Efficacy of Alabu Modaka as an add on to Bolabaddha rasa in Menorrhagia hypen A Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 24
- 试验地点
- 1
研究概览
简要总结
A Randomized controlled trial is planned to assess the additional effect of Alabu Modaka along with Bolabaddha rasa against Bolabaddha rasa alone. Participants who satisfy the inclusion criteria will be randomly allocated in two groups Group 1 and Group 2 by simple random sampling using computer generated random numbers. In the Group 1, Alabu Modaka along with Bolabaddha rasa will be given and in the Group 2, Bolabaddha rasa will be given. Assessment will be conducted during the first OPD visit and after each bleeding phase of the 1st, 2nd, and 3rd cycles and follow up will be done after the bleeding phase of 4th cycle using PBAC scores. Quality of life will be assessed using the Menstrual Bleeding Questionnaire. Data will be compiled and statistically analysed to draw conclusion.
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
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Prolonged menstrual bleeding of more than 7 days and or or excessive menstrual bleeding with PBAC score greater than 100
- •Participant with Hb greater than 8 g%
- •Participants diagnosed with fibroid uterus
- •Willingness to provide informed written consent.
排除标准
- •Participants with intermenstrual bleeding
- •Bleeding associated with OCP and IUCD
- •Participants diagnosed with any form of malignancy
- •Participants on prolonged medication for systemic illnesses like thyroid dysfunction, diabetes mellitus, severe hypertension, liver cirrhosis, congestive cardiac failure
- •Participants who have received hormonal therapy within the past 3 months
- •Participants with known coagulation disorders.
研究者
Dr Prathiba B
VPSV Ayurveda College Kottakkal