Health Condition 1: K928- Other specified diseases of the digestive system
Conditions
Interventions
Intervention1: Ginger extract: Ginger extract one capsule once daily for 8 weeks
Control Intervention1: Placebo: Placebo One capsule Once daily for 8 weeks
Sponsors
Olene Life Sciences Private Limited
Eligibility
Inclusion criteria
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 >=4 Willing to sign the informed consent and comply with study procedure
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change from baseline in Maximum Dysmenorrheic Pain VAS Score Timepoint: Day 0, Week 4, week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change from baseline to end of trial in oVMS oSymptoms reported during menstruation (Low back pain, fatigue, nausea, headache, diarrhea, vomiting) Timepoint: Day 0, Day 28, Day 56 | — |
Countries
India
Contacts
Public ContactSanjib Panda
Olene Life Sciences Private Limited
Outcome results
None listed