Health Condition 1: N926- Irregular menstruation, unspecified
Conditions
Interventions
Intervention1: Ayuvita (Forte) Capsule: Ayuvita (Forte) Capsule Contains: Mucuna prurita, Saraca indica, Symplocos paniculata, Glycyrrhiza glabra, Sida cordfolia, Withania somnifera, Asparagus racemos
Sponsors
Welex Laboratories Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Female patients diagnosed with irregular Menstruation (non-organic causes) for over last at least 3 months. 2.Females willing to give informed consent and ready to comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1.Patients having organic causes of menstrual abnormalities like uterine myeloma, pelvic inflammatory disease adenomyosis, polyps, fibroids,Endometriosis, cervical erosion, and PCOS (as diagnosed by USG lower abdomen and pelvis). 2.Patients having clinical and/or biochemical signs of hyper-andronism. 3.Patients having systematic illness like uncontrolled hypertension, diabetes mellitus, renal disease, tuberculosis, liver disorder, coagulation disorder, hypothyroidism, hyperthyroidism, hirsutism, Addison disease and or Cushing disease. 4.Patients with one year of history of delivery or abortion. 5.History of genitor-urinary surgery, and or other major medical or surgical diseases; which can affect or related with study outcomes. 6.Nursing, pregnant or lactating women. 7.Women of child bearing age, not willing to follow adequate contraceptive Methods excluding oral contraceptive pills. 8.Use of corticosteroids or hormones or hormonal drugs within last 1 months of screening visit. 9.Use of any other investigational drug within 1 month prior to screening visit. 10.Patient having known hypersensitivity to any ingredient of the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Number of subjects achieving regular menstruation (bleeding days) at the end of study treatment. 2.Number of subjects achieving regular menstruation (frequency of menstrual intervals) at the end of study treatment Day. Timepoint: Day-7, Day 0, Day 30, Day 60, Day 90, Day 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in amount of menstrual bleeding 2.Changes in abdominal pain 3.Changes in symptoms associated with irregular menstruation 4.Frequency of use of NSAIDs and or antispasmodic drugs as rescue medications 5.Global assessment for overall improvement by subject and investigator at the end of study 6.Post-treatment assessment of tolerability of Ayuvita (Forte) capsule by assessing Adverse Events 7.Changes occurred in laboratory parameters and vitals Timepoint: Day-7, Day 0, Day 30, Day 60, Day 90, Day 120 | — |
Countries
India
Contacts
Public ContactVandana Bade
Target Institute of Medical Education and Research
Outcome results
None listed