None listed
Conditions
Interventions
Intervention1: Turmeric-Boswellia Formulation (Rhuleave-K) softgel capsule 500 mg: One capsule twice daily during menstrual phase for three menstrual cycles.
Intervention2: Turmeric-Boswellia Formulat
Sponsors
Arjuna Natural Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy female subjects 18 years or older 2. Subject has a history of regular menstrual cycles that typically occurs between every 28 ± 5 days with minimum 3 days of menstrual flow. 3. History of at least 4 consecutive painful periods in the past 6 month 4. WaLIDD score (Working ability, location, intensity, days of pain, dysmenorrhea score) above 5 5. Average menstrual pain score of 50 mm or above on VAS pain scale. 6. Willing for non-pregnant status during entire study period 7. Willing to provide the informed consent form
Exclusion criteria
Exclusion criteria: 1. Subject has a known allergy to any of the ingredients in any of the study medication products Subject has significant co-existing illness, including gastrointestinal, hepatic, renal, neurologic, cardiovascular, psychiatric, endocrine, respiratory, surgical procedure, or other condition that, in the Investigator’s judgment, contraindicates administration of the study medication 2. Subject has a current or 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 subject safety and/or the study data 3. Subject has an ongoing sexually transmitted disease (except for a history of genital herpes or Human Papillomavirus) or has abnormal vaginal discharge 4. Subject is taking mood-altering agents (e.g., antidepressants, sedatives, phenothiazines, or anti-anxiety agents). 5. Subject is pregnant, lactating, or less than 6 months postpartum 6. Subject 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 7. Subject has a history of alcohol intake daily or drug abuse. 8. 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 9. 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 10. Subject with a medical disorder, condition, or history such that could impair the subject’s ability to participate or complete this study in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Menstrual Pain intensity using Visual Analogue Scale. 2. Duration of Menstrual pain (hours) using menstrual pain diary. 3. Severity of dysmenorrhoea using WaLIDD score (Working ability, location, intensity, days of pain, dysmenorrhea score)Timepoint: Baseline, Each menstrual periods with treatment till trial completion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Associated menstrual symptoms measured using symptoms severity scale.Timepoint: Baseline, Each menstrual periods with treatment till trial completion.;Menstrual characteristics using the menstrual pain diary .Timepoint: Baseline, Each menstrual periods with treatment till trial completion.;Treatment emergent Adverse events (TEAE) evaluation, and hypersensitivity.Timepoint: Throughout the study duration | — |
Countries
India
Contacts
Public ContactDr Giby Abraham
Arjuna Natural Private Limited
Outcome results
None listed