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Brief Summary
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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.
The primary objective is to evaluate the efficacy of Boswellia serrata extract tablets, in patients with primary dysmenorrhoea. Secondary objective is to evaluate the tolerability of Boswellia serrata extract tablets, in patients with primary dysmenorrhoea.
The study is designed to be a 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.
Patients who have primary dysmenorrhoea and who fulfill the Inclusion & Exclusion criteria will be recruited for the study. Volunteers will be enrolled into the study after obtaining written informed consent. Visit 1 (screening and enrollment) - The volunteers will be explained about the study procedures, the risks and discomforts, the investigational products and other alternative treatments. Informed consent will be obtained from subjects who are willing to participate in the study. Demographic details such as date of birth (only for the volunteer), education and occupation details of both the volunteer and her husband will be obtained. Medical, personal, past medication history, menstrual & obstetric history and the details of prior & concomitant medications will be elicited. Ultrasound abdomen will be taken during screening to rule out the causes of secondary dysmennorhoea. The detailed clinical evaluation of dysmenorrhoea will be done. Dysmenorrhoea symptoms will be assessed using the visual analogue scale (score 0-10, where 0 is nil or lowest extreme of the symptom and 10 is severe or the highest extreme of the symptom) for the past 2 cycles. The symptoms will include lower abdominal pain, general abdominal pain, leg pain, back pain, weight gain, headache, nausea, diarrhea, constipation, weakness/feeling faint, feeling of abdominal bloating, polyuria, heart burn, feeling cold/ fever, abdominal cramps etc.,. The emotional symptoms such as frequent outburst of anger, mental instability, laziness, grief, depression, low self esteem etc will be evaluated. Vital parameters (blood pressure, pulse rate) and height, weight & Body Mass Index (BMI) will be obtained and complete physical examination will be performed. Urine pregnancy test will be done. Subjects who fulfill the Inclusion & Exclusion criteria will be enrolled for the study. The enrolled subjects will be provided with the study medications and they will be advised to take the medication two or three times a day (depending on the severity of the menstrual pain) from the first day of the next menstrual cycle. The Investigator will decide upon the dosing frequency depending on the severity of the menstrual pain. If the subjects are menstruating during visit 1 and if they are enrolled for the study, they will be advised to initiate the therapy immediately. Subjects have to self administer the study medication till the menstruation pain stops, in the presence of the Investigator/Study personnel (morning and afternoon doses in Day 1 and Day 2 only). The subjects will be issued a drug compliance diary card and a card to record dysmenorrhoea symptoms (lower abdominal pain, general abdominal pain, leg pain, back pain, weight gain, headache, nausea, diarrhea, constipation, weakness/feeling faint, feeling of abdominal bloating, polyuria, heart burn, feeling cold/ fever, abdominal cramps etc.,) and will be advised to record the details of consumption of medication and dysmenorrhoea symptoms daily. The diary will be recorded by the study personnel before afternoon dose in Day 1 and before the morning and afternoon dose on Day 2 only. Subjects will be advised to report after the end of menstruation or during the interim period if necessary. Subjects will be instructed to bring the drug compliance diary card and card to record dysmenorrhoea symptoms during the follow up visit along with the medication strip / container. In unavoidable circumstances, if the subjects do not complete the diary cards properly, the information can be obtained from them and recorded by the designated study personnel. Visit 2 (Day 2) The subjects should visit the site the next day for administration of investigational product. The following will be assessed and recorded. -Compliance diary card will be collected. -Card to record dysmenorrhoea symptoms will be evaluated and collected. -Concomitant medications will be recorded and particular attention will be provided to capture the usage of non-study analgesics such as ibuprofen, mefanamic acid, paracetamol, naproxen, etc. -Adverse events will be monitored. Visit 3 (Post-treatment follow up) The subjects should visit the site at the end of menstruation period. The following will be assessed and recorded. -Compliance diary card will be collected. -Card to record dysmenorrhoea symptoms will be evaluated and collected. -Dysmenorrhoea symptoms and emotional problems will be evaluated. -Concomitant medications will be recorded and particular attention will be provided to capture the usage of non-study analgesics such as ibuprofen, mefanamic acid, paracetamol, naproxen, etc. -Adverse events will be monitored. -Patient and physician’s global assessment of efficacy and tolerability will be done.
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