Use of Releeva 5 in menstrual irregularity

Phase 3

Completed

Brief Summary: A total of 90 female study participants who are clinically diagnosed to have primary dysmenorrhea will be included in the study. The selection of the patients will be based on initial screening and study criteria.

Group 1- Participants with Primary dysmenorrhea will take one tablet of Releeva 5 premenstrual syndrome tablet orally thrice daily 3 days before menses followed by **Releeva 5 Herbal Tea Granules extract** twice daily for a period of 5 days during the menstrual cycle.

Group 2 - Participants with Primary dysmenorrhea will take one tablet of Releeva 5 premenstrual syndrome tablet orally thrice daily 3 days before menses followed by topical application of **Releeva 5 cramp relief** **Roll-on oil**on the pain affected lower abdomen, thigh and lower back four times daily for a period of 5 days during the menstrual cycle.

Group 3 - Participants with Primary dysmenorrhea will take tablet MEFTAL-SPAS orally 2 times daily for a period of 5 days during the menstrual cycle.

The primary and secondary outcome measures will be monitored over a period of 5 days and follow up for 1 month.

Recruitment & Eligibility

Inclusion Criteria

1.Female participants between the age of 18-45 years (both inclusive) with regular menstrual cycles (21â€“35 days) who are clinically diagnosed to have primary dysmenorrhea.
2.Subjects with stable vitals like pulse and blood pressure 3.Patient should have not participated in any other clinical trial during the past 3 months.
4.Participants who are willing to give written, signed and dated informed consent to participate in the study.

Exclusion Criteria

1.Secondary dysmenorrhea 2.Presence of any other Gynaecological diseases.
3.Pregnant or breastfeeding or planning to become pregnant during the study period.
4.Known case of Hypersensitivity to Investigational drug content.
5.Patients suffering from abnormal haematological or biochemical (renal & liver function) blood parameters.
6.Received any other investigational medicine within 7 days prior to screening which can interfere with investigational product activity 7.Suffering from any illness which will interfere with present study as decided by clinical investigator 8.Any condition decided as unfit for study by Clinical investigator.

Primary Outcome Measures

Name	Time	Method
2. Changes in clinical global impression scale(CGI)	Day 1 to day 5
1. Change from baseline in menstrual pain intensity measured by Pain VAS Scale (0-10)	Day 1 to day 5
3. Changes from base line in following laboratory parameter(s):	Day 1 to day 5
Prostaglandin (PGF2Î±), Hs-C Reactive Protein, ESR, Serum fibrinogen and Complete Blood Count	Day 1 to day 5

Secondary Outcome Measures

Name	Time	Method
4. Changes from base line in Quality of life- Questionnaires (Short Form Health-12 or 36), Systemic symptoms (VMS)	5. Duration of pain relief in hours (After medication)

Locations (1): PM Medical Centre
🇮🇳
Vellore, TAMIL NADU, India
PM Medical Centre
🇮🇳Vellore, TAMIL NADU, India
Dr Ramesh Kannan
Principal investigator
7708925866
srkguruvarshan@gmail.com