EUROPEAN JOURNAL OF
PHARMACEUTICAL AND MEDICAL RESEARCH

An International Peer Reviewed Journal for Pharmaceutical, Medical & Biological Sciences

An Official Publication of Society for Advance Healthcare Research (Reg. No. : 01/01/01/31674/16)

European Journal of Pharmaceutical and Medical Research (EJPMR) has indexed with various reputed international bodies like : Google Scholar , Indian Science Publications , InfoBase Index (In Process) , SOCOLAR, China , Research Bible, Fuchu, Tokyo. JAPAN , International Society for Research activity (ISRA) , Scientific Indexing Services (SIS) , Polish Scholarly Bibliography , Global Impact Factor (GIF) (Under Process) , Universal Impact Factor , International Scientific Indexing (ISI), UAE  , Index Copernicus , CAS (A Division of American Chemical Society) USA (Under Process) , Directory of Open Access Journal (DOAJ, Sweden, in process) , UDLedge Science Citation Index , CiteFactor , Directory Of Research Journal Indexing (DRJI) , Indian citation Index (ICI) , Journal Index (JI, Under Process) , Directory of abstract indexing for Journals (DAIJ) , Open Access Journals (Under Process) , Impact Factor Services For International Journals (IFSIJ) , Cosmos Impact Factor , Jour Informatics (Under Process) , Eurasian Scientific Journal Index (ESJI) , International Innovative Journal Impact Factor (IIJIF) , Science Library Index, Dubai, United Arab Emirates , Pubmed Database [NLM ID: 101669306] (Under Process) , IP Indexing (Under Process) , 

 ISSN 2394-3211

Impact Factor: 4.897

 ICV - 79.57

Abstract

A PLACEBO CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY & SAFETY OF INSTAVIT® SWEET DREAMS ORAL SPRAY IN THE TREATMENT OF OCCASIONAL SLEEPLESSNESS.”

*Dr. Harisha S., Director

ABSTRACT

Background: NEW Instavit® Sweet Dreams is a Melatonin based oral spray supplement that has been physician formulated. It is designed to promote a natural sleep cycle and a soothing night’s sleep with just 2 sprays. Melatonin is a natural hormone made by the pineal gland, a small gland in the brain. Melatonin helps control your sleep and wake cycles. Melatonin is sometimes called the "Dracula of hormones" - it only comes out in the dark. Objectives: The aim of the study is to evaluate the safety and efficacy of Instavit sweet Dreams oral spray in the treatment of occasional sleeplessness. Conclusion: Considering all data evaluations for Primary and secondary end-points it has been clearly determined that Instavit sweet Dreams oral spray is more efficacious than Placebo in the treatment of occasional sleeplessness. All the scales used i.e., Insomnia Severity Index, Pittsburgh Insomnia scale and Epworth sleepiness scale showed improvement in the sleeping disorders of the patients for Instavit sweet Dreams oral spray arm up to major extent in comparison to Placebo arm. No serious adverse events were observed during the clinical trial, though 6 adverse events were reported in Visit II and 7 adverse events were reported in Visit III but none of them is related with the study drug and this concludes that investigational product is safe enough to use.

Keywords: Melatonin, End of Treatment (EOT) seasonal affective disorder (SAD).


[Full Text Article]

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Google Scholar Indian Science Publications InfoBase Index (In Process) SOCOLAR, China Research Bible, Fuchu, Tokyo. JAPAN International Society for Research activity (ISRA) Scientific Indexing Services (SIS) Polish Scholarly Bibliography Global Impact Factor (GIF) (Under Process) Universal Impact Factor International Scientific Indexing (ISI), UAE Index Copernicus CAS (A Division of American Chemical Society) USA (Under Process) Directory of Open Access Journal (DOAJ, Sweden, in process) UDLedge Science Citation Index CiteFactor Directory Of Research Journal Indexing (DRJI) Indian citation Index (ICI) Journal Index (JI, Under Process) Directory of abstract indexing for Journals (DAIJ) Open Access Journals (Under Process) Impact Factor Services For International Journals (IFSIJ) Cosmos Impact Factor Jour Informatics (Under Process) Eurasian Scientific Journal Index (ESJI) International Innovative Journal Impact Factor (IIJIF) Science Library Index, Dubai, United Arab Emirates Pubmed Database [NLM ID: 101669306] (Under Process) IP Indexing (Under Process)