Reviews on Recent Clinical Trials - Volume 20, Issue 1, 2025

Microbial imbalance is thought to play a role in the pathogenesis of Diverticular Disease (DD).

We aimed to assess the efficacy of a symbiotic mixture (Prolactis GG Plus^®) in the treatment of moderate to severe DD, scored according to the Diverticular Inflammation and Complication Assessment (DICA) classification.

A retrospective study was conducted enrolling the following patients: at the first diagnosis of DD; in whom DD was diagnosed with colonoscopy and scored according to DICA classification; treated with Prolactis GG Plus^® two times/daily for 2 consecutive months; in whom the severity of the abdominal pain was scored with a 10-points visual-analogue scale (VAS) at baseline and the end of follow-up; in whom fecal calprotectin (FC) was assessed at baseline and the end of follow-up as µg/g.

Twenty-four patients were identified (10 males, 14 females; 16 as DICA 2, and 8 as DICA 3). Prolactis GG Plus^® decreased the severity of abdominal pain both in DICA 2 (p =0.02) and DICA 3 patients (p =0.01), while FC decreased significantly in DICA 2 (p <0.02) but not in DICA 3 (p =0.123) patients. Acute diverticulitis occurred during the follow-up in two DICA 3 patients but none DICA 2 patients. Add-on therapy was required by eight DICA 2 (50%) and six DICA 3 patients (75%).

In newly diagnosed patients with DD, the symbiotic mixture Prolactis GG Plus^® can be a potential treatment for moderate (DICA 2) DD as a single treatment.

The aim of this study was to assess the role of seminal Malondialdehyde Acid (MDA) in the diagnosis of male infertility.

Both male and female infertility is increasing all over the world.

The purpose of this study was to assess the impact of seminal MDA levels on various semen parameters of healthy fertile men and men with infertility, and to know the efficacy of seminal MDA in the diagnosis of male infertility.

This case-control study was carried out at the Department of Obstetrics and Gynaecology of a tertiary care center in rural Southern India over a period of two years. The study included 90 infertile men (≥21-50 years) having some pathology in semen reports as cases and 90 fertile men (having biological children) with normal semen reports as controls. Biochemical tests for MDA were performed using Human MDA Assay kits on 180 cryopreserved semen samples following the standard protocol. Results of seminal MDA levels were assessed among cases and controls and correlated with different semen parameters.

The mean±SD age for cases was 30.10 ± 4.75 years, and for controls, it was 29.79 ± 5.08 years. Of all the cases, 44 (48.9%) had asthenozoospermia, 22 (24.4%) had oligoasthenozoospermia, 14(15.6%) had oligozoospermia, and 10 (11.1%) had azoospermia. A statistically substantial variance was observed in mean values of MDA (1.03 ± 0.31 mmol/mL vs. 0.60 ± 0.14 mmol/mL; p =0.001) between fertile men and men with abnormal semen reports. A negative association was observed between semen MDA levels with sperm motility, concentration, and normal morphology in 180 participants. The sensitivity of MDA for male infertility prediction was 86.67% at 76.67% specificity, 78.79% positive predictive value, and 78.79% negative predictive value.

MDA has been found to be a promising biomarker for predicting male infertility. However, large sample sizes and prospective cohort studies are required to further confirm its predictive accuracy across various populations.

The objective of this Multicentric Post-Marketing Surveillance (PMS) study was to evaluate the safety and tolerance of vitamin C and zinc tablets in the Indian population experiencing deficiencies of these nutrients. Furthermore, the study aimed to provide insights into physicians' prescription practices and characterise the patient population receiving the study medication.

This prospective observational study involved 358 participants from 8 study sites across India (including 2 government hospital sites), spanning a duration of approximately 12 weeks (3 months). The primary aim was to evaluate the safety and tolerability of zinc and ascorbic acid effervescent tablets for those who were deficient in zinc and vitamin C. Throughout the study period, adverse events were monitored and categorised by MedDRA Primary System Organ Class and Preferred Term. The analysis included evaluating the incidence, percentage, and correlation of adverse events with the treatment (safety population). Additionally, the frequencies of adverse drug reactions were examined across all enrolled patients. Vital signs and symptom-focused physical examinations were conducted during each visit in the safety population.

Out of 358 (100%) patients, only 12 (3.35%) experienced minor symptoms in the study period. The majority of patients reported gastrointestinal disorders, i.e., two (0.6%) patients reported constipation and gastritis, respectively. Diarrhoea was reported by four (1.1%) patients. One (0.3%) patient reported gastrointestinal pain. Three (0.8%) patients reported vomiting. Diarrhoea was the most common symptom reported. All patients possess a mild intensity of adverse drug reactions in safety populations. The p-value is less than 0.05 (p-value < 0.05), and therefore there is a statistically significant relationship between the predictor variables and the response variable (i.e., the expected count of adverse drug reactions).

