An open label double arm randomized controlled clinical study on the efficacy of Kalajaji taila orally in Artava Kshaya, Oligohypomenorrhea
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Significant reduction in signs and symptoms of Artava Kshaya, oligohypomenorrhea based on grading.
研究概览
简要总结
An open label double arm randomized controlled clinical study on the efficacy of Kalajaji taila orally on Artava Kshaya, Oligohypomenorrhea in females of age group 18-40 years for a period of 3 consecutive menstrual cycles. During the study period 40 women will be recruited and divided into two groups, group A(trial drug) and group B(control drug) with 20 women in each group. Group A will receive Kalajaji taila and group B will receive Hingwadi taila in the dosage of 10ml before food in the morning for 2 consecutive menstrual cycles except on the days of menses followed by one follow up menstrual cycle. Clinical assessment will be done after each menstrual cycle for 3 cycles and statistical analysis will be done after every cycle.
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 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •PATIENTS WILLING TO BE PART OF TREATMENT OF ARTAVAKSHAYA, OLIGOHYPOMENORRHEA.
- •PATIENTS FULFILLING THE CARDINAL SYMPTOMS OF ARTAVAKSHAYA, OLIGOHYPOMENORRHEA.
- •WOMEN OF AGE GROUP 18- 40 YEARS.
排除标准
- •MARKED ANEMIA (HB LESSER THAN 7G).
- •SUBJECTS ON ORAL CONTRACEPTIVE PILLS, INTRA UTERINE CONTRACEPTIVE DEVICES.
- •SUBJECTS SUFFERING FROM ANY SYSTEMIC ILLNESS SUCH AS HYPERTENSION AND DIABETES MELLITUS.
- •LACTATING WOMEN.
结局指标
主要结局
Significant reduction in signs and symptoms of Artava Kshaya, oligohypomenorrhea based on grading.
时间窗: Baseline, 3 months
次要结局
- Improved quality of life & prevent recurrence in patients diagnosed with Artava Kshaya, oligohypomenorrhea.(Baseline, 3 months)
研究者
Dr Pratheeksha M
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Anchepalya, Bengaluru