An open label, single arm clinical study evaluating the efficacy and safety of Hormone Balancing Brew alongside lifestyle counselling in women with menstrual irregularity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1. Change in menstrual cycle length and variability from baseline (recall based on three retrospective cycles at screening) to study end.
研究概览
简要总结
Menstrual irregularity is a common gynecological concern affecting women of reproductive age and is often associated with hormonal imbalances, stress, lifestyle factors, and underlying metabolic or endocrine disorders. It manifests as abnormal cycle length, inconsistent bleeding patterns, and associated symptoms such as bloating, mood swings, fatigue, cramps, and acne. While hormonal therapies are commonly used, they are not always well-tolerated for long-term use and may cause undesirable side effects. This has led to increasing interest in evidence-based, plant-derived interventions that are safe, non-hormonal, and align with traditional medicine principles.
Hormone Balancing Brew is a polyherbal nutraceutical formulation comprising FSSAI-approved ingredients such as Mentha spicata (Spearmint), Withania somnifera (Ashwagandha), Asparagus racemosus (Shatavari), Symplocos racemosa (Lodhra), Saraca asoca (Ashoka), and others. These botanicals have demonstrated hormone-modulating, anti-inflammatory, antispasmodic, and adaptogenic properties. Traditional and preliminary scientific evidence suggests that the formulation may help regulate menstrual cycles, reduce PMS symptoms, and improve quality of life without the adverse effects of synthetic hormonal agents.
Pharmacologically, the formulation’s ingredients offer synergistic effects:
- Spearmint reduces free testosterone and supports estrogen balance.
- Ashwagandha modulates the HPA axis and reduces cortisol.
- Shatavari and Ashoka support uterine health and smooth muscle relaxation.
- Daruharidra (Berberine) and Cinnamon improve insulin sensitivity and hormonal detoxification.
- Ginger, Peppermint, and Lemongrass provide antispasmodic, anti-inflammatory, and mood-supporting effects.
This study aims to evaluate the clinical efficacy and safety of the Hormone Balancing Brew in women with menstrual irregularities, assessing its effects on cycle regularity, menstrual symptoms, and overall well-being. A structured clinical approach with lifestyle counselling is expected to enhance outcomes and provide robust data to validate its therapeutic potential.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female of age within the range of 18 to 35 years
- •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.
- •No hormonal medication in past 3 months
- •BMI between 19 and 30 kg/m² without any comorbidity
- •Willingness to consume the Hormone Balancing Brew for the entire study period
- •Willingness and ability to comply with the diet and lifestyle recommendations for the entire duration of the study.
排除标准
- •Women using or had used any herbs, dietary supplements, medicines or hormonal therapy that contained estrogenic compounds
- •Use of prescribed medication (antibiotics, steroids, insulin sensitizing drugs, oral contraceptives);
- •Known case of polycystic ovary syndrome (PCOS) or polycystic ovarian disease (PCOD), thyroid dysfunction, endometriosis, uterine fibroids, ovarian cysts or major gynecologic/endocrine disorder
- •Hemoglobin more than 10g/dL history of malignancy, significant renal or hepatic disease
- •History of or known case of eating disorders or major psychiatric illness (eg bipolar, major depression)
- •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.
- •Donated blood within two months before study entry, and must not donate blood during the study duration;
- •Any other history, condition, therapy, or uncontrolled intercurrent and chronic illness which could, in the opinion of the investigator, affect compliance with study requirements.
结局指标
主要结局
1. Change in menstrual cycle length and variability from baseline (recall based on three retrospective cycles at screening) to study end.
时间窗: Screening, Day 30, Day 60, and Day 90
2. Changes in menstrual cycle parameters over the study period.
时间窗: Screening, Day 30, Day 60, and Day 90
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).
时间窗: Screening, Day 30, Day 60, and Day 90
4. Change in the severity, duration, and working ability due to menstrual cramps as measured by WaLIDD scores
时间窗: Screening, Day 30, Day 60, and Day 90
5. Change in premenstrual symptoms severity by PSST
时间窗: Screening, Day 30, Day 60, and Day 90
次要结局
- 1. Changes in vital parameters(2. Occurrence of adverse events)
研究者
Dr Pooja Digambar Gunjkar
Gunjkar Multispeciality Hospital