A randomized open labelled controlled Clinical study to evaluate the efficacy of Finger Millet (Ragi) and Flax Seeds (Atsi) in the Management of Perimenopausal Syndrome
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Improvement in the subjective parameters of Perimenopausal syndrome like hot flushes,
研究概览
简要总结
The word menopause is derived from the greek word “mens” for month and “pausis” for cessation. Menopause means permanent cessation of mensuration at the end of reproductive life due to ovarian follicular inactivity. Menopause is divided into two stages perimenopause and post menopause. Perimenopause means around menopause and refers to the time during which the body makes a natural transition to menopause. During this transition, the ovary produce less hormone, causing the menstrual cycle to become erratic or irregular. Climacteric is a transitional phase of weaning of ovarian activity before menopause. Sign and symptoms of this climacteric phase may endure for 6 months to 5 years or even longer. During perimenopause there is gradual decrease in both amount and duration. It may be spotting or delayed and ultimately leads to cessation. Menopause is genetically predetermined .It is not related to the number of pregnancies ,race,socioeconomic education, height, weight ,age at menarche or age at last child birth. In ancient Ayurveda menopause is related with the term Rajonivruti which is also derived from the word Rajah and Nivruti cessation of artava pravurti.According to Acharya Sushruta and various other references 50 years is mentioned as the age of Rajonivruti. when the full body is accompanied by vasomotor ,psychological ,genital locomotor and GIT related symptom.. As we all know diet plays a very major role in prevention of disease in the prevention of disease according to concept of Swasthsya Swastahya Rakshanam which is the primary goal of Ayurveda. Finger millet (Ragi) belonging to the family Poaceace .Ragi contains 30 times much calcium as rice namely 344mg/100 gm which plays a major role in bone development and maintainance as well as in the functioning of nerves and muscle. Finger millet seed coat matter which is a rich source of dietary fibres and phenolic compound were found to exhibit blood glucose and cholesterol lowering and nephroprotective property. Flax seeds (ATSI) is one of the richest source of lignans which are phytoestrogens .These phytoestrogens are present in fibre rich plants like cereals. Flax sseds contains 800 times more lignanas as compared to other food products like legumes. Behaviour of lignans depends upon the biological levels of oestradiol .linseed are rich in omega-3 fatty acids which reduce hypertension and triglycerides level.
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
- 35.00 Year(s) 至 55.00 Year(s)(—)
- 性别
- Female
入选标准
- •1.Patients having age 35 to 55 years.
- •2.Patients who are having symptoms of perimenopausal syndrome.
- •3.Patient who are willing to participate in the trial.
- •4.Patient who is having osteopenic changes.
排除标准
- •1.Known case of carcinoma.
- •2.Surgical history of menopause i.e.hysterectomy 3.Patient is having mental illness.
- •4.Patient having diabetes mellitus.
- •5.Patient is having uncontrolled hypertension,kidney disorder.
- •6.Patient on prolonged (>6 weeks medication on corticosteroids ,antidepressant, anticholenrgics or any hormone replacement therapy or any other drug therapy that may have any influence on the outcome of study.
- •7.Patient having history of smoking,alcoholics and drug abusing.
- •8.Patient having any respiratory issues like asthma,COPD etc.
- •9.Patient who are not willing to participate in the trial.
结局指标
主要结局
Improvement in the subjective parameters of Perimenopausal syndrome like hot flushes,
时间窗: follow up for the subjective parameters 1st month, 2nd month, 3rd month and two months after the trial. | Telephonically once a week.
fatigue,pain in joints etc
时间窗: follow up for the subjective parameters 1st month, 2nd month, 3rd month and two months after the trial. | Telephonically once a week.
次要结局
- Quality of life of patient will be improved.(Improvent in the symptoms of Perimenopausal symptoms.)
研究者
Dr Kavita
Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra
