CTRI Trial Data

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Clinical Trial Details (PDF Generation Date :- Sun, 03 Oct 2021 15:21:06 GMT)

CTRI Number CTRI/2012/05/002634 [Registered on: 09/05/2012] - Trial Registered Retrospectively Last Modified On 07/05/2012 Post Graduate Thesis No Type of Trial Interventional Type of Study Nutraceutical Study Design Randomized, Parallel Group, Multiple Arm Trial Public Title of Study comparison of parrys organic spirulina (high phycocyanin content 20-25%) with low phycocyanin spirulina (phycocyanin content10-15%)in overweight individual and to assess liver health benefit Scientific Title of Open, randomized controlled study of the efficacy of Spirulina with higher phycocyanin in obese Study people with fatty liver Secondary IDs if Any Secondary ID Identifier NIL NIL Details of Principal Details of Principal Investigator Investigator or overall Name DrKJJayakumar Trial Coordinator (multi-center study) Designation Director and Chief Medical Officer Affiliation Sir Ivan Stedeford Hospital Address Sir Ivan Stedeford Hospital MTH Road Ambattur Chennai - 600 053 Kancheepuram TAMIL NADU 600053 India Phone Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name MrSundarapandi Query) Designation Research Scientist Affiliation Parry Nutraceuticals Address Parry Nutraceuticals A Division of E.I.D.Parry (India) Ltd Dare House 4th floor No.234 N.S.C. Bose Road Chennai - 600001 India. Parry Nutraceuticals A Division of E.I.D.Parry (India) Ltd Dare House 4th floor No. 234 N.S.C. Bose Road Chennai - 600001 India Chennai TAMIL NADU 600001 India Phone Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name MrSundarapandi Designation Research Scientist Affiliation Parry Nutraceuticals Address Parry Nutraceuticals A Division of E.I.D.Parry (India) Ltd Dare House 4th floor No.234 N.S.C. Bose Road Chennai - 600001 India. Parry Nutraceuticals A Division of E.I.D.Parry (India) Ltd Dare House 4th floor No. 234 N.S.C. Bose Road Chennai - 600001 India Chennai TAMIL NADU

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600001 India Phone Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Parry Nutraceuticals A Division of E.I.D.Parry (India) Ltd Dare House 4th floor # 234 N.S.C. Bose Road Chennai - 600001 India Primary Sponsor Primary Sponsor Details Name Parry Nutraceuticals Address Parry Nutraceuticals A Division of E.I.D.Parry (India) Ltd Dare House 4th floor # 234 N.S.C. Bose Road Chennai - 600001 India Type of Sponsor Other [Nutracetical Industry] Details of Secondary Name Address Sponsor Not applicable Not applicable Countries of List of Countries Recruitment India Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr K J Jayakumar Sir Ivan Stedeford CTH Road, Ambattur, 04426580909 Hospital Near Ambattur OT Bus stop, Chennai -600053 jayakumarKJ@ammfou Sir Ivan Stedeford ndation.org Hospital MTH Road Ambattur Chennai - 600 053 Kancheepuram TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? PARRY Approved 20/02/2012 Yes INDEPENDENT ETHICS COMMITTEE Regulatory Clearance Status Date Status from DCGI Not Applicable No Date Specified Health Condition / Health Type Condition Problems Studied Patients Overweight individuals with fatty liver Intervention / Type Name Details Comparator Agent Intervention Parry Organic spirulina with 20 1g tablet morning and at night to 24% phycocyanin for 6 months Comparator Agent Spirulina with lower content of 1g tablets twice daily for 6 phycocyanin and spirulina with months higher phycocyanin content Inclusion Criteria Inclusion Criteria Age From 18.00 Year(s) Age To 65.00 Year(s) Gender Both Details Inclusion Criteria
Volunteers shall meet all of the following inclusion criteria to be eligible for participation in this study:

1.Male and female patients of age greater than 18 and less

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than 65 years shall be selected.
2.BMI greater than or equal to 25 kg/m2 or Waist circumference for male greater than 90cm & female greater than 80 cm
3.Subjects fasting blood glucose level less than 120mg/dl.
4.Subjects Blood Pressure should be between 110-139/70-89mm hg with or without treatment.
5.Triglyceride greater than 150mg/dl.
6.Ultrasound finding showing fatty liver
7.Adult patients willing to give informed consent.
8.Subject must be available for and willing to attend all evaluation visits.
9.Subject must have access to telephone for calling into the clinical center as part of test product compliance or be willing and able to fill in a daily dairy for clinical review.
Exclusion Criteria Exclusion Criteria Details Exclusion Criteria

1.Patients suffering from Diabetes mellitus 2.Subjects below the age of 18 years and above the age of 65 years 3.Subjects with BMI greater than 25 kg/m2 4.Chronic alcohol intake. 5.History of any drug abuse in the past 12 months. 6.History of hypersensitivity to study medications and related drugs or excipients in the formulation. 7.History of allergy to vegetables and or food substances and or any other manifestations suggestive of hypersensitivity reactions. 8.History of Congestive Heart Failure 9.History of End Stage Renal Failure 10.Subject with uncontrolled hypertension 11.History of stroke 12.History of myocardial infarction 13.History of Unstable angina pectoris 14.Subjects who are under treatment with Glucocorticoids oestrogens tamoxifen amiodarone methotrexate diltiazem zidovudine valproate aspirintetracycline and cocaine. 15.Patient who is not willing to participate in the study 16.Clinically significant abnormal laboratory results at screening. 17.Subject is being treated for severe active infection of any type 18.A female subject who is breast-feeding, pregnant, or intends to become pregnant during the study 19.Subject with clinically relevant uncontrolled medical condition(e.g. hematologic renal hepatic neurologic cardiac or respiratory) 20.Subject has evidence of active malignancy, or prior history of active malignancy that has not been in remission for at least 5 years 21.Participating in a clinical research trial within 30 days prior to randomization 22.Individuals who are cognitively impaired and/or who are unable to give informed consent. 23.Any other health or mental condition that in the Investigator’s opinion may adversely affect the subject’s ability to complete the study or its measures or that may pose significant risk to the subject.

The patients meeting any of the above criteria will be excluded from the study

Method of Generating Computer generated randomization Random Sequence Method of Not Applicable Concealment Blinding/Masking Not Applicable Primary Outcome Outcome Timepoints Change in metabolic reactive oxidative stress baseline 3 months 6 months

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markers 1.TNFalpha 2.Malondialdehyde 3.serum IL-6 4.Adiponectin Secondary Outcome Outcome Timepoints Efficacy of spirulina containing higher Baseline 3months 6 months phycocyanin in fatty liver volunteers Target Sample Size Total Sample Size=72 Sample Size from India=72 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 4 Date of First 24/04/2012 Enrollment (India) Date of First No Date Specified Enrollment (Global) Estimated Duration of Years=0 Trial Months=10 Days=0 Recruitment Status of Not Applicable Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details Brief Summary We intend to carry out a phase IV study of our Spirulina in Liver health in people who are overweight. This study will be a comparative clinical study with Spirulina available in market that have lower Phycocyanin content. As it is well known Phycocyanin is a useful antioxidant that gives the blue green colour to Spirulina along with chlorophyll. Parry’s Spirulina offers an appropriate content of approximately 20- 24% of Crude Phycocyanin while we see some others offering a low Phycocyanin as low as 10- 14%. The studies have revealed a number of health benefits of Spirulina ranging from high bio utility protein source to supplementary benefits in inflammation or obesity or diabetes. This clinical study will additionally show if there are benefits to Liver health especially in Non-alcoholic obese people.

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