Health Condition 1: N944- Primary dysmenorrhea
Conditions
Interventions
Intervention1: vaginal suppositories: Administer 2 grams of vaginal suppositories intravaginally once during menstruation.
Dosage:
1. First Cycle: Dosage-100 mg of vaginal suppository once during mens
Sponsors
HYD HEMP INDIA PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects willing to give informed consent. 2. Healthy female subjects between the age group of 18- 50 years. 3. Subjects not currently using any medications for menstrual pain relief. 4. History of at least 6 months of menstrual cramping pain which lasts for 2 days in each menstrual cycle.
Exclusion criteria
Exclusion criteria: 1. Subjects having any organic pathology of the uterus and adnexae. 2. HIV, VDRL, HBsAg positive Subjects. 3. Subjects suffering from systemic diseases. 4. Subjects with intra-uterine contraceptive devices. 5. Subjects with menorrhagia and metrorrhagia. 6. Subjects is having menstrual period interval less than 21 days or more than 35 days. 7. Pregnant and breastfeedin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate Change in Visual Analogue Scale score for pain intensity 2. To assess the safety of the vaginal suppositoriesTimepoint: Day1, Day30, Day60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess change in quality of life using the SF-36 Questionnaire.Timepoint: Day1, day3, Day 5 Day 15 | — |
Countries
India
Contacts
Public ContactArpita malgi
Samahitha Research Solutions
Outcome results
None listed