A Study To Evaluate The Reproductive Toxicity And Efficacy Of VOMI-DEK Film In The Management Of Garbhini Chhardi w.s.r. To Emesis Gravidarum.

Garbhini Chhardi is common complaint during the first trimester of pregnancy. It is worldwide common obstetrical problem seen in early pregnancy in about 70%- 80% of pregnant women. Garbhini avastha is termed as delicate state. It is important to treat this condition in initial stage and prevent complications.  Slight vomiting is so common in early pregnancy (about 50%) that is considered as a symptom of pregnancy. It may occur at other times of the day. The usual onset for nausea and vomiting in pregnancy is between 4-9 weeks of gestation. NVP is common and usually begins at 6-8 weeks of gestation . Hence, there is need for an alternative, rational, safe and patent remedy. Oral thin films when placed on the tongue’s tip or floor, saliva quickly moistens the thin film, allowing for rapid hydration and subsequent disintegration to release the medication for oral mucosal absorption. The drug should dissolve easily in saliva and be highly moisture resistant. The drug should be able to permeate the oral mucosa. The quickly dissolving poly herbal oral thin films were prepared by any of the following suitable methods i.e. solvent casting method, semisolid casting method, hot melt extrusion, semi-dispersion extrusion method, roller method and drying of films. Main aim is to study the reproductive toxicity of the Vomi-DEK film and evaluate efficacy of the same in the management of garbhini chhardi w.s.r. to emesis gravidarum. The study will be carried out in such a way that firstly reproductive toxicity screening study will be done according to OECD (Organization for economic cooperation and development) guidelines 421 followed by a single blind randomized comparative clinical trial (Pilot study) will be carried out. Patients will be randomly divided into 2 groups out of which group A patients will be given trial drug and group B patients will be given standard controlled drug. Patients will be selected on the basis of inclusion and exclusion criteria. All assessment parameters and investigations will be taken into consideration.