Health Condition 1: N926- Irregular menstruation, unspecified
Conditions
Interventions
None listed
Sponsors
Ari Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Female patients diagnosed with irregular with non-organic causes for last 3 months. 2) Females willing to provide written informed consent and ready to comply with study protocol.
Exclusion criteria
Exclusion criteria: 1) Subjects having organic causes of menstrual abnormalities like uterine myeloma, pelvic inflammatory disease adenomyosis, polyps, fibroids, endometriosis, cervical erosion and PCOS (as diagnosed by USG). 2) Subjects having clinical signs of hyper-andronism. 3) Subjects having known systematic illness like uncontrolled hypertension, uncontrolled diabetes mellitus, renal disease, tuberculosis, liver disorder, coagulation disorder, hypothyroidism, hyperthyroidism, hirsutism, Addison disease and or Cushing disease. 4) Subjects with known HIV, cancer, hepatitis B and C conditions. 5) Subjects with one year of history of delivery or abortion. 6) History of genitor-urinary surgery, and or other major medical or surgical diseases; which can affect or related with study outcomes. 7) Pregnant and lactating women. 8) Women of child bearing age, not willing to follow adequate contraceptive methods excluding oral contraceptive pills. 9) Use of corticosteroids or hormones or hormonal drugs within last 1 month from screening visit. 10) Use of any other investigational drug within 1 month prior to screening visit. 11) Subject who are not willing to refrain from the use of any Ayurvedic, Homeopathy, Unani, Siddha medicine, and Nutraceutical and food supplements for menstrual irregularity during trial duration. 12) Known hypersensitivity to ingredients used in study drugs. 13) Other conditions, which in the opinion of investigators, make patient unsuitable for enrolment or could interfere with her participation in, and completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects achieving regular frequency of menstrual cycleTimepoint: Day 0, Day 30, Day 60, Day 90 and Day 120. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Number of subjects achieving regular menstrual bleeding days 2) Changes in amount of menstrual bleeding 3) Abdominal pain (spasm) on VAS 4) Changes in symptoms associated with irregular menstruation 5) Frequency of use of NSAIDs and / or antispasmodic drugs as rescue medications 6) Global assessment for overall change by physician and by patient. 7) Global assessment of tolerability of study drugs 8) Changes in safety laboratory parameters Timepoint: Day 0, Day 30, Day 60, Day 90 and Day 120. | — |
Countries
India
Contacts
Public ContactDr Sanjay Nipanikar
Ari Healthcare Pvt. Ltd.
Outcome results
None listed