Health Condition 1: N944- Primary dysmenorrhea
Conditions
Interventions
Intervention1: Releeva 5 Herbal Tea Granules
Lodhra & Lajjalu each 250 mg with ginger, fenugreek and green tea & chamomile: Take fresh water & allow it to boil and Add entire sachet(5 gm) in 90ml of
Sponsors
Tirupati Life Sciences
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change from baseline in menstrual pain intensity measured by Pain VAS Scale (0-10) 2. Changes in clinical global impression scale(CGI) 3. Changes from base line in following laboratory parameter(s): Prostaglandin (PGF2α), Hs-C Reactive Protein, ESR, Serum fibrinogen and Complete Blood Count Timepoint: Day 1 to day 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) 6. Change in the Pre-menstrual syndrome assessment questionnaire Adverse events and serious adverse events during the study periodTimepoint: Day 1 to day 5 | — |
Countries
India
Contacts
Public ContactDr Ramesh kannan
KI3, CRO (PM Medical centre)
Outcome results
None listed