A clinical evaluation of polyherbal formulation in the management of Warm -e- unq-ur-rahem muzmin (Chronic Cervicitis)-An open label single arm study.
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Ayurvedic and Unani Tibbia college and hospital
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- VAS Score (visual analogue scale),PS/PV Examination and PAP Smear will be assessed
概览
简要总结
This study is an open label single arm trial to validate the efficacy, safety of of the extract form of Unani polyherbal formulation in the treatment of warm-e-unq-ur-rahem muzmin (chronic cervicitis) and reducing the symptoms of chronic cervicitis . Common complaints of patients include pelvic pain , vaginal discharge ,lower abdomen cramping ,intermenstrual bleeding, spotting with intercourse or dysuria. Cervix acts as a barrier to protect the uterus from entering infections (i.e bacteria ,viruses), if cervix remain unhealthy there is an increased risk of uterine infections. Chronic cervicitis has become more distressing problem problem, despite advancement of modern science. Chronic Cervicitis that is caused by Gonorrhea or Chlamydia can spread to uterine lining and fallopian tubes resulting in pelvic inflammatory disease (PID). PID is an infection of the female reproductive organs that can cause fertility issues if left untreated.( eg. ectopic pregnancy, adhesions in uterine cavity ,cervix etc. Several variety of medical therapies are available today for its treatment but no treatment promises complete cure and have some short and long term side effects as well, such as conization, cryotherapy and cauterization and antifungal , antibiotics regimens. The long term use of antibiotics lead to various side effects like gastrointestinal upset, nausea vomiting, diarrhea, dizziness and antibiotic resistance may also develop. Therefore search for a safe and effective drug is need of the time especially from herbal treasure. Unani scholars have described principles of treatment for the management of chronic cervicitis and many safe and effective single as well as compound drug drugs in classical Unani literature for the same purpose. In this study , we are planning to use extract form of the Unani polyherbal formulation to evaluate the effectiveness of the this composition of drugs.·
·
·
·
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 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Married women in the age group of 18 to 45 years having vaginal discharge.
- •Patient giving history or complaint of the passage of mucopurulent cervical discharge with or without foul smell.
- •Patient with complaints of lower backache.
- •Patient with complaints of intermenstrual spotting and post-coital bleeding.
- •Patient having symptoms of dyspareunia and dysuria.
- •Patient having complaints of vulval Itching.
- •On P/S examination there may be findings of Nabothian follicles, congestion, and hyperplasia of cervix.
排除标准
- •The patient was unwilling to sign the consent form.
- •The patient has a history of AIDS, syphilis, gonorrhea or any other sexually transmitted disease.
- •History of cardiovascular, renal, liver disease.
- •History of diabetes mellitus .
- •Individuals of alcohol abuse or any other substance abuse.
- •Unmarried and pregnant women.
- •Women having a history of conisation, cryotherapy, and cauterization will also excluded.
结局指标
主要结局
VAS Score (visual analogue scale),PS/PV Examination and PAP Smear will be assessed
时间窗: 12 weeks
次要结局
- Abnormal cervical discharge,(Lower backache, Vulval Itching,)
研究者
Dr.Tanzeela khan
Ayurvedic and unani Tibbia college and hospital