Clinical Assessment of Herbal Formulation in Reducing Oxidative Stress Causing Spermatogenetic Disorders Using the Ros, D- Roms and Mda Tests

Abstract

Background: Several Ayurvedic textbooks describe Sida cordifolia Linn. and Glycyrrhiza glabra Linn. for their anti-inflammatory, antipyretic, antioxidant and sexual properties. After obtaining good results in treatment of male sexual disorders during pre-clinical studies, this clinical trial was taken up to assess the antioxidant properties responsible for spermatogenetic activity of aqueous extract of roots of these two plants. 
 Methods: The study uses subjective evaluation of primary symptoms, estimation of Testosterone levels, sperm analysis and evaluation of oxidative stress levels for assessing the therapeutic efficacy of research formulation through placebo controlled clinical trials on 80 males having lack of sexual desire and non-satisfactory sexual life divided in four study groups. Group I was the control group while Group II received Sida cordifolia Linn., Group III Glycyrrhiza glabra Linn. and Group IV was administered both these plants mixed equally. The tests for assessment of oxidative stress levels include the d-ROMs test, ROS determination by ELISA Sandwich kit and the determination of MDA level by ELISA method test.
 Results: The three drug treated groups (II, III and IV) showed significantly higher therapeutic efficacy in respect of primary symptoms, Testosterone levels and sperm morphology 7 motility as compared to the control group. The decrease in d-ROM value was 2.01% in Group I while it was 16.61%, 12.56% and 20.87% respectively in Groups II, III and IV. Similarly, % decrease in ROS concentration was 4.15, 4.71 and 4.23 in case of Groups II, III and IV while % decrease in oxidative stress marker MDA was 13.58, 12.65 and 13.89 in these treatment groups as compared to very nominal changes in Group I.
 Conclusions: During clinical trial, the three drug treatment groups showed significantly higher therapeutic efficacy as compared to the control group. Among these three groups, Group IV containing both Sida cordifolia Linn. and Glycyrrhiza glabra Linn. exhibited the highest improvement, followed by Group II containing Sida cordifolia Linn. and then Group III containing Glycyrrhiza glabra Linn. The results of the clinical study confirm the antioxidant and spermatogenetic action of the research formulations.
 Key words: Ayurvedic formulation, Sida cordifolia Linn., Glycyrrhiza Glabra Linn., clinical trial, antioxidant