Health Condition 1: N939- Abnormal uterine and vaginal bleeding, unspecified
Conditions
Interventions
None listed
Sponsors
Sava Herbals
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female subjects between the age group of 18-45 (years both inclusive). 2. Female patients diagnosed with irregular menstruation- AUB viz. dysmenorrhea, hypomenorrhea, oligomenorrhea, amenorrhea, menorrhagia, metrorrhagia, menometrorrhagia, polymenorrhea or dysfunctional uterine bleeding (DUB) with non-structural causes for last 3 months which fulfill Enrollment criteria. 3. Subjects willing to provide written informed consent and ready to comply with the study protocol.
Exclusion criteria
Exclusion criteria: 1. Subjects having known organic causes of menstrual abnormalities like polyps, adenomyosis, endometriosis, fibroids, cervical erosion, uterine myeloma, and any malignant or premalignant conditions of uterus and cervix. 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 Hb less than 8 gm%. 5. Subjects with known HIV, cancer, hepatitis B and C conditions. 6. Subjects with one year of history of delivery or within 3 months of abortion. 7. Pregnant and lactating women. 8. History of genitor-urinary surgery, and or other major medical or surgical diseases; which can affect or related with study outcomes. 9. Women of child bearing age, not willing to follow adequate contraceptive methods excluding oral contraceptive pills. 10. Use of corticosteroids or hormones or hormonal drugs within last 1 month from screening visit. 11. Known hypersensitivity to ingredients used in study drugs. 12. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluating number of subjects achieving regular frequency of menstrual cycles i.e. from baseline to the end of treatment.Timepoint: Evaluating number of subjects achieving regular frequency of menstrual cycles i.e. from baseline to the end of treatment by 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.1) Comparative changes in amount of menstrual bleeding as per the recordings in diary cards by assessing average number of pad(s) changed per day during each menstrual cycle till the end of the study 2.2) Comparative changes in abdominal pain (spasm) on VAS scale from baseline to the end of study . 3. 3) Comparative changes in symptoms associated with irregular menstruation (Headache, Nausea, Body Pain, Sweating, Hot flashes, Anorexia, Palpitation, Fatigue, Lethargy, Energy loss, Fainting, Inability to perform daily tasks, Abdominal bloating, Diarrhea, Constipation, Low Back Pain, Breast Tenderness, Mood Swing or Irritability, Lack of Concentration and Stress / Anxiety) from baseline to the end of study. 4.4) Frequency of use of NSAIDs and / or antispasmodic drugs as rescue medications from baseline to end of study visit. 5. global assessment for overall changes and tolerability Timepoint: 90 days | — |
Countries
India
Contacts
Public ContactDr Mauli Vaishnav
Parul Institute of Ayurved
Outcome results
None listed