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临床试验/CTRI/2024/03/064419
CTRI/2024/03/064419尚未招募2 期

Effect of Triphala Guggulu orally along with Darvi Taila Yoni Pichu in the management of Chronic Cervicitis

Faculty of Ayurveda Institute of Medical Sciences BHU1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Based on Subjective and Objective criteria and Laboratory investigations

研究概览

简要总结

Gynaecological infections are common worldwide. Disease of the cervix are common in almost all sexually active women as cervix is the most common site of genital infection. Cervicitis is an inflammation of the uterine cervix, most often caused by infection. It is a clinical syndrome characterized by the presence of a purulent or muco-purulent discharge that is visible in the endocervical canal or that can be detected with an endocervical smear. Additionally, other clinical signs of inflammation, such as persistent endocervical bleeding (intermenstrual or post-coital vaginal bleeding) which can be induced by the gentle passing of a cotton swab through the endocervix can indicate cervicitis. Although medicines at present are well tolerated by majority of patients and there are no major adverse effects, the search is always going on to explore more effective medicine.Ayurveda considers that all gynecological disorders are caused by vitiation of vata dosha and are mainly described under Yoni vyapada. In present study an attempt has been made to correlate Cervicitis with yoni rogas mentioned in Ayurvedic classics.It is anticipated that the combined effect of Oral Triphala Guggulu administration along with application of Darvi Taila Yoni pichu will demonstrate significant improvements in the management of Chronic Cervicitis.

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
20.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • Only married women of different age group and parity.
  • Patients presenting with at least any 3 of the following clinical signs and symptomatology of chronic Cervicitis like.
  • a. Patients presenting with mucopurulent discharge p/v and endocervical bleed. b. Patients having inflammatory Cervical Pap smear. c. Patients presenting with clinical features of dyspareunia and cervical tenderness. d. Patients presenting with clinical features of cervical congestion /strawberry cervix. e. Patients presenting with intermenstrual/ post coital bleeding. f. Patients presenting with other symptoms of cervicitis like back ache and lower abdominal pain.

排除标准

  • Unmarried
  • Pregnant women and Patients suffering from any specific organic lesions such as Tuberculosis, acute or chronic respiratory diseases, cardiac diseases, renal diseases, Diabetes mellitus, Hypertension etc.
  • Women with carcinoma of cervix, benign or malignant growth of reproductive tract, any degree of genital prolapses.
  • Patients having their HIV and VDRL reactive.
  • Patients with Cervical Pap smear showing either CIN or papilloma virus infection or invasive malignancy.
  • Patients having Acute cervicitis.
  • Patients having Acute Pelvic inflammatory disease.
  • Patients with h/o surgery of cervix.

结局指标

主要结局

Based on Subjective and Objective criteria and Laboratory investigations

时间窗: 3 Follow ups with equal interval of 15 days

Subjective criteria:

时间窗: 3 Follow ups with equal interval of 15 days

ï‚· Vaginal discharge

时间窗: 3 Follow ups with equal interval of 15 days

ï‚· Post coital bleeding

时间窗: 3 Follow ups with equal interval of 15 days

ï‚· Back ache

时间窗: 3 Follow ups with equal interval of 15 days

ï‚· Inter menstrual spotting

时间窗: 3 Follow ups with equal interval of 15 days

ï‚· Dyspareunia

时间窗: 3 Follow ups with equal interval of 15 days

Objective criteria:

时间窗: 3 Follow ups with equal interval of 15 days

ï‚· Cervical Congestion

时间窗: 3 Follow ups with equal interval of 15 days

ï‚· Cervical discharge

时间窗: 3 Follow ups with equal interval of 15 days

ï‚· Cervical tenderness

时间窗: 3 Follow ups with equal interval of 15 days

ï‚· Contact bleeding

时间窗: 3 Follow ups with equal interval of 15 days

Laboratory investigations

时间窗: 3 Follow ups with equal interval of 15 days

ï‚· Positive inflammatory Pap smear

时间窗: 3 Follow ups with equal interval of 15 days

ï‚· Positive endocervical swab culture

时间窗: 3 Follow ups with equal interval of 15 days

ï‚· Colposcopy

时间窗: 3 Follow ups with equal interval of 15 days

次要结局

  • Reduced inflammation ,alleviated symptoms and improved quality of life among study participants(3 follow ups with Regular interval of 15 days.2 follow ups with medication and 1 follow up without medication)

研究者

发起方
Faculty of Ayurveda Institute of Medical Sciences BHU
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Anjana M C

Banaras Hindu University

研究点 (1)

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