A Pilot Clinical study to evaluate the therapeutic efficacy of the Siddha formulation of Siddhathi Ennai and Vediuppu Chunnam in Pen maladu (Female infertility)

It is a single, non randomized, open label trial to determine the efficacy and safety of Siddhathi Ennai (Prepared from herbal constitutents) and Vediuppu Chunnam (Prepared from herbo mineral constitutents) in patients with Pen maladu (Female infertility).

In this trial 10 patients will be recruited and the trial drug will be administered. Siddhathi Ennai 10ml OD dose at morning oral route 3 days duration and Vediuppu Chunnam 500mg BID dose oral route 96 days duration.

During this trail period all the study related data will be recorded and documented in a page separate trial master file for  each patients.

During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance department in NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitored by the research monitoring committee of NIS.   During this trial all the safety and efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically. The out come of this trial will be published in Indian Journal of Medical Research.