Single center, single treatment, open label, prospective clinical trial to evaluate the efficacy and tolerability of Boswellia serrata extract tablets of CavinKare Pvt. Ltd., in patients with primary dysmenorrhoea

CavinKare Pvt Ltd0 个研究点目标入组 15 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•?Female subjects within the age range of 18 to 30 years (both years inclusive).
•?Willingness to provide written informed consent to participate in the study.
•?Subjects, understanding the nature and purpose of the study and who are willing to comply with study procedures.
•?Subjects who are diagnosed to be having primary dysmenorrhoea and having regular cycles (once in 26 to 35 days) in view of the investigator.
•?Subjects who have the symptoms of dysmenorrhoea for the past 6 months.
•?The average score (of last two months) for lower abdominal pain and/or other dysmenorrhoea symptoms in the VAS shall be more than or equal to 7.
•?Body mass index with 18.50 to 30.00 kg/m2

•?History and / or clinical examination suggestive of secondary dysmenorrhoea.
•?Women who are within 6 months of having given a child birth / miscarriage.
•?Pregnant & nursing women.
•?Hypersensitivity to the study medication.
•?Participation in any other clinical study within the previous 30 days before the baseline of this trial.
•?Any concomitant disease or condition that requires any intake of analgesic medication.
•?Any history of major systemic illness and significant gastrointestinal & liver disorders, renal disorders, endocrine abnormalities, cardiovascular, respiratory, neuropsychiatric disorders or any other significant medical illness, in view of the investigator.

发起方

CavinKare Pvt Ltd