CTRI Number	Pending [Registered on: //]
Last Modified On:	11/01/2020
Post Graduate Thesis	Yes
Type of Trial	Interventional
Type of Study	Nutraceutical
Study Design	Non-randomized, Placebo Controlled Trial
Public Title of Study	Effect of Supplementation of Formulated GSMA supplement on Hypercholesteromia
Scientific Title of Study	A Randomized Single-Blind Placebo Controlled Crossover Clinical Trial To Compare The Safety And Efficacy of Formulated Nutraceutical in Hypercholesteromia
Secondary IDs if Any	Secondary ID  Registry  NIL  NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)	Name  Radhaisris S  Address  PSG College of arts and science coimbatore Coimbatore TAMIL NADU 641014 India  Phone  09842278775   Fax     Email  radhaisris@yahoo.com
Details Contact Person Scientific Query	Name  Radhaisris S  Address  PSG College of arts and science coimbatore Coimbatore TAMIL NADU 641014 India  Phone  09842278775   Fax     Email  radhaisris@yahoo.com
Details Contact Person Public Query	Name  Radhaisris S  Address  PSG College of arts and science coimbatore Coimbatore TAMIL NADU 641014 India  Phone  09842278775   Fax     Email  radhaisris@yahoo.com
Source of Monetary or Material Support	SAY nutrireach academy
Primary Sponsor	Name  SAY Nutrireach Academy  Address  vijayani nutraceuticals pvt ltd first floor, Ambattur, Chennai  Type of Sponsor  Other [research organisation]
Details of Secondary Sponsor	Name  Address  NIL  NIL
Countries of Recruitment	India
Sites of Study	No of Sites = 1   Contact Person  Name of Site  Site Address  Phone/Fax/Email  sasikala  SAY Nutrireach academy  New No. 571,old no. 327, 1st Floor, kamaraj Bhavan Poonamallee High Road Chennai   9176654371 sasiadu@yahoo.co.in
Details of Ethics Committee Modification(s)	No of Ethics Committees= 1   Name of Committee  Approval Status  Queen marys college  Submittted/Under Review
Regulatory Clearance Status from DCGI	Status  Not Applicable
Health Condition / Problems Studied	Health Type  Condition  Healthy Human Volunteers  Boardline cholesterol
Intervention / Comparator Agent	Type  Name  Details  Intervention  Grape seed extract with mangosteen extract  1000 mg/day, duration 3 months, oral  Comparator Agent  NIL  NIL  Intervention  Pacebo, no treatment  no treatment
Inclusion Criteria	Age From  35.00 Year(s) Age To  60.00 Year(s) Gender  Both  Details  Adult males or females with diagnostics of hypercholesteromia
ExclusionCriteria	Details  A history of recent or chronic use of oral hypolipidemic therapy or chronic use of insulin or any prescription medications or dietary supplements known to alter LDL cholesterol (specifically sterol and stanol products, psyllium-based fiber supplements, or red yeast rice), and women who were pregnant or breastfeeding .
Method of Generating Random Sequence	Other
Method of Concealment	Sequentially numbered, sealed, opaque envelopes
Blinding/Masking	Participant and Outcome Assessor Blinded
Primary Outcome	Outcome  TimePoints  Changes in Lipid profile  Changes in Lipid profile, 12 weeks
Secondary Outcome	Outcome  TimePoints  Changes in weight  Changes in weight, 12 weeks
Target Sample Size	Total Sample Size="160" Sample Size from India="160"
Phase of Trial	Post Marketing Surveillance
Date of First Enrollment (India)	12/04/2018
Date of First Enrollment (Global)	No Date Specified
Estimated Duration of Trial	Years="0" Months="3" Days="0"
Recruitment Status of Trial (Global) Modification(s)	Not Applicable
Recruitment Status of Trial (India)	Completed
Publication Details	No
Brief Summary	This study is a single blind, parallel group, interconventional trial comparing the safety and efficacy of formulated grape seed and mangosteen rind extract in capsule form with 1000 mg daily for 3 months in 500 patients with hypercholesteromics subjects was conducted in india.