STUDY PROTOCOL OF RANDOMIZED OPEN CLINICAL TRIAL OF KANYALOHADI VATI AND KUBERAKSHA VATI IN KASHTARTAVA
Dr. Neha Mamgain*, Dr. G. M. Kavya, Dr. Varsha Saxena
ABSTRACT
Background: Dysmenorrhoea or painful menses is a common gynecological problem adversally affecting the academic, professional performance and overall wellbeing of millions of women and adolescent girls worldwide. Due to the side effects of over-the-counter drugs being used, there is a need to find a therapeutic option for dysmenorrhoea which is safe,natural and effective. Objective: This clinical study is designed to evaluate the comparative efficacy of Kanyalohadi Vati and Kuberaksha Vati in patients with dysmenorrhoea. Materials and Method: This prospective, open-label, randomized trial will be conducted at Faculty of Ayurveda, Main Campus, Uttarakhand Ayurved University, Harrawala. A total of 100 participants will be enrolled in the study. Patients between 16-35 years of age, having dysmenorrhea for more than 3 cycles but no pelvic pathology, having scanty or normal menstrual flow, using analgesics and having Hb levels > 7gm% will be enrolled in the study. The enrolled patients will be randomly divided into two groups. Patients of Group A and Group B will be administered Kanyalohadi Vati and Kuberaksha Vati 2 tablets(500gms) with luke warm water after meals twice a day respectively. The therapy will commence 7days before expected menses and will continue 3 days during menses, consecutively for 3 menstrual cycles. The outcome measures are the changes in chief and associated symptoms of dysmenorrhoea. Patients will be assessed for graded subjective parameters of the same after each menses. Discussion: Ayurveda has been successfully managing dysmenorrhoea with oral drugs and Panchkarma therapies. Research works have been conducted on the efficacy of the trial drugs on dysmenorrhea but a comparative study has not been done. So, it is expected that the results of this trial may suggest a probable condition in which either of the two drugs may offer a better therapeutic option for the effective management of dysmenorrhoea.
Keywords: Kanyalohadi Vati, Kuberaksha Vati, Kashtartava, Dysmenorrhoea, Menstrual disorders.
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