A Clinical Study to Evaluate the Efficacy and Safety of OLNP-06 versus Placebo in Subjects with Primary Dysmenorrhea

Not yet recruiting

Brief Summary: Primary dysmenorrhea is oneof the most prevalent gynaecologic disorders, affecting more than half of allwomen of reproductive age. Symptoms of dysmenorrhea can be incapacitating andwomen experiencing severe symptoms of dysmenorrheal are unable to engage innormal activity and experience increased absence from school or work. Previousstudies have reported that the inhibition of COX-2 by nonspecific non-steroidalanti-inflammatory drugs (NSAIDs) decreases prostaglandin synthesis,contributing to their antipyretic and analgesic properties, and making themeffective for ameliorating the severity of menstrual pain in women. This study will evaluate the effect of standardised Ginger extract for the management of symptoms of Primary dysmenorrhea

Recruitment & Eligibility

Inclusion Criteria

Healthy Female subjects 18 â€“ 35 years of age Regular menstrual cycle between 21.
35 days with bleeding duration between three to seven days Suffering from primary dysmenorrhea Suffering from menstrual pain within the recent three consecutive months with a maximum VAS score of â‰¥4 Willing to sign the informed consent and comply with study procedure.

Exclusion Criteria

Diagnosis of secondary dysmenorrhea due to pelvic pathology, such as uterine fibroids, adenomyosis, endometriosis, or pelvic inflammatory diseases Female who is lactating, currently pregnant, intention to become pregnant.
Current intrauterine device.
Patient taking regular NSAIDs for some therapeutic indication for pain relief other than menstrual pain.
Evidence or history of clinically significant (in the judgment of the Investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, or malignancies.
History of psychiatric disorder that may impair the ability of subjects to provide written informed consent Metrorrhagia with menstrual cycles less than 21 days or oligomenorrhea with cycles over 40 days.
Oral contraceptives or other hormonal treatment use within the past three months.
Subject who is having allergic to ginger.

Primary Outcome Measures

Name	Time	Method
Mean Change from baseline in	Day 0, Week 4, week 8
Maximum Dysmenorrheic Pain VAS Score	Day 0, Week 4, week 8

Secondary Outcome Measures

Name	Time	Method
Mean Change from baseline to end of trial in	oVMS

Locations (1): Chennai Meenakshi Multispeciality Hospital
🇮🇳
Chennai, TAMIL NADU, India
Chennai Meenakshi Multispeciality Hospital
🇮🇳Chennai, TAMIL NADU, India
Dr R Vani Raj
Principal investigator
04442938902
rvani.raj57@gmail.com