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临床试验/CTRI/2018/02/012193
CTRI/2018/02/012193进行中(未招募)2 期

Effect Of Unani Formulation in Oligomenorrhoea - An Observational Study

National Institute Of Unani Medicine1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年5月15日最近更新:
适应症

试验速览

阶段
2 期
状态
进行中(未招募)
入组人数
30
试验地点
1
主要终点
Changes in Menstrual pattern:Cycle interval (duration of cycle),Menstruation length (duration of flow)

研究概览

简要总结

Oligomenorrhoea can only be defined arbitrarily as one in which the cycle last longer than 35days. Menstruation may be both infrequent & irregular or may be regularly infrequent. Oligomenorrhoea with a prevalence of 12-15.3% in different studies around the world, is one of the most common type of menstrual bleeding disorder. It is estimated that oligomenorrhoea has prevalence of approximately 10.2% among women of reproductive age group. Oligomenorrhoea is often associated with PCOS which is the most common endocrine disorder in women. Anovulationis present in 60% of women with oligomenorrhoea. Hormone imbalances such as anovulation & androgen excess disorders such as PCOS, adrenal hyperplasia, hyperprolactinemia and thyroid function disorders are the most important causes of oligomenorrhoea.Complications caused by oligomenorrhoea such as infertility, low fertility, malignancies, cardiovascular diseases , diabetes mellitus, hirsutism & acne vulgaris result in problems regarding women’s general health & quality of life. Therefore, timely diagnosis & treatment of these disorders are of utmost important. Hormone therapy is the main treatment of oligomenorrhoea in western or conventional medicine, however the result of a study on infertile women with oligomenorrhoea and PCOD revealed that only 25.6 % of them has good compliance to this treatment, although effective but have their own side effects.Therefore there is need for alternate therapy.

Several drugs are prescribed for qillate tams in unani system of medicine which can be used for treatment. The drug possessing the properties of musaff-i-khoon, mulattife-i-khoon, mudirr-i- bawl wa haiz, munzij balgham and mufatteh sudad etc. are used and are easily available, safe and cost effective. Hence there is need to evaluate the efficacy of unani formulation in qillate tams**.** Keeping all these facts in view, it has been decided to conduct a clinical study on qillate tams to evaluate the efficacy  of unani formulation

研究设计

研究类型
Interventional

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • •Infrequent menstruation of more than 35days or scanty flow both in amount and duration, Hypothyroidism on treatment & PCOD.

排除标准

  • •Patients with hyperprolactinaemia,Uterine synechiae, endometrial tuberculosis, ovarian tumours & malignancy,Hypertension, Diabetes mellitus & other systemic diseases,Pregnant women, lactating women and women on IUCDs.

结局指标

主要结局

Changes in Menstrual pattern:Cycle interval (duration of cycle),Menstruation length (duration of flow)

时间窗: BEFORE AND AFTER TREATMENT

,No. of pads (amount of flow)

时间窗: BEFORE AND AFTER TREATMENT

次要结局

  • Changes in-PBAC,SF-12 survey to assess QOL.

研究者

申办方类型
Research institution and hospital

研究点 (1)

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