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临床试验/CTRI/2022/10/046666
CTRI/2022/10/046666尚未招募4 期

A prospective open label non randomized clinical trial To Evaluate The Safety And efficacy of Endotone polyherbal capsule in treatment of Endometriosis.

Charak Pharma Pvt Ltd1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年10月31日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
Pain reduction in endometriosis

研究概览

简要总结

Endometriosis is a prevalent disease estimated to affect 10% of women of reproductive age, upto 50% of women with pelvic pain, and 20%-50% of women with reduced fertility. The commonest symptom is pelvic pain, which presents as dysmenorrhea in over 98% of patients with symptomatic endometriosis and non-menstrual pelvic pain. Pelvic pain associated with endometriosis varies greatly in intensity, frequency and duration from patient to patient. Non-menstrual pelvic pain is usually chronic (lasting ≥ 6 months), and it can be intermittent throughout the menstrual cycle or continuous and may present as dull, throbbing, or sharp pain. In addition, the pain related to endometriosis has been shown to impair both work- related and non-work-related daily activities.

For the present study, a polyherbal formulation manufactured by Charak Pharma Pvt. Ltd. will be taken up for the study. The formulation has been standardized after formulating SOPs along with acute toxicity study. The objective of current study is to assess clinical safety and efficacy of the study drug in symptoms associated with endometriosis.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Female 18 to 45 years of age (inclusive) at the time of screening. 2) Women experiencing endometriosis symptoms like pelvic pain, dysmenorrhea, Dyspareunia 3) Women with documented diagnosis of endometriosis by either of the following.
  • a) Laparoscopy or laparotomy b) VAS test score of 1-7 for dysmenorrhea/dyspareunia and/or Pelvic pain due to endometriosis. c) Clinical features, pelvic examination findings d) Diagnosed case of endometriosis by any radio-imaging techniques. 4) Recurrent Endometriosis after surgery.

排除标准

  • Participant having chronic pelvic pain that is not caused by endometriosis 2) Patients with concomitant hormonal treatment, including oral contraceptive pills.
  • Patients with known systemic diseases (e.g., hypertension, diabetes, coronary, renal, and hepatic diseases).
  • Patients with known malignancy.
  • Menopausal women, Pregnancy, Lactating women.
  • Large chocolate cysts.

结局指标

主要结局

Pain reduction in endometriosis

时间窗: 3 months

次要结局

  • Improved quality of life.(6 Months)

研究者

发起方
Charak Pharma Pvt Ltd
申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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