RESUMEN
Background Polycystic ovarian syndrome (PCOS) is the most common endocrine disorder in women of reproductive age, affecting reproductive, endocrine, and metabolic functions. This study was designed to validate the claims in Ayurveda regarding the efficacy of Caesalpinia crista (Latakaranj) to treat PCOS. Its seeds are uterine stimulants and ovulation inducers and improve menstrual cycle irregularities. Objectives The present study aimed to evaluate the effects of Caesalpinia crista on reproductive abnormalities, reproductive hormones, and glycemic changes in a letrozole-induced model of PCOS. Material and methods The study was performed in rats with six groups having six rats in each group. The control group was given the vehicle carboxymethylcellulose (CMC) for 21 days orally, followed by normal saline (0.9% NaCl) orally for 15 days. The inducing agent, letrozole, was given to the disease control group and the four treatment groups for 21 days, followed by a treatment period of 15 days with either clomiphene citrate (1.8 mg/kg) orally in the clomiphene group, low-dose (100 mg/kg) Caesalpinia crista, medium-dose (300 mg/kg) Caesalpinia crista, or high-dose (500 mg/kg) Caesalpinia crista. The variables assessed were daily vaginal smears to check for estrous cyclicity, body weight, blood glucose, serum testosterone (T), serum luteinizing hormone (LH), serum follicle-stimulating hormone (FSH), and the number of oocytes from each oviduct. Histopathology of ovaries was also done. Result There was no significant difference between the different groups for body weight and blood glucose. There was a significant difference between the regularity of the estrous cycle of the disease control group and the high-dose Caesalpinia crista (500 mg/kg) group (p<0.01). Hormonal levels of luteinizing hormone (LH) (p<0.05) and follicle-stimulating hormone (FSH) (p<0.05) were significantly raised in the high-dose Caesalpinia crista group, and that of testosterone was significantly decreased (p<0.05) in the high-dose Caesalpinia crista group compared to the disease control group. The number of ova was significantly high in the high-dose Caesalpinia crista group compared to the disease control group (p<0.05). Decreased number of atretic follicles was seen in the high-dose and medium-dose Caesalpinia crista group on histopathology, with an increased number of corpus lutea (p<0.05). Conclusion Treatment with Caesalpinia crista in high dose, i.e., 500 mg/kg, significantly improved the reproductive abnormalities (ovulation and menstrual irregularities) and histopathological changes associated with PCOS. It also restored reproductive hormone levels (testosterone, FSH, and LH), which are elevated in PCOS, and normalized the LH/FSH ratio, which is deranged in PCOS.
RESUMEN
BACKGROUND: The Clinical Trials Registry of India (CTRI) was launched in July 2007 and will enter its tenth year in 2017. While its mission is to encourage prospective trial registration, CTRI does permit retrospective trial registration. Against this backdrop, the present audit was carried out with the primary objective of assessing the nature and extent of trials retrospectively registered with CTRI. METHODS: All studies registered in the year 2016 were searched within CTRI using the keyword "CTRI/2016." The total number of trials registered in that year, their phase, the source of funding and their nature (Interventional or observational; whether postgraduate theses or otherwise, source of funding (pharmaceutical industry/Government of India/Institute Funded), whether prospectively or retrospectively registered were noted. We also tested for the association between the nature of the trial and retrospective registration using the Chi-square test and generated crude odds ratios with 95% confidence intervals. RESULTS: A total of 1147 studies were registered in 2016, of which 719 (63%) were retrospectively registered. Interventional studies formed the majority of studies at n = 926 (81%), while postgraduate theses constituted half of the studies (384; 53%). Postgraduate theses (relative to all other studies) were twice as likely to be retrospectively registered (cOR 2.4 [1.8, 3.0], p < 0.0001). Studies funded by the pharmaceutical industry were four times more likely to be registered prospectively relative to nonindustry funded studies (cOR 4.4 [3.2, 5.9], p < 0.0001). CONCLUSION: Given that CTRI will be insisting on prospective registration effective April 1, 2018, and as trial registration is an ethical, scientific and moral imperative, prospective registration must always be done as prerequisite to participant protection.