaire from Baseline to week 10, Week 12 12 to assess changes in quality of life.

Body Mass Index and Blood Pressure Visit 1, Week 2,Week 4, Week 6,Week 8, Week 10, Week 12 Target Sample Size Total Sample Size=50 Sample Size from India=50 Final Enrollment numbers achieved (Total)=0 Final Enrollment numbers achieved (India)=0 Phase of Trial N/A Date of First 11/06/2013 Enrollment (India) Date of First No Date Specified Enrollment (Global)

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Estimated Duration of Years=2 Trial Months=0 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Completed Trial (India) Publication Details Study will be conducted according to Good Clinical Practices and the data will be published within 2 years of completion of the study. Brief Summary This is a clinical trial conducted to evaluate the efficacy and safety of Pramehoushadhi tablets as a stand alone medication as well as an additive to existing modern pharmaceutical medicine in patients with Type 2 Diabetes Melitus. Pramehoushadhi contains the following ingredients.Emblica officinalis, Salacia oblonga,Curcuma longa,Trigonellum foenum graceum,Phyllanthus amarus,Caessalpiniasappan,Pterocarpus marsupium, Strychnos potatorum, Ixora coccinium, Symplocos racemosus, Aerva lanata,Vetiveria zizanioides,Vernonia anthelmintica,Momordia charantia

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