Clinical Study on Ayuvita (Forte) Capsule in menstrual irregularities.
- Conditions
- Health Condition 1: N926- Irregular menstruation, unspecified
- Registration Number
- CTRI/2018/03/012614
- Lead Sponsor
- Welex Laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 42
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Number of subjects achieving regular menstruation (bleeding days) at the end of study treatment. <br/ ><br>2.Number of subjects achieving regular menstruation (frequency of menstrual intervals) at the end of study treatment Day. <br/ ><br>Timepoint: Day-7, Day 0, Day 30, Day 60, Day 90, Day 120
- Secondary Outcome Measures
Name Time Method 1.Changes in amount of menstrual bleeding <br/ ><br>2.Changes in abdominal pain 3.Changes in symptoms associated with irregular menstruation <br/ ><br>4.Frequency of use of NSAIDs and or antispasmodic drugs as rescue medications <br/ ><br>5.Global assessment for overall improvement by subject and investigator at the end of study <br/ ><br>6.Post-treatment assessment of tolerability of Ayuvita (Forte) capsule by assessing Adverse Events <br/ ><br>7.Changes occurred in laboratory parameters and vitals <br/ ><br>Timepoint: Day-7, Day 0, Day 30, Day 60, Day 90, Day 120