A randomized double blind comparative clinical trial to evaluate the efficacy of Vacha ( acorus calamus linn.) churna versus Shunthi (zingiber officinale roscoe.) churna in severe grade Premenstrual Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Change in the total score of PMS assessed with DRSP scale
研究概览
简要总结
Title: A randomized double blind comparative clinical trial to evaluate the efficacy of Vacha (Acorus calamus Linn.)churna versus Shunthi (Zingiber officinale Roscoe.) churna in severe grade Premenstrual Syndrome
Abstract:
Introduction: Pre-menstrual syndrome (PMS) and pre-menstrual dysphoric disorder (PMDD) are characterized by cyclic physical, mental, and behavioral changes in women, with PMDD being a more severe form. While the exact cause remains unclear multiple biochemical abnormalities have been implicated. Ayurveda, although lacking direct reference to PMS provides insights into menstrual cycle phases and dosha imbalances. This study aims to evaluate the efficacy of Vacha churna compared to Shunthi churna in managing severe PMS symptoms
Methods: A randomized, double-blind, controlled trial will be conducted at Dhanwantry Ayurvedic College and Hospital, Chandigarh. Seventy-two unmarried women aged 18-25 years with severe PMS/PMDD will be enrolled and randomized into two groups receiving either Vacha churna or Shunthi churna for three menstrual cycles. Outcome measures include subjective criteria assessed through the Daily Record of Severity of Problems (DRSP) scale and the WHO Quality of Life scale along with objective criteria such as weight change. Statistical analysis will be performed using SPSS-21
Results: Primary outcomes will include changes in total PMS scores and sub-scores for mood, behavioral, and physical symptoms. Secondary outcomes will focus on improvements in quality of life. Expected results will be based on inter-group analysis using independent samples t-tests.
Conclusion: This study aims to provide evidence regarding the efficacy of Vacha churna in managing severe PMS symptoms compared to Shunthi churna. If successful, it could offer an alternative treatment option with minimal side effects and better patient acceptance.
Keywords: Pre-menstrual syndrome, Pre-menstrual dysphoric disorder, Vacha churna, Shunthi churna, Ayurveda, Randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 25.00 Year(s)（—）
- 性别
- Female
入选标准
- •Regular menstrual cycle of 21-35 days,Unmarried women age between 18-25years Able to sign consent form and cooperative behavior Severe grade PMS And PMDD Criteria (as per ICD 11 and DSM-V) Symptoms Exist More Than 2 Cycles.
排除标准
- •Irregular cycle Symptoms exists less than 2 cycles History of any drug addiction Patients participating in any other clinical trial 1 month back Currently breastfeeding, pregnant Ovariectomy, abortion, contraceptive usage within 6 months Any history of mental disorder or patient on medication for that Any systemic disorder like hypothyroidism , heart disease, kidney disease , circulatory system disease, malignant disease Any history of allergic to any drug Pelvic pathology diagnosed with USG if any.
结局指标
主要结局
Change in the total score of PMS assessed with DRSP scale
时间窗: Baseline 1st 2nd 2and 3rd cycle
次要结局
- Change in the total score of mood behavioral and physical symptoms separately with DRSP Scale(Improvement in Quality of Life(WHO QOL) -(baseline,3rd cycle))
研究者
kajal
Shri Dhanwantry Ayurvedic College and Hospital