Health Condition 1: null- Primary dysmenorrhea Health Condition 2: N944- Primary dysmenorrhea
Conditions
Interventions
Intervention1: Go-Go YIN oil: Natural- plant extract based oil blend
The subjects will be instructed to start applying the product 2 days prior to tentative start of the menstrual cycle and will conti
Sponsors
GODS OWN STORE
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants must be single females, aged 18-20 years old with regular cycles lasting three to seven days. Subjects must have a negative pregnancy test. Pregnant patients or individual with history of pregnancy will be excluded from the study. 2. Subjects suffering from primary dysmenorrhea with a pain level >5 (severe pain) on a visual analogue scale and are not undergoing treatment for the pain. 3. The menstrual discomfort experienced should not be due to secondary dysmenorrhea and the Subjects should not be suffering from any systemic or gynaecologic disorders. 4. Participants should be willing to sign a written consent for participation in the study and undergo a baseline interview. 5. Participants must be willing to commit to medication dosing and assessment visits for evaluation. 6. Participants must be willing to refrain from taking analgesics from the outset of the study until second phase evaluation (if patient force to take allopathic medicine, subject will be dropped from the study). 7. Participants must agree that during the study they will refrain from taking any new herbal supplement and prescription or non-prescription medications without prior approval of the research team. 8. Participants must agree to take healthy diet and life style
Exclusion criteria
Exclusion criteria: 1. Participants with known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, pelvic inflammatory disease (PID), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, inflammatory bowel disease, and irritable bowel syndrome). 2. Single or married subjects who are pregnant or have borne children. 3. Participants with a history of or current any kind of hormonal therapy during the last 6 months. 4. Participants with evidence or history of significant systemic or gynecological disorder. (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded). 5. Participants weighing less than 50 kg and malnourished. 6. Patients reporting use of analgesics during the study period. 7. Participant with known allergies to the main components of the test product or placebo. 8. Any participant who is not able to give adequate informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. reduction of menstrual cramps and 2. reduction in abdominal/pelvic pain within 30 minutes of the application of Go-Go Yin essential oil blend during the first three days of menstruation as compared to the placebo. 3. Reduction in the duration of menstruation and/or 4. Regulating excessive menstrual bleeding and improve pelvic health. Timepoint: Baseline Visit (Assessment Visit 1) Day 4 menstrual cycle 1 Assessment Visit 2 Day 4, menstrual cycle 2 Assessment Visit 3 Day 4, menstrual cycle 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse EventsTimepoint: Baseline Visit (Assessment Visit 1) Day 4 menstrual cycle 1 Assessment Visit 2 Day 4, menstrual cycle 2 Assessment Visit 3 Day 4, menstrual cycle 3 | — |
Countries
India
Contacts
Public ContactDr Anit Singh MD
Clinical Research Network India
Outcome results
None listed