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临床试验/CTRI/2024/02/063315
CTRI/2024/02/063315招募中3 期

Management of Polycystic ovarian syndrome (PCOS) with multimodal Ayurveda treatment- A single arm prospective clinical trial

Nilofar Shaikh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月10日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
regular menstrual cycle

研究概览

简要总结

Polycystic ovary syndrome (PCOS)  is one of the most common endocrine and metabolic   disorders affects an estimated 8–13% of reproductive-aged women.1 Prevalence of PCOS in India ranges from 3.7 to 22.5 per cent depending on the population studied and the criteria used for diagnosis. 2 Polycystic ovary syndrome (PCOS) is a complex condition characterized by elevated androgen levels, menstrual irregularities, and/or small cysts on one or both ovaries.Clinical manifestations of this syndrome such as irregular menstrual cycle, acne or oily skin, excessive hair on the face or body, male-pattern baldness or hair thinning, weight gain, infertility, biochemical and hormonal disturbances has been widely described. Yet, these symptoms are often related to deterioration in the woman’s self-esteem and self-image and may affect their health-related quality of life (HRQoL), particularly in relationship with psychosocial domains3. Ayurveda understands a disease based on the Doshas** and Dushyas involved in disease manifestation. Hence, the specific nomenclature of the diseases is not much essential. There is no direct reference to PCOS in Ayurveda, but the symptoms can be seen in conditions mentioned in Ayurveda literature like Artava Kshaya4*, Ksheena Artava*5 and Pushpaghni jathaharini6. As per the WHO; “There is no cure for PCOS, but treatments can improve symptoms. Contraceptive pill can help to regulate the menstrual cycle and reduce symptoms. Other medicines can reduce acne or unwanted hair growth caused by PCOS.  In-vitro fertilization (IVF) may be used but it has some risks.”7 Non-promising management with its additional adverse effect is a big challenge in the conventional medical care for PCOS.Patients are seeking alternative and complimentary therapy to overcome this challenge. In present clinical study the oral administration of SJ Powder(Combination of Shatapushpa,Jatamansi),  Pathadi Kwatha, Kanchanara Guggulu, and Nasya (Nasal instillation)of Shatapushpa Taila have been attempted to evaluate their effect in selected cases of PCOS.

研究设计

研究类型
Interventional
分配方式
Na
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 with any 3 or more clinical features of PCOS like; Oligomenorrhoea: Menstrual cycle interval: 35-90 days, Acne/ oily skin ,Acanthosis nigricans, Excessive hair on the face or body (Hirsutism ), Male-pattern baldness or hair thinning.
  • Weight gain (BMI- 25.0—29.9).

排除标准

  • Age: below 18 years and above 40 years Sex:Male.

结局指标

主要结局

regular menstrual cycle

时间窗: baseline,12wks,16wks

次要结局

  • No multiple follicles in(ovaries/ ovarian volume will decrease)

研究者

发起方
Nilofar Shaikh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Nilofar Shaikh

JS Ayurveda Mahavidhyalaya

研究点 (1)

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