The fixed-dose combination of vitamin C and zinc effervescent tablets appears to be safe and tolerable for the treatment of vitamin C and zinc deficiencies in Indian patients. The favorable outcome underscores the mild nature of the adverse reactions and the right medical interventions and support.

Maternal position during delivery can affect the physiology of labour and the mechanics of childbirth.

The study aimed to evaluate the impact of an upright position during the first stage of labour on maternal outcomes.

This parallel group randomised control trial was conducted from April to June 2020 among 60 women (30 each in the experimental and control groups) admitted to the selected hospital in Punjab, India. Women who entered the active stage of labour naturally with a single live foetus in cephalic presentation, aged 18-45 years, and with normal body mass index were randomly assigned either to the experimental or control group using a concealed envelope method. Women in the experimental group were informed and encouraged to adopt the upright position, while those in the control group received the standard routine care during the first stage of labour. The effectiveness of upright positions during the first stage of labour was assessed in terms of duration of the first, second, and third stages of labour, mode of delivery, and perineal lacerations. Outcome assessors were blinded to the intervention. The differences in the groups were evaluated by mean, median, frequency, percentage, Chi-square, and t-test.

The results of 60 women were analysed. Women in the experimental group experienced a significant reduction in the incidence of instrumental delivery (p =0.005), perineal laceration (p =0.001), and duration of the first stage (p =0.0001) and third stage (p =0.0001) of labour compared to those in the control group. No harm was reported across the study groups.

This study urges nurses and midwives to recommend the use of upright positions during the first stage of labour to reduce the duration of labour and incidence of perineal laceration among women.

CTRI/2022/04/041740.

It has been proposed that colchicine may have the potential to prevent cardiovascular and cerebrovascular dysfunctions.

This study evaluated the impact of colchicine on preventing recurrent stroke in patients with both ischemic stroke (IS) and atrial fibrillation (AF).

A randomized, double-blinded, placebo-controlled trial was conducted at Golestan Hospital (Ahvaz, Iran) over one year, involving IS patients with AF. Demographic and clinical data were collected from the participants, who were then assigned to either the intervention or placebo groups. The experimental group was administered colchicine at a dosage of 0.05 mg twice daily for one year, while the control group received a placebo at a comparable dosage over the same timeframe.

In one year, 108 patients completed the study. There were 55 patients in the intervention group and 53 patients in the placebo group. During the second trimester of the trial, three patients in the colchicine group and 10 patients in the placebo group experienced recurrent strokes. Gastrointestinal issues were the most commonly reported complications (33 cases) among the two groups, followed by myalgia (8 patients). There were significant differences in the frequency of recurrent stroke and serum levels of C-reactive protein (CRP) between the colchicine and placebo groups (p < 0.05) after intervention.

In this study, colchicine was effective in reducing recurrent stroke and CRP levels in IS patients with AF compared to the control group. Further randomized controlled trials with larger sample sizes and extended durations are recommended to validate the results of this trial.

IRCT20130311012781N5.

Postpartum hemorrhage (PPH) is one of the three leading causes of maternal mortality. Herbal medicine is one of the well-known methods of treatment in the world.

This study was conducted to determine and compare the effect of dates, grape seed and dill seed extracts on the PPH rate in women in the fourth stage of labor.

Two hundred eligible multiparous women visiting the maternity ward in Hamadan for normal delivery participated in this double-blind parallel-group clinical trial. They were randomly divided into four 50-member groups of experiment (3 groups) and control (1 group). The data were collected using a researcher-made questionnaire. In the experimental groups, in addition to routine care and oxytocin administration, the mothers received a capsule containing 15 mg of dill seeds extract or 20 mg of grape seed extract or 5 g of dates extract immediately after the delivery, and then their hemorrhage rates were measured one and two hours after delivery. The control group received routine care, oxytocin, and placebo. Data were analyzed in SPSS 21.

The hemorrhage changes in the placebo group were much less than the intervention groups at 1 and 2 hours after delivery, and the four groups had a significant difference in terms of hemorrhage in both hours (p <0.001). The overall difference between the dates extract group and the placebo and grape seed groups was also statistically significant (p <0.05).

All three extracts of dates, grape seed and dill seeds, especially dates, can be effective in PPH reduction.

IRCT20120215009014N300.