Effect of Saleekha and Majeeth in Polycystic Ovarian disease. An open Observational study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- changes in subjective parameter
研究概览
简要总结
Polycysticovary syndrome (PCOS) is defined as a combination of hyperandrogenism (hirsutismand acne) and anovulation (oligomenorrhorea, infertility, and dysfunctionaluterine bleeding) with or without presence of polycystic ovaries on ultrasound.Acanthosis nigricans most commonly observed in the neck and intertriginous areassuch as armpit, groin and inframammary region7.PCOS is the most common female endocrinologic disorder, in which ovaries become enlarged with manycysts which are in fact small undeveloped follicles. Over time there isthickening and fibrosis of the ovarian casing which prevents any follicleswhich do ripen from being released8. It has been considered a progressivemultiglandular endocrinopathy where the balance of the hypothalamic pituitaryadrenal ovarian axis is disturbed, resulting in failure of the cyclicreproductive mechanism9. Ovulatory dysfunction is typically indicated byunpredictable menses that occur at less than 21-day or greater than 35-day intervalhowever, regular menses that occur every 21 to 35days10.
The Rotterdam criteria indicated PCOS to be present if any 2 of the3 criteria are met.
1.Oligovulation/anovulation.
2.Clinical andbiochemical signs of hyperandrogenism.
3.Polycysticovarian morphology(PCOM)seen on ultrasound11.
To evaluate themenstrual flow PBAC a visual representation of blood loss is used12.
SF-12 is amultipurpose short form survey with 12 questions, which are combined, scored,weighted to create two scales that provide glimpses into mental and physicalfunctioning and overall health related quality of life13.
In unani systemof medicine the disease has not been defined under the term of PCOS; as thedisease has been discovered recently. The description of the disease has comeunder the heading of ‘Ihtibase al- Tamth’‘obesity’, phlegmatic disorder, uqr. Amenorrhoea mostly occurs in fair complexionand phlegmatic temperament female. According to Hippocrates and Galen a womenwith amenorrhoea develops masculine characteristic, male pattern of hair overthe body, beard , hoarseness of voice, mostlythose female who are less muscular with prominent veins.14 Amenorrhoea which is caused by domination of khilte-balghamincreases the viscosity*.* Leading to obesity then treat by mundij-i-balghum and hot emmenagogue drugs such as maulusul and poste khyarshamber, mushktramashih, persheoshan, sudab, babuna15 etc which arewidely used. Out of these compound formulation prepared with majeeth, saleekha 16isselected to prove its efficacy in PCOD, as this formula possess the properties of *musakkhin,mulattif, muhallil-i- awram , mudirr-i-bawl wa hayd, mufattih-i-sudad, muqawwi-i-mi’dawa jiger kasire-i-riyah, munaqiye-i- rhem ,munnaqiye-i jiger, munaffith-i-balgham,mu’arriq, muwalid-i- sheer.*4,5,6 The unani formulation is beingmore potent is selected for the study, in the management of PCOD scientifically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)(—)
- 性别
- Female
入选标准
- •Oligomenorrhoea or amenorrhoea.
- •USG finding of PCOD.
排除标准
- •Endometrial tuberculosis.
- •Malignancies.
- •Systemic and endocrine diseases.
- •Pregnancy, lactation and on contraceptive.
结局指标
主要结局
changes in subjective parameter
时间窗: Nature of cycle, duration of cycle, duration of flow, amount of flow. | Clinical sign of hyperandrogenism. | obesity
次要结局
- PBAC score(SF-12 survey to assess QOL)
