None listed
Conditions
Interventions
Intervention1: Hormonal Balancing Brew: consumed orally, twice daily, in the form of an herbal tea for 90 days.
Control Intervention1: NIL: NIL
Sponsors
SUCHEETAH HEALTH FOODS PRIVATE LIMITED
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female of age within the range of 18 to 35 years 2. Participants must have irregular menstrual cycles, defined as follows: less than 24 days and/or more than 35 days, or cycle-to-cycle variation greater than 7 days for women aged eighteen to twenty-five years and greater than 9 days (26 41 years) in the past 3 cycles, or at least three missed periods in the past 6 months. 3. No hormonal medication in past 3 months 4. BMI between 19 and 30 kg/m without any comorbidity 5. Willingness to consume the Hormone Balancing Brew for the entire study period 6. Willingness and ability to comply with the diet and lifestyle recommendations for the entire duration of the study.
Exclusion criteria
Exclusion criteria: 1. Women using or had used any herbs, dietary supplements, medicines or hormonal therapy that contained estrogenic compounds 2. Use of prescribed medication (antibiotics, steroids, insulin sensitizing drugs, oral contraceptives); 3. Known case of polycystic ovary syndrome (PCOS) or polycystic ovarian disease (PCOD), thyroid dysfunction, endometriosis, uterine fibroids, ovarian cysts or major gynecologic/endocrine disorder 4. Hemoglobin more than 10g/dL history of malignancy, significant renal or hepatic disease 5. History of or known case of eating disorders or major psychiatric illness (eg bipolar, major depression) 6. Current pregnancy, lactation, or intention to conceive during study 7.Participants currently taking any of the following supplements for health maintenance or benefits and not willing to refrain: multivitamin-mineral (MVM), B vitamins, fish oil, Ayurvedic or herbal supplements, nutraceutical supplements, fibre supplements etc. 9. Donated blood within two months before study entry, and must not donate blood during the study duration; 10. Any other history, condition, therapy, or uncontrolled intercurrent and chronic illness which could, in the opinion of the investigator, affect compliance with study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in menstrual cycle length and variability from baseline (recall based on three retrospective cycles at screening) to study end. 2. Changes in menstrual cycle parameters over the study period. 3. Change in symptoms such as mood swings, fatigue, bloating, acne, sleep disturbances assessed using 4-point Likert scale (0=Not at all, 1=Mild; 2=Moderate; 3=Severe). 4. Change in the severity, duration, and working ability due to menstrual cramps as measured by WaLIDD scores 5. Change in premenstrual symptoms severity by PSST Timepoint: Screening, Day 30, Day 60, and Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in vital parameters 2. Occurrence of adverse events 3. Compliance and tolerabilityTimepoint: screening, baseline, day 30, day 60, and day 90 | — |
Countries
India
Contacts
Public ContactSuchita A Mukerji
SUCHEETAH HEALTH FOODS PRIVATE LIMITED
Outcome results
None listed