Health Condition 1: N944- Primary dysmenorrhea
Conditions
Interventions
Intervention1: Ginger extract granules: The intervention is Ginger Extract Granules, 100 mg, administered orally twice daily (morning and evening) after food for 90 days (3 months) in female subjects
Sponsors
India Glycols Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy educated metro women aged greater than or equal to 20 and less than or equal to 30 years. 2. Married women with regular sexual life without childbirth or any abortion. 3. Having primary dysmenorrhea symptoms continuously for at least 2 menstrual cycles months prior to the study screening. 4. Non-allergic to test item. 5. Subjects having not more than one episode of severe dysmenorrhea in a given menstrual cycle. 6. Subjects with self-reported history of primary dysmenorrhea with moderate (VAS Score greater than or equal to 4 to less than or equal to 6) menstrual cramp pain (based on the 10-point Visual Analogue Scale) occurring during four of the past six menstrual cycles. 7. Desirability and comfortability to use menstrual cups throughout the study. 8. Subjects willing to participate in the study. 9. Subjects who are willing to sign the informed consent and participate in the study. 10. Subjects willing to use only condoms as contraceptive method.
Exclusion criteria
Exclusion criteria: 1. Devoid of secondary dysmenorrhea and other fertility-related issues. 2. Subject has a current or past history of severe gastritis, gastrointestinal bleeding or ulceration. 3. Subject has a current or past history of the urinary tract infection. 4. Positive pregnancy test or breastfeeding at screening and prior to dosing. 5. Subjects with previous history of abortion. 6. Subjects with aversion to sexual life or sexual partner. 7. Subjects with hypoactive sexual desire disorder. 8. Subjects with spouse living in different area/ city. 9. Subjects who are single house wives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in dysmenorrhea pain as measured by a Visual Analogue Scale (VAS) and Working Ability, Location, Intensity, Days of Pain, Dysmenorrhea (WaLIDD) scale at menstrual cycle -2, -1, 1, 2, and 3 relative to dosing. Also, number of subjects with reduction in the dysmenorrhea pain will be documented.Timepoint: 1. Baseline (Pre-treatment) 2. 4 weeks after the start of dosing (approximately Day 1 of the 2nd menstrual cycle) 3. 8 weeks after the start of dosing (approximately Day 1 of the 3rd menstrual cycle) 4. 12 weeks after the start of dosing (approximately Day 1 of the 4th menstrual cycle) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change in physical, mood, & behavioral symptoms. 2.Improvement in female sexual function. 3.Improvement in sexual quality of life. 4.Improvement in general wellness. 5.Menstrual fluid flow evaluation. 6.Adverse events & abnormal lab findings. Timepoint: 1. Baseline (Pre-treatment) 2. 4 weeks after the start of dosing (approximately Day 1 of the 2nd menstrual cycle) 3. 8 weeks after the start of dosing (approximately Day 1 of the 3rd menstrual cycle) 4. 12 weeks after the start of dosing (approximately Day 1 of the 4th menstrual cycle) | — |
Countries
India
Contacts
Public ContactDr. Nehru Sai Suresh
Udhbhava Hospital
Outcome results
None listed