None listed
Conditions
Interventions
Intervention1: Turmeric-Boswellia formulation: 2 soft gel capsules of 500 mg as single dose, orally, one day
Control Intervention1: Placebo: 2 soft gel capsules of 500 mg as single dose, orally, one d
Sponsors
Arjuna Natural Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy female participants between 18 and 35 years of age. 2. Participant has a history of regular menstrual cycles that typically occurs between every 21 to 35 days. 3. Participant has a self-reported history of primary dysmenorrhea with at least moderate menstrual cramp pain (based on the categorical pain intensity scale 0-3). 4. Participant is willing to participate in the study and give voluntary informed consent.
Exclusion criteria
Exclusion criteria: 1. Participant has a known allergy to any of the ingredients in any of the study medication products; 2. Participant has significant co-existing illness, including gastrointestinal, hepatic, renal, neurologic, cardiovascular, psychiatric, endocrine, respiratory, surgical procedure or other condition that, in the Investigatorâ??s judgment, contraindicates administration of the study medication; 3. Participant has a current or past history of one or more of the following conditions: secondary dysmenorrhea, pelvic inflammatory disease, urinary tract infection (currently acute or recurrent [defined as more than three per year]), adnexal masses, uterine fibroids, endometriosis, adenomyosis that in the opinion of the Investigator would impact participant safety and/or the study data; 4. Participant has an ongoing sexually transmitted disease (except for a history of genital herpes or Human Papillomavirus) or has abnormal vaginal discharge; 5. Participant requires prescription analgesics, narcotic, non-NSAID (i.e., defined as oral use of 5 or more times per week for greater than 3 weeks) or has routinely taken OTC medications in excess of label recommended instructions for control of dysmenorrhea symptoms; 6. Participant is taking mood-altering agents (e.g., antidepressants, sedatives, phenothiazines, or anti-anxiety agents). 7. Participant does not agree to abstain from taking any analgesic and/or anti- inflammatory approximately 72 hours prior to the anticipated treatment period and throughout the dosing/assessment period. All pain and anti-inflammatory medications including supplements, topical heat or cold, and other products of topical application will be discontinued approximately 72 hours prior to the anticipated dosing for treatment period and throughout the dosing/assessment period; 8. Participant is pregnant, lactating, or less than 6 months postpartum; 9. Participant is currently using an oral contraceptive for less than 3 months, has been on an unstable dose within the last 3 months or has switched from one oral contraceptive to another within the last 3 months of the study; 10. Participant has a history of alcohol intake daily or drug abuse. 11. Participant with a medical disorder, condition or history such that could impair the participantâ??s ability to participate or complete this study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total Pain Relief scores (TOTPAR 6) using pain relief categorical scale (0-4).Timepoint: Each 30 min post-dose censored at 6 h | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Global EvaluationTimepoint: At 6 hours post-dose or immediately before first intake of rescue medication;â?¢Summed Pain Intensity Difference (SPID) over the 6-hour study period (SPID 0-6) using 0-10 NRS â?¢Pain Intensity Difference (PID) scores at each evaluationTimepoint: Each 30 min post-dose censored at 6 h | — |
Countries
India
Contacts
Public ContactDr Giby Abraham
Arjuna Natural Private Limited
Outcome results
None listed