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临床试验/CTRI/2025/02/080728
CTRI/2025/02/080728尚未招募2/3 期

Randomised Controlled Clinical Trial to Evaluate the Effect of Panchavalkaladi TailaYoni Pichu Dharan in the Management of Acharana Yonivyapad with Special Reference to Pruritus Vulvae

Dr Sayali Bharatkumar Vengurlekar1 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2025年2月20日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
76
试验地点
1
主要终点
Significantly reduction in Pruritus

研究概览

简要总结

Objective - To evaluate whether the Panchavalkaladi Taila Yoni Pichu Dharan in Acharana YoniVyapad (yoni kandu) with special reference to pruritus vulva

Group A - Panchavalkayadi tail

Group B - Nimb tail

Appropriate Sampling Technique: Simple randomised sampling method by computerised random technique will be done for 76 female patients of age group 18 to 70 years.

The subjects will be randomised in two study groups i.e., Group A and B. The time and date of recruitment shall also be recorded in the enrolment log

Follow up: 8 th day.

Assessment Criteria: The study will be strictly based on assessment of subjective parameter by the grading them.

The data obtained will be analyzed statistically.

Observation and Results: Observation and results will be drawn according to assessment criteria.

Discussion: The observed phenomena will be discussed.

Conclusion: Conclusion will be drawn strictly on basis of statistical analysis and will be unbiased

Summary: The research study will be summarized in brief.

Ethical Consideration: The study will be conducted in accordance with ethical guidelines and inform consent from participant.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
Female

入选标准

  • Female having per vaginal itiching.
  • Age between 18-70 yrs married female patient.
  • Female who are willing to participate.

排除标准

  • ) Pregnant women 2) Local gynaecological causes like ovarian cyst, prolapse, fibromyoma, polyps.
  • Neoplasm (Cervical or uterine malignancy) 4) patients with bleeding disorders 5) Those suffering from congenital anomalies of genital tract 6) Pelvic inflammatory diseases 7) Patients with sexually transmitted diseases 8) Abnormal uterine bleeding 9) Patients with severe hepatic or cardiac or renal disorders 10) Those having leukaemia or platelet deficiency disorders 11) Females in their puerperium period 12) Patient with severe anaemia 13) HIV HbsAg VDRL,HPV positive patients 14) Patients with DM,HTN.

结局指标

主要结局

Significantly reduction in Pruritus

时间窗: 8 days

次要结局

  • Significantly reduction in Pruritus by using Panchavalkayadi tail yoni pichu than Nimb tail yoni pichu(8 days)

研究者

发起方
Dr Sayali Bharatkumar Vengurlekar
申办方类型
Other []
责任方
Principal Investigator
主要研究者

DrSayali Bharatkumar Vengurlekar

R.A.Podar Medical (Ayu) college,worli

研究点 (1)

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