Health Condition 1: null- Female patients suffering from primary dysmenorrhoea
Conditions
Interventions
Intervention1: Boswellia Serrate Extract tablets: Boswellia Serrate Extract tablets : Each uncoated tablets contains Boswellia serrata extract 400 mg
The tablets will be given orally two or three time
Sponsors
CavinKare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: ? 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
Exclusion criteria
Exclusion criteria: ? 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary efficacy measures Number of days with dysmenorrheic pain and its severity (lower abdominal pain, general abdominal pain & back pain) Timepoint: Primary outcomes (Lower abdominal pain, general abdominal pain & back pain) will be measured by Visual Analog scale before administration of each dose and not after the administration of each dose. Measurement of Visual analog scale before afternoon dose will able to assess the efficacy of pain relief of the morning dose, Measurement of Visual analog scale before night dose will able to assess the efficacy of pain relief of the afternoon dose and so on. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy measures 1.Use of rescue medication 2.Number of days with Interference of daily activities and its severity 3.Number of days with headache, nausea, diarrhea, constipation, weakness/feeling faint and severity 4.Treatment compliance 5.Physician & Patients global assessment of efficacy Timepoint: 1 | — |
Countries
India
Contacts
Public ContactDrVariamala
Outcome results
None listed