Comparison of Probiotics, Metformin and Their Combination Therapy in Improving Symptoms of Polycystic Ovarian Syndrome.̎- A Randomized Clinical Trial
Probiotic Agent
+ Metformin
Maladies génito-urinaires+10
+ Maladies Génitales
+ Maladies Annexielles
Étude thérapeutique
Résumé
Date de début de l'étude : 6 décembre 2018
Date à laquelle le premier participant a commencé l'étude.Polycystic ovary syndrome (PCOS) is a hormonal disorder affecting the women of reproductive age. It is a heterogeneous health condition that affects 1 in every 10 women of childbearing age. Women of all races and ethnicities are at risk for PCOS, but risk increases multiple folds if the BMI is greater than 30kg/m2. The common signs and symptoms, the women usually represent with are menstrual irregularities, hyperandrogenemia and multiple cysts in ovaries. The exact cause of PCOS is still unknown but genetic and obesity is considered to be the most common cause. Metformin has been considered as the first line agent for the treatment of non-insulin dependent diabetes mellitus and up till now it has been used as a first line drug for PCOS. Despite its beneficial effects in PCOS it has several adverse effects. Moreover, patients usually seek two or more drugs along with metformin to relieve maximum symptoms of PCOS like for ovulation clomiphene citrate must be given etc. So there is a need of novel and comprehensive agent that can prove to be effective in improving maximum symptoms of this disease. Probiotics have received renewed attention in the 21st century through research studies. World Health Organization's (WHO) 2001 defines probiotics as live micro-organisms that, when administered in adequate amounts, confer a health benefit on the host. In recent year it has shown tremendous promising effect in treatment of different diseases like diarrhea, gingivitis and obesity etc with negligible side effects. In this context the investigators are going to evaluate and compare the effects of probiotics, metformin and their combination therapy in treatment of various symptoms of PCOS.60 newly diagnosed PCOS patient will be assigned in the open label randomized clinical trial. As mentioned above patients will be divided into three groups with 20 patients each. In group 1, the dosage of metformin will be 500mg B.D and 2 gm of probiotic sachet O.D, the second group will be given metformin 500mg B.D. and the third group will be 2mg of probiotics B.D. It would be a follow-up study that would be conducted in Gynecology OPD of Tertiary Care Hospital
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.78 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.De 18 à 40 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: * The patient will be included according to the Rotterdam European Society for Human Reproduction and Embryology/American Society for Reproductive Medicine sponsored a PCOS consensus criterion which says the presence of any two of the following three features must be present for the patient to be diagnosed as a case of PCOS: * Oligomenorrhea and/or amenorrhea (Oligomenorrhea\>45 days or \<8 cycles per year and amenorrhea \>3 months in women with previous periodic menses) for a period of 6 months * Clinical and/or biochemical hyperandrogenemia, the presence of acne, hirsutism (FG score\>8), and alopecia * Polycystic ovaries on sonography (\>12 follicles in one or both ovaries, 2-9 mm in diameter and/or increased ovarian volume \>10 mL). Exclusion Criteria: * History of chronic diseases * Allergic to probiotic or metformin * Current or previous (within the last 6 months) use of chemotherapy or other drugs. * History of smoking * Individuals with autoimmune disease * Individuals with autoimmune disease.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.3 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
ExpérimentalGroupe III
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site