Effectiveness of topical natural oil blend to treat Primary dysmenorrhea

Phase 4

Conditions: Health Condition 1: null- Primary dysmenorrheaHealth Condition 2: N944- Primary dysmenorrhea

Registration Number: CTRI/2018/04/013438

Lead Sponsor: GODS OWN STORE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.reduction of menstrual cramps and <br/ ><br>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. <br/ ><br>3.Reduction in the duration of menstruation and/or <br/ ><br>4.Regulating excessive menstrual bleeding and improve pelvic health. <br/ ><br>Timepoint: Baseline Visit (Assessment Visit 1) Day 4 menstrual cycle 1 <br/ ><br>Assessment Visit 2Day 4, menstrual cycle 2 <br/ ><br>Assessment Visit 3 Day 4, menstrual cycle 3 <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
Adverse EventsTimepoint: Baseline Visit (Assessment Visit 1) Day 4 menstrual cycle 1 <br/ ><br>Assessment Visit 2Day 4, menstrual cycle 2 <br/ ><br>Assessment Visit 3 Day 4, menstrual cycle 3 <br/ ><br>