Health Condition 1: N944- Primary dysmenorrhea
Conditions
Interventions
Intervention1: Ayurvedic Formulation ( Tablet containing Kunduru, Ashoka and Kasisa): The investigational Product is a herbaceutical product used for the indication of Primary Dysmenorrhea. It is the
Sponsors
Ms Cavinkare Research Centre
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy women ages 18-40 (both ages inclusive) with a history of Primary Dysmenorrhea (onset of symptoms 2. Regular menstrual cycles for atleast 6 months (once in 28-35 days with each cycle lasting a minimum of 3 days.) 3. Subjects with body mass index of 18.50 to 30.00 kg/m2 (Both values inclusive) 4. Subjects who score either â??Moderateâ?? or â??Severeâ?? in the Severity Assessment during Visit 0. 5. Subjects who understand the nature and purpose of the study and who are willing to comply with study procedures.
Exclusion criteria
Exclusion criteria: 1. Known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, salpingitis, pelvic inflammatory disease (PID), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, inflammatory bowel disease, irritable bowel syndrome). 2. Concomitant treatment with oral contraceptives, Gonadotrophinreleasing hormone agonists and antagonists, antiandrogens, gonadotropins, antiobesity drugs. 3. Recent history of abdominal surgery in the last 6 months. 4. Unevaluated gynecological abnormalities inclusive of oncological diagnosis or suspicion (unexplained vaginal bleeding, cervical dysplasia) 5. Gross developmental defect or congenital abnormalities of uterus 6. Patients with uncontrolled hypertension, diabetes or other uncontrolled co-morbidities. 7. Pregnant & nursing women or women who have given birth or had a miscarriage within the last 6 months. 8. Women who have undergone hysterectomy. 9. Any history of major systemic illness and significant gastrointestinal & liver disorders, renal disorders, endocrine abnormalities, cardiovascular, respiratory, neuropsychiatric disorders or any other significant medical illness, in view of the investigator. 10. Perimenopausal and Menopausal women. 11. Known or suspected hypersensitivity to herbal products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Modified Cox Menstrual Symptoms Scale: â?¢Onset of action of Investigational Product: Within 1 hour â?¢Duration of action of Investigational Product: Upto 6 hours After using Investigational Product, 2.Faces Pain Scale- Revised (FPS-R): â?¢Pain score of â?¤ 3 â?¢Extent of reduction of pain by3 score 3.Modified Moos Menstrual Distress Questionnaire (Form T): Total Score of â?¤ 8 4.Quality of Life Questionnaire: Total score of â?¤ 8Timepoint: 1.Modified Cox Menstrual Symptoms Scale: â?¢Onset of action of Investigational Product: Within 1 hour â?¢Duration of action of Investigational Product: Upto 6 hours After using Investigational Product, 2.Faces Pain Scale- Revised (FPS-R): â?¢Pain score of â?¤ 3 â?¢Extent of reduction of pain by3 score 3.Modified Moos Menstrual Distress Questionnaire (Form T): Total Score of â?¤ 8 4.Quality of Life Questionnaire: Total score of â?¤ 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Modified Cox Menstrual Symptoms Scale: â?¢Onset of action of Investigational Product: Within 2 hours â?¢Duration of action of Investigational Product: Upto 4 hours After using Investigational Product, 2.Faces Pain Scale-Revised (FPS-R): â?¢Pain Score of â?¤ 4 â?¢Extent of reduction of pain by 2 score 3.Modified Moos Menstrual Distress Questionnaire (Form T):Total Score of â?¤ 16 4.Quality of Life Questionnaire:Total score of â?¤18Timepoint: 1.Modified Cox Menstrual Symptoms Scale: Before and After use of Investigational Product during painful menstruation. 2.Faces Pain Scale- Revised (FPS-R): Before and After use of Investigational Product during painful menstruation. 3.Modified Moos Menstrual Distress Questionnaire (Form T): Before and After use of Investigational Product during painful menstruation. 4.Quality of Life Questionnaire: Two Times.At Visit 2 as a Baseline and at Visit 3 as improvement metric. | — |
Countries
India
Contacts
Public ContactDr VT Sriraam MBBS MD Pharmacology
M/s Aurous HealthCare Research and Development India Private Limited
Outcome results
None listed