A Clinical Study to Evaluate the Efficacy and Safety of OLNP-06 versus Placebo in Subjects with Primary Dysmenorrhea
- Conditions
- Health Condition 1: K928- Other specified diseases of the digestive system
- Registration Number
- CTRI/2022/02/039897
- Lead Sponsor
- Olene Life Sciences Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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 >=4
Willing to sign the informed consent and comply with study procedure
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Change from baseline in <br/ ><br>Maximum Dysmenorrheic Pain VAS Score <br/ ><br>Timepoint: Day 0, Week 4, week 8 <br/ ><br>
- Secondary Outcome Measures
Name Time Method Mean Change from baseline to end of trial in <br/ ><br>oVMS <br/ ><br>oSymptoms reported during menstruation (Low back pain, fatigue, nausea, headache, diarrhea, vomiting) <br/ ><br>Timepoint: Day 0, Day 28, Day 